This document discusses how 21 CFR Part 11 (electronic records and signatures) relates to other FDA regulations known as "predicate rules".
It explains that predicate rules determine requirements around record creation, content, signatures, retention and archiving. Part 11 applies to electronic records and signatures for those required by predicate rules. The document provides examples of predicate rules for GLP, GCP, GMP and QSR. It also discusses concepts like raw data, signatures, time stamps, validation and record retention as they relate to both Part 11 and predicate rules.
Complying with 21 CFR Part 11 - Understanding the role of predicate ruleJasmin NUHIC
To obtain knowledge and understanding of 21 CFR Part 11 as how it applies to you as well as be advised of consequences which may result in failing to comply with this regulation.
This document discusses predicate rules and how 21 CFR Part 11, which governs electronic records and signatures, relates to and must be interpreted according to underlying FDA regulations known as predicate rules. It provides background on the CFR and gives examples of predicate rules for areas like GMPs, GLPs, and GCPs. It explains that Part 11 only applies to electronic records that are required by predicate rules, and that predicate rules determine requirements around record creation, content, signatures, and retention. The document uses guidance from the Part 11 guidance document to illustrate how predicate rules should be referenced in determining Part 11 compliance.
21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...ICHAPPS
TRAINING PROGRAMME ON
21CFR PARTS-210 AND 211
QUALITY ASSURANCE
Slideshow About 21 CFR
“Every product must be fit for its intended purpose”
“Every product must be fit for its intended purpose”
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES- UNITED STATES OF AMERICA
If you’re involved with the life sciences industry, odds are you’ve heard the term “21 CFR Part 11.” You may have gathered that it’s a set of regulations related to computer systems, but unless you work in a compliance group, you might not understand what it’s about or why it’s important.
In our webinar, Sally Miranker, head of computer system validation in Perficient’s life sciences practice, "decoded" the secrets of 21 CFR Part 11 on this somewhat mysterious set of regulations.
Building on our popular blog post series, Sally explained the regulations in layman’s terms and offered implementation insights and case study examples.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
This document provides an overview of 21 CFR Part 11, which establishes the criteria for accepting electronic records and electronic signatures. It discusses the key milestones in developing Part 11 and provides summaries of the general provisions, requirements for electronic records and signatures, and controls for closed and open systems. It also outlines some potential issues companies may face in complying with Part 11 and emphasizes the importance of security, access controls, and audit trails for electronic records systems.
21 CFR Part 11 Challenges and Solutions - White PaperNextDocs
Many sponsors are concerned with the risks and costs involved in ensuring that their electronic systems comply with the FDA’s ruling on
acceptance of Electronic Records and Electronic Signatures in place of their paper equivalents (21 CFR Part 11). Although the ruling has been in
place since 1997, there is often a lack of clarity concerning what characteristics and features a software solution must have to comply with 21 CFR
Part 11. Even when a solution meets all of its requirements, ensuring that procedural requirements are met may be a bigger challenge.
Although sponsors’ concerns are certainly valid, Part 11 compliance also provides an opportunity. Sponsors and the FDA share a common goal
of ensuring the integrity of their data, documentation and computer systems. If Part 11 compliance can be achieved by software configured to represent the sponsor’s desired business process, the burden on both system users and IT administrators can be minimal. The sponsor can then achieve benefits around both process automation and process transparency. The intent of this paper is to describe how NextDocs products provide a built-in platform for 21 CFR Part 11 compliance while providing capabilities that allow sponsors to automate, monitor and control their processes.
This document discusses 21 CFR Part 11, which sets criteria for electronic records, signatures, and computer systems used in clinical trials. It covers regulatory requirements, validation concepts and processes, roles in computerized system validation, and related FDA guidance. Warning letters and common questions about 21 CFR Part 11 are also mentioned.
Complying with 21 CFR Part 11 - Understanding the role of predicate ruleJasmin NUHIC
To obtain knowledge and understanding of 21 CFR Part 11 as how it applies to you as well as be advised of consequences which may result in failing to comply with this regulation.
This document discusses predicate rules and how 21 CFR Part 11, which governs electronic records and signatures, relates to and must be interpreted according to underlying FDA regulations known as predicate rules. It provides background on the CFR and gives examples of predicate rules for areas like GMPs, GLPs, and GCPs. It explains that Part 11 only applies to electronic records that are required by predicate rules, and that predicate rules determine requirements around record creation, content, signatures, and retention. The document uses guidance from the Part 11 guidance document to illustrate how predicate rules should be referenced in determining Part 11 compliance.
21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...ICHAPPS
TRAINING PROGRAMME ON
21CFR PARTS-210 AND 211
QUALITY ASSURANCE
Slideshow About 21 CFR
“Every product must be fit for its intended purpose”
“Every product must be fit for its intended purpose”
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES- UNITED STATES OF AMERICA
If you’re involved with the life sciences industry, odds are you’ve heard the term “21 CFR Part 11.” You may have gathered that it’s a set of regulations related to computer systems, but unless you work in a compliance group, you might not understand what it’s about or why it’s important.
In our webinar, Sally Miranker, head of computer system validation in Perficient’s life sciences practice, "decoded" the secrets of 21 CFR Part 11 on this somewhat mysterious set of regulations.
Building on our popular blog post series, Sally explained the regulations in layman’s terms and offered implementation insights and case study examples.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
This document provides an overview of 21 CFR Part 11, which establishes the criteria for accepting electronic records and electronic signatures. It discusses the key milestones in developing Part 11 and provides summaries of the general provisions, requirements for electronic records and signatures, and controls for closed and open systems. It also outlines some potential issues companies may face in complying with Part 11 and emphasizes the importance of security, access controls, and audit trails for electronic records systems.
21 CFR Part 11 Challenges and Solutions - White PaperNextDocs
Many sponsors are concerned with the risks and costs involved in ensuring that their electronic systems comply with the FDA’s ruling on
acceptance of Electronic Records and Electronic Signatures in place of their paper equivalents (21 CFR Part 11). Although the ruling has been in
place since 1997, there is often a lack of clarity concerning what characteristics and features a software solution must have to comply with 21 CFR
Part 11. Even when a solution meets all of its requirements, ensuring that procedural requirements are met may be a bigger challenge.
Although sponsors’ concerns are certainly valid, Part 11 compliance also provides an opportunity. Sponsors and the FDA share a common goal
of ensuring the integrity of their data, documentation and computer systems. If Part 11 compliance can be achieved by software configured to represent the sponsor’s desired business process, the burden on both system users and IT administrators can be minimal. The sponsor can then achieve benefits around both process automation and process transparency. The intent of this paper is to describe how NextDocs products provide a built-in platform for 21 CFR Part 11 compliance while providing capabilities that allow sponsors to automate, monitor and control their processes.
This document discusses 21 CFR Part 11, which sets criteria for electronic records, signatures, and computer systems used in clinical trials. It covers regulatory requirements, validation concepts and processes, roles in computerized system validation, and related FDA guidance. Warning letters and common questions about 21 CFR Part 11 are also mentioned.
Computer System Validation - The Validation Master PlanWolfgang Kuchinke
Computer System Validation (CSV) is the process used to ensure and document that a computerbased system is operating according to predefined requirements. CSV is necessary when replacing paper records, like
Case Report Forms for clinical trials, with an electronic system within the highly regulated data zone that impacts public health and safety. Necessary validation documents are for example the Standard Operating Procedures (SOPs), which outline how the computer system should be used. Here, we describe in detail the System Validation Master Plan, the most important document in Computer System Validation. In contains topics, like: Validation Policy, Definition of Validation, Rules and Regulations in CSV, Legal basis, FDA 21 CFR Part 11, FDA Guidance for industry, ICH Guideline GCP, Annex 11 EU-GMP, Validation Philosophy, Organisation validation document, Audit Reports, Organisation guidelines, Organisation quality management handbook, etc.
The steps of the Validation Life Cycle are: 1. System Specification, 2. System Classification, 3. Validation Planning, 4. Establishing of the validated state, 5. Maintaining the validated state, 6. System Retirement.
This document provides a checklist for compliance with 21 CFR Part 11, which establishes criteria for electronic records and electronic signatures. It discusses the need for validation, audit trails, electronic signatures, copies of records, and record retention. Each section provides points to evaluate like ensuring limited system access, time-stamped audit trails, unique electronic signatures, and the ability to produce accurate copies of electronic records. The document aims to help organizations evaluate their systems and processes to ensure compliance with FDA regulations for electronic records.
This presentation is compiled by Drug Regulations, a nonprofit organization that provides online pharmaceutical resources. It discusses FDA guidance on data integrity and compliance with cGMP regulations. The guidance clarifies FDA's expectations around the creation and handling of data to ensure its reliability and accuracy according to cGMP standards.
Process validation involves three key stages:
1) Process design to define the commercial manufacturing process based on development and scale-up.
2) Process qualification to evaluate the design and determine if reproducible commercial manufacturing is possible.
3) Continued process verification to ensure the process remains in control during routine production through monitoring and adjustment.
The document discusses change control procedures for pharmaceutical quality systems. It states that a formal change control system should be established to evaluate all changes that could affect production or quality. Changes should be properly identified, documented, reviewed, approved and implemented. Quality risk management should be used to evaluate planned changes and determine their potential impact. Changes require authorization and approval according to the quality system. The effectiveness of changes should be evaluated after implementation.
How to succeed when you get a FDA 483 form letter. What to do and how to handle your FDA 483. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-observations/
This document provides an overview of computer validation and compliance with regulatory guidance. It discusses the need for computer validation and outlines key principles from guidance documents such as software validation, use of off-the-shelf software in medical devices, and validation of electronic records and signatures. Validation approaches for different systems and software are covered, including spreadsheets. The document provides references to FDA and international regulatory guidance on these topics.
What is 21 CFR Part 11?:
21 CFR Part 11:
Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
To all FDA regulated environments
When using computers in the creation, modification, archiving, retrieval or transmission of data or records
To records required by predicate rules – GLP, GCP, GMP – that impact patient safety
To new and old systems
Purpose of Part 11
Ensure data is not corrupted or lost
Data is secure
Approvals cannot be repudiated
Changes to data can be traced
Attempts to falsify records are made difficult and can be detected
Types of Systems
Two types of systems that come under 21 CFR Part 11 – closed and open systems
Closed and Open Systems:
What is a Closed system?
A system to which access is controlled by person responsible for electronic records stored on it
What is an Open system?
A system to which access is not controlled by those responsible for the electronic records stored on it
21 CFR Part 11 Requirements:
21 CFR Part 11 lists the following controls for closed systems:
Validation
Device checks
Operational system checks
Accurate and complete copies
Accurate and steady retrieval
Limited access to systems and data
Authority checks
Electronic audit trail
Training/qualification of personnel
Accountability of signatures
Control over system documentation
Digital Signatures :
Use of digital signatures for open systems
Electronic Signatures
Requirements for signed electronic records
Linking records to signatures
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the 21 code of federal regulation Part 11.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
This document discusses various post-approval requirements and processes for pharmaceutical drugs, including prior approval supplements, changes being effected in 30 days supplements, annual reports, labeling changes, recalls, FDA inspections, and ISO 31000 risk management standards. It provides details on submission requirements and timelines for different types of post-approval changes, as well as FDA enforcement actions like warning letters, seizures, and injunctions.
Computer system validation review article by-mahesh b wazadeMahesh B. Wazade
Computer system validation (CSV) is the process of documenting that a computer system meets defined system requirements. It ensures computerized systems perform as intended in a consistent manner. CSV is important for regulated industries like pharmaceuticals where computer systems are used for quality control and record-keeping. Regulations like 21 CFR Part 11 require electronic records to be validated. CSV enhances reliability and reduces errors and risks to integrity.
This document outlines the internal audit policy for Khyber Pakhtunkhwa province in Pakistan. It establishes provincial and departmental internal audit cells to ensure effective internal controls, transparency, and proper use of resources. The policy defines the purpose, scope, organization, responsibilities, and standards of the internal audit cells. It aims to ensure accurate financial reporting, compliance with laws, safeguarding of assets, and achievement of objectives.
The Code of Federal Regulations (CFR) is the codification of rules and regulations issued by federal agencies in the United States. It is divided into 50 titles that represent broad subject areas subject to regulation, such as transportation, banks and banking, food and drugs. Within each title are chapters and parts that contain the specific regulations. The CFR is updated annually and published online daily. Title 21 of the CFR governs regulations relating to food and drugs and is divided into three chapters covering the Food and Drug Administration, Drug Enforcement Administration, and Office of National Drug Control Policy.
This document provides an overview of FDA regulations 21 CFR Parts 210 and 211, which establish current Good Manufacturing Practices (cGMP) for manufacturing, processing, packing, or holding of drugs.
The summary includes definitions of key terms such as batch, component, drug product, and quality control. It also summarizes some of the major requirements for facilities, equipment, components, containers and closures, organization and personnel, and production and process controls to ensure identity, strength, quality and purity of drug products. The goal of Parts 210 and 211 is to provide minimum requirements and requirements for quality systems, not prescribe specific ways to meet those requirements.
A guide for how to survive a FDA Warning letter. So you got at FDA 483 and now you have a FDA Warning Letter, learn how to survive the storm. For more information go to http://compliance-insight.com/fda-483-warning-letters/
The document provides guidance on preparing for a computer systems quality audit by outlining key elements of a quality assurance program including standard operating procedures, a change control program, and computer systems validation. It describes the components and purpose of the change control program and committees. It also lists important documents needed for a computer systems validation program including plans, procedures, and project documents.
The document summarizes the Code of Federal Regulations Title 21 Part 822, which provides procedures and requirements for post-market surveillance of medical devices. It outlines the subparts which address general provisions, notification, post-market surveillance plans, FDA review and action, responsibilities of manufacturers, waivers and exemptions, and records and reports. The purpose is to implement post-market surveillance authority to maximize collection of useful safety data on medical devices after market release. Manufacturers must submit surveillance plans for FDA approval and are responsible for conducting approved plans to monitor devices and report data and issues.
Presentation at ACI Conference on FDA Enforcement, covered:
Warning Letters, FDA Case Referral Process/Role of DOJ and U.S. Attorney, Coordination with States, Collateral Consequences of FDA Enforcement Actions
The document discusses Good Automated Manufacturing Practice (GAMP), which are guidelines for manufacturers and users of automated systems in the pharmaceutical industry published by the International Society for Pharmaceutical Engineering (ISPE). GAMP aims to ensure pharmaceutical products have the required quality by establishing principles and procedures for validating automated systems. Key aspects of GAMP covered in the document include focusing on building quality into each stage of manufacturing rather than testing it in, covering all production aspects from raw materials to staff training. The document also summarizes the GAMP5 guidelines released in 2008, which provide a framework for validating computerized systems to ensure they are fit for use and compliant with regulations. GAMP5 emphasizes product and process understanding, a lifecycle approach,
Gain the latest insight (2013) into 21 CFR Part 11 Compliance from AITalent's latest Webinar.
Discover:
Part 11 – What it is not, the myths.
Part 11 – What it is, the facts.
Part 11 – What does the future hold?
Find out more: www.aitalent.co.uk
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
Computer System Validation - The Validation Master PlanWolfgang Kuchinke
Computer System Validation (CSV) is the process used to ensure and document that a computerbased system is operating according to predefined requirements. CSV is necessary when replacing paper records, like
Case Report Forms for clinical trials, with an electronic system within the highly regulated data zone that impacts public health and safety. Necessary validation documents are for example the Standard Operating Procedures (SOPs), which outline how the computer system should be used. Here, we describe in detail the System Validation Master Plan, the most important document in Computer System Validation. In contains topics, like: Validation Policy, Definition of Validation, Rules and Regulations in CSV, Legal basis, FDA 21 CFR Part 11, FDA Guidance for industry, ICH Guideline GCP, Annex 11 EU-GMP, Validation Philosophy, Organisation validation document, Audit Reports, Organisation guidelines, Organisation quality management handbook, etc.
The steps of the Validation Life Cycle are: 1. System Specification, 2. System Classification, 3. Validation Planning, 4. Establishing of the validated state, 5. Maintaining the validated state, 6. System Retirement.
This document provides a checklist for compliance with 21 CFR Part 11, which establishes criteria for electronic records and electronic signatures. It discusses the need for validation, audit trails, electronic signatures, copies of records, and record retention. Each section provides points to evaluate like ensuring limited system access, time-stamped audit trails, unique electronic signatures, and the ability to produce accurate copies of electronic records. The document aims to help organizations evaluate their systems and processes to ensure compliance with FDA regulations for electronic records.
This presentation is compiled by Drug Regulations, a nonprofit organization that provides online pharmaceutical resources. It discusses FDA guidance on data integrity and compliance with cGMP regulations. The guidance clarifies FDA's expectations around the creation and handling of data to ensure its reliability and accuracy according to cGMP standards.
Process validation involves three key stages:
1) Process design to define the commercial manufacturing process based on development and scale-up.
2) Process qualification to evaluate the design and determine if reproducible commercial manufacturing is possible.
3) Continued process verification to ensure the process remains in control during routine production through monitoring and adjustment.
The document discusses change control procedures for pharmaceutical quality systems. It states that a formal change control system should be established to evaluate all changes that could affect production or quality. Changes should be properly identified, documented, reviewed, approved and implemented. Quality risk management should be used to evaluate planned changes and determine their potential impact. Changes require authorization and approval according to the quality system. The effectiveness of changes should be evaluated after implementation.
How to succeed when you get a FDA 483 form letter. What to do and how to handle your FDA 483. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-observations/
This document provides an overview of computer validation and compliance with regulatory guidance. It discusses the need for computer validation and outlines key principles from guidance documents such as software validation, use of off-the-shelf software in medical devices, and validation of electronic records and signatures. Validation approaches for different systems and software are covered, including spreadsheets. The document provides references to FDA and international regulatory guidance on these topics.
What is 21 CFR Part 11?:
21 CFR Part 11:
Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
To all FDA regulated environments
When using computers in the creation, modification, archiving, retrieval or transmission of data or records
To records required by predicate rules – GLP, GCP, GMP – that impact patient safety
To new and old systems
Purpose of Part 11
Ensure data is not corrupted or lost
Data is secure
Approvals cannot be repudiated
Changes to data can be traced
Attempts to falsify records are made difficult and can be detected
Types of Systems
Two types of systems that come under 21 CFR Part 11 – closed and open systems
Closed and Open Systems:
What is a Closed system?
A system to which access is controlled by person responsible for electronic records stored on it
What is an Open system?
A system to which access is not controlled by those responsible for the electronic records stored on it
21 CFR Part 11 Requirements:
21 CFR Part 11 lists the following controls for closed systems:
Validation
Device checks
Operational system checks
Accurate and complete copies
Accurate and steady retrieval
Limited access to systems and data
Authority checks
Electronic audit trail
Training/qualification of personnel
Accountability of signatures
Control over system documentation
Digital Signatures :
Use of digital signatures for open systems
Electronic Signatures
Requirements for signed electronic records
Linking records to signatures
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the 21 code of federal regulation Part 11.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
This document discusses various post-approval requirements and processes for pharmaceutical drugs, including prior approval supplements, changes being effected in 30 days supplements, annual reports, labeling changes, recalls, FDA inspections, and ISO 31000 risk management standards. It provides details on submission requirements and timelines for different types of post-approval changes, as well as FDA enforcement actions like warning letters, seizures, and injunctions.
Computer system validation review article by-mahesh b wazadeMahesh B. Wazade
Computer system validation (CSV) is the process of documenting that a computer system meets defined system requirements. It ensures computerized systems perform as intended in a consistent manner. CSV is important for regulated industries like pharmaceuticals where computer systems are used for quality control and record-keeping. Regulations like 21 CFR Part 11 require electronic records to be validated. CSV enhances reliability and reduces errors and risks to integrity.
This document outlines the internal audit policy for Khyber Pakhtunkhwa province in Pakistan. It establishes provincial and departmental internal audit cells to ensure effective internal controls, transparency, and proper use of resources. The policy defines the purpose, scope, organization, responsibilities, and standards of the internal audit cells. It aims to ensure accurate financial reporting, compliance with laws, safeguarding of assets, and achievement of objectives.
The Code of Federal Regulations (CFR) is the codification of rules and regulations issued by federal agencies in the United States. It is divided into 50 titles that represent broad subject areas subject to regulation, such as transportation, banks and banking, food and drugs. Within each title are chapters and parts that contain the specific regulations. The CFR is updated annually and published online daily. Title 21 of the CFR governs regulations relating to food and drugs and is divided into three chapters covering the Food and Drug Administration, Drug Enforcement Administration, and Office of National Drug Control Policy.
This document provides an overview of FDA regulations 21 CFR Parts 210 and 211, which establish current Good Manufacturing Practices (cGMP) for manufacturing, processing, packing, or holding of drugs.
The summary includes definitions of key terms such as batch, component, drug product, and quality control. It also summarizes some of the major requirements for facilities, equipment, components, containers and closures, organization and personnel, and production and process controls to ensure identity, strength, quality and purity of drug products. The goal of Parts 210 and 211 is to provide minimum requirements and requirements for quality systems, not prescribe specific ways to meet those requirements.
A guide for how to survive a FDA Warning letter. So you got at FDA 483 and now you have a FDA Warning Letter, learn how to survive the storm. For more information go to http://compliance-insight.com/fda-483-warning-letters/
The document provides guidance on preparing for a computer systems quality audit by outlining key elements of a quality assurance program including standard operating procedures, a change control program, and computer systems validation. It describes the components and purpose of the change control program and committees. It also lists important documents needed for a computer systems validation program including plans, procedures, and project documents.
The document summarizes the Code of Federal Regulations Title 21 Part 822, which provides procedures and requirements for post-market surveillance of medical devices. It outlines the subparts which address general provisions, notification, post-market surveillance plans, FDA review and action, responsibilities of manufacturers, waivers and exemptions, and records and reports. The purpose is to implement post-market surveillance authority to maximize collection of useful safety data on medical devices after market release. Manufacturers must submit surveillance plans for FDA approval and are responsible for conducting approved plans to monitor devices and report data and issues.
Presentation at ACI Conference on FDA Enforcement, covered:
Warning Letters, FDA Case Referral Process/Role of DOJ and U.S. Attorney, Coordination with States, Collateral Consequences of FDA Enforcement Actions
The document discusses Good Automated Manufacturing Practice (GAMP), which are guidelines for manufacturers and users of automated systems in the pharmaceutical industry published by the International Society for Pharmaceutical Engineering (ISPE). GAMP aims to ensure pharmaceutical products have the required quality by establishing principles and procedures for validating automated systems. Key aspects of GAMP covered in the document include focusing on building quality into each stage of manufacturing rather than testing it in, covering all production aspects from raw materials to staff training. The document also summarizes the GAMP5 guidelines released in 2008, which provide a framework for validating computerized systems to ensure they are fit for use and compliant with regulations. GAMP5 emphasizes product and process understanding, a lifecycle approach,
Gain the latest insight (2013) into 21 CFR Part 11 Compliance from AITalent's latest Webinar.
Discover:
Part 11 – What it is not, the myths.
Part 11 – What it is, the facts.
Part 11 – What does the future hold?
Find out more: www.aitalent.co.uk
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
The document summarizes key FDA regulations and guidance related to electronic records and electronic signatures, including 21 CFR Part 11. It outlines requirements for electronic signatures from regulations like 21 CFR Part 11, Annex 11, and guidance documents from the FDA and EMA. The document emphasizes that these regulations apply to all electronic records, not just those with electronic signatures, and are intended to help catch criminals by ensuring the integrity of electronic records and signatures.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
This document discusses handling deviations from standard operating procedures in quality management systems. It defines a deviation as any departure from approved instructions or established standards. Deviations are classified as either planned or unplanned. Unplanned deviations require investigation to determine the root cause and implement corrective and preventive actions. The investigation process involves documenting the event, taking immediate action, analyzing the root cause, implementing corrective actions, and evaluating effectiveness. Guidelines such as ICH Q7 provide requirements for deviation handling, investigation, and corrective action to prevent future deviations.
The document outlines the key aspects of current good manufacturing practices (cGMPs) that pharmaceutical manufacturers must follow. cGMPs come from the Food, Drug and Cosmetic Act and are enforced by the FDA. They help ensure safety and quality by requiring strict control over facilities, equipment, components, packaging, labeling, and processes. Key parts of cGMP regulations address organization, buildings, equipment, materials control, production, packaging, holding, distribution, and records. Failure to comply can result in serious legal and business consequences like product recalls or plant shutdowns.
The document discusses Good Manufacturing Practices (GMP) and contamination prevention. It covers types of contamination, sources, and how to prevent them through practices like personal hygiene, sanitation, cleaning, and equipment maintenance. GMP regulations require facilities, equipment, personnel training, and documentation to help assure product quality and safety.
CIS14: Case Study: Using a Federated Identity Service for Faster Application ...CloudIDSummit
Rowland Nicholson, Caterpillar, Inc.
Case study of how Caterpillar used identity virtualization to aggregate, correlate and remap identities to create virtual views, enabling each application to have the required identity information on demand.
An Integrated Science Cyberinfrastructure for Data-Intensive ResearchLarry Smarr
This document summarizes Dr. Larry Smarr's vision for an integrated science cyberinfrastructure to support data-intensive research. It discusses the exponential growth of digital data and need for dedicated high-bandwidth networks and data repositories. Specific examples are provided of initiatives at UCSD, regional optical networks connecting research institutions, and national projects like the Open Science Grid and Cancer Genomics Hub that are creating cyberinfrastructure to enable data-intensive scientific discovery.
CIS14: Why Federated Access Needs a Federated IdentityCloudIDSummit
Matt Tatro, Denise Lores, Wade Ellery
Radiant Logic
How creating a federated identity service gives you a single unified view of ALL identities and their context to improve your federated access, WAM and application deployment.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
This document provides an overview of AWS Cloud Governance. It discusses that governance implies control and oversight over policies, procedures, and standards for application development. Governance in the cloud is a shared responsibility between cloud providers and consumers. AWS investments establish a trusted foundation through certifications like SOC 1 Type 2, ISO 27001, and PCI DSS. AWS technologies that can help with governance include IAM, VPC, CloudWatch, and storage/database services. The document outlines how these services can help with roles and access controls, network security, monitoring, disaster recovery and more. It provides references for further reading on cloud governance best practices.
Static Analysis and the FDA Guidance for Medical Device SoftwareErika Barron
This document discusses how static analysis and the MISRA coding standards can help medical device companies comply with FDA guidelines for software development. It provides an overview of the FDA's guidance on software validation and defect prevention. The document argues that MISRA is a good option for medical software because it provides well-defined, auditable coding standards and a process for justifying and documenting deviations. Adopting MISRA allows companies to leverage its proven standards and traceability features to facilitate FDA compliance and software quality.
The document provides an overview of quality systems for medical device manufacturers. It discusses the components required by the FDA's Quality System Regulation, including management responsibility, design controls, document controls, purchasing controls, production and process controls, and acceptance activities. It emphasizes that quality systems help ensure consistent compliance with requirements and specifications to improve safety and efficacy.
FDA 2013 Clinical Investigator Training Course: CMC and Investigator Brochure...MedicReS
This document summarizes key CMC (chemistry, manufacturing, and controls) requirements for clinical trial materials submitted in an investigational new drug (IND) application. It discusses ensuring the identity, quality, purity and strength of the drug substance and drug product. Impurities are identified as a major safety concern that could cause an IND to be placed on clinical hold. The level of CMC information required in an IND increases with later phases of clinical trials. Guidance documents and meetings with FDA are recommended to facilitate drug development.
You are about to embark on a journey of becoming a SharePoint Designer Ninja. SharePoint has infiltrated within your company and you want to master the art of css, master pages and page layouts. Within this one hour session, I will teach you the countermeasures required to masterfully brand SharePoint to your will. During this session, we will brand a site from scratch with our bare hands and this will be the initiation into the SharePoint Design. At the end of this session, I’ll teach you legendary abilities of SharePoint Designers including invisibility, walking on water, and control over master page content placeholders. You’ll also be given some secrets from within the walls of the Oniwaban such as practical tips, tricks, and advice so that you too can one day become a SharePoint Design Ninja.
http://www.kanwalkhipple.
This certificate certifies that Vincent Leonardi Lioe successfully completed an educational video training on the basic introduction of Quality System Regulation 21 CFR 820. The training was sponsored by the U.S. Food and Drug Administration Center for Devices and Radiological Health and was issued on July 07, 2011 with certificate number 110707478788.
Clear cut line by line interpretation on 21 cfr part 11Pari S
This document provides an interpretation and explanation of key terms and regulations within 21 CFR Part 11, which governs electronic records and signatures for the pharmaceutical industry. It breaks down Part 11 into sections, providing definitions and interpreting the purpose and scope of each regulation. The overall objective is to help ensure data integrity for electronic records by explaining how organizations can design computer systems and controls that enable the FDA to accept electronic records and signatures equivalent to paper ones.
The document summarizes Title 21 of the Code of Federal Regulations (CFR), which governs food and drugs in the United States. Title 21 is divided into three chapters covering regulations from the Food and Drug Administration, Drug Enforcement Administration, and Office of National Drug Control Policy. Key parts of Title 21 discussed include Part 11 on electronic records and signatures, Part 210 on current good manufacturing practices for drugs, and Part 211 on manufacturing practices for finished pharmaceuticals. These parts establish requirements for electronic documentation, quality control in drug production, and ensuring drug identity, strength, purity and consistency in manufacturing.
The document discusses the Code of Federal Regulations (CFR) Title 21, which deals with governing food and drugs in the United States. It is divided into 3 chapters that cover the Food and Drug Administration, Drug Enforcement Agency, and Office of National Drug Control Policy. Part 11 of Title 21 specifically addresses electronic records and electronic signatures for pharmaceuticals and medical devices.
Achieving 21 Code of Federal Regulations (CFR) Part11SamuelP9
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The document discusses the role of Waters Empower Software in assisting companies with 21 CFR Part 11 compliance. 21 CFR Part 11 is the FDA's rule governing electronic records and electronic signatures, which has significant implications for regulated life science industries. The summary discusses how Empower Software provides technical controls to help meet the requirements of 21 CFR Part 11, including accurately archiving and retrieving machine-readable and human-readable data, limiting system access through login credentials, capturing audit trails of user actions, and employing role-based privileges to control system access. Empower Software is presented as a tool to help life science companies achieve compliance with 21 CFR Part 11.
The document discusses the role of Waters Empower Software in assisting companies with 21 CFR Part 11 compliance. 21 CFR Part 11 is the FDA's rule governing electronic records and electronic signatures, which has significant implications for regulated life science industries. The summary discusses how Empower Software provides technical controls to help meet the requirements of 21 CFR Part 11, including accurately archiving and retrieving machine-readable and human-readable data, limiting system access through login credentials, capturing audit trails of user actions, and employing role-based privileges to control system access. Empower Software is presented as a tool to help life science companies achieve compliance with 21 CFR Part 11.
The FDA oversees clinical trials through inspections and monitoring. The FDA can inspect sponsor and investigator records and reports relating to clinical trials. Sponsors are responsible for monitoring trials and selecting qualified monitors. The FDA's Bioresearch Monitoring Program conducts inspections using compliance program manuals to inspect clinical investigators, sponsors, IRBs, and nonclinical laboratories. Inspections verify compliance and ensure accurate and reliable trial data.
The document discusses the FDA's 21 CFR Part 11 regulation on electronic records and signatures. It provides definitions and terminology used in the regulation. The regulation requires three levels of control - administrative, procedural, and technical. It also contains two major subparts on electronic records and electronic signatures. Tables 1 and 2 show how the ComplianceWire system addresses the specific requirements for electronic records and signatures outlined in the two subparts. The purpose is to help FDA-regulated industries quickly and cost-effectively comply with 21 CFR Part 11.
21 CFR Part 11–The Biggest Security Regulation You Never Heard OfBen Rothke
21 CFR Part 11 is a huge FDA regulation dealing with electronic records and signatures that many people are unaware of. It requires controls be implemented for electronic records to ensure they are as trustworthy as paper records. Part 11 aims to enable electronic drug applications and reduce paper use. It requires procedures for access control, audit trails, and ensuring only authorized users can access systems and data. While originally intended to reduce costs, non-compliance can result in large fines.
21 CFR Part 11–The Biggest Security Regulation You Never Heard OfBen Rothke
21 CFR Part 11 is a huge FDA regulation dealing with electronic records and signatures that many people are unaware of. It requires controls be implemented for electronic records to ensure they are as trustworthy as paper records. Part 11 aims to enable electronic drug applications and reduce paperwork. It addresses security, audit trails, and ensuring only authorized access. While originally intended to reduce costs, Part 11's main requirement is now security to ensure the same degree of confidence in electronic records as paper. Non-compliance can result in large fines.
The Code of Federal Regulations (CFR) is the codification of rules and regulations issued by federal agencies in the United States. It is divided into 50 titles that broadly categorize the subject areas covered. Within each title are chapters and parts that further break down the regulations. The CFR is updated throughout the year and republished annually. It provides the framework for many areas of federal regulation and enforcement.
The document discusses FDA regulations on electronic records and electronic signatures (Part 11). It summarizes that Part 11 establishes criteria for electronic records and signatures to be considered equivalent to paper records. It defines controls for closed and open systems, including limiting access, operational checks, authority checks, device checks, education for system users, policies for electronic signatures, and controls over documentation and data.
The document provides an overview of computerized system validation. It defines computerized system validation as the process of testing, validating, and qualifying a regulated computerized system to ensure it operates as designed in a consistent and reproducible manner. The document discusses the difference between computer systems and computerized systems, why validation is needed in the pharmaceutical industry, types of validation, applicable regulatory requirements like 21 CFR Part 11, and the GAMP 5 categories for classifying computerized systems. It provides key points about computerized system validation and the V-model approach for validation stages and deliverables.
Clinical Trial Regulations in The USA.pdfProRelixInfo
Historical events such as the sulfanilamide elixir tragedy that resulted in the mass poisoning and the deaths of hundreds of patients in the 1930s and the thalidomide scandal which caused birth defects and mortality of babies prompted the United States Congress to enact legislation pertaining to the regulation of drugs, medical devices, biologicals, and food articles that involved an extensive safety evaluation of products prior to marketing authorization. The Federal Food, Drug, and Cosmetic Act of 1938 was enacted with the primary purpose of consumer protection in mind and to ensure the safety and well-being of all people consuming or utilizing the products mentioned in the Act. Several years later, the United States remains as having the strictest regulations and laws relating to clinical research in human subjects, and rightly so as patient health, well-being, and integrity are of paramount importance in all aspects of Good Clinical Practice (GCP) guidelines.
This document discusses recommendations for changes to FDA's 21 CFR Part 11 regulations based on a presentation given by the National Electrical Manufacturers Association (NEMA) to the FDA. It argues that Part 11 is duplicative of existing "predicate rules" like Quality System Regulations, Medical Device Reporting regulations, and Good Laboratory Practice regulations. It proposes that Part 11 should either be withdrawn in favor of the predicate rules, or changed to a less prescriptive guidance document, to reduce regulatory burden while still meeting FDA's objectives. The predicate rules are said to adequately protect public health and cover all phases of product development and problem reporting.
The document provides an overview of Good Clinical Practice (GCP) guidelines. It discusses:
1) How GCP standards were developed to ensure clinical trials are conducted ethically and that trial data is accurate. This includes guidelines from the Declaration of Helsinki, International Conference on Harmonization, and US regulations.
2) The key documents that define GCP responsibilities, including ICH E6, FDA regulations around informed consent and monitoring, and the Common Rule for research involving human subjects.
3) How GCP guidelines continue to evolve with new standards from organizations like the FDA, WHO and revisions to founding documents like the Declaration of Helsinki. Compliance with GCP is important for researchers, sponsors and IRBs conducting
21 CFR Part 11, commonly referred to as “Part 11” is a set of rules that specifies what is required for electronic records and signatures. The regulatory framework outlines the management of records in Electronic Quality Management Systems for Life Science and other FDA-regulated industries.
Why is it called 21 CFR Part 11?
What is 21 CFR Part 11? CFR stands for “Code of Federal Regulation.” 21 CFR Part 11, in particular, details the criteria under which electronic records and signatures are considered to be trustworthy and equivalent to paper records.
What are the 21 CFR rules?
21 CFR Rules set out guidelines on the usages and management of electronic records as well as electronic signatures. As such, as the user of electronic data records, you are guided by 21 CFR rules so that you can have optimal benefits from the data and also act in integrity.
(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means.
(c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997.
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Siro clinical research institute
Post graduate Diploma in Clinical Research
The Code of Federal Regulations (CFR) is the codification of rules and regulations issued by federal agencies in the United States. It is divided into 50 titles that represent broad subject areas subject to federal regulation. The CFR is updated through rules published in the Federal Register and issued as soft-cover volumes on a quarterly basis. It is also available online through the Electronic CFR, which is updated more frequently. Title 21 of the CFR covers regulations related to food and drugs, including current good manufacturing practice regulations for pharmaceuticals.
The document discusses current Good Manufacturing Practices (cGMP) regulations enforced by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities. It provides an overview of key topics including:
- What cGMPs are and why they are important to assure drug quality and purity.
- Where cGMP regulations come from, including the Federal Food, Drug, and Cosmetic Act and sections in the Code of Federal Regulations (CFR) that pertain specifically to drug and device cGMPs.
- Some examples of cGMP requirements the FDA evaluates, such as those related to quality control responsibilities and personnel qualifications, as well as examples of evidence manufacturers can provide to demonstrate compliance.
Similar to Interpretation of Part 11 by the GxP Predicate Rules (20)
2. Agenda
Predicate Rules Background
Predicate Rules and 21 CFR Part 11
A Few Examples of Where in the GxPs
Records are Required to be Created
and Maintained
Sigs Too!
3. How Does It Work?
Laws within the US are formulated by Congress
and enter into the United States Code of Federal
Regulations
Once approved by Congress and the President
The United States Code of Federal Regulations
(CFR) is official record of all US Federal Law
Holds regs for the implementation of the US Acts (Laws)
The root of the US document hierarchy
Proposed regs are first published in the Federal
Register for public comment
Once approved, entered in final form into the CFR
http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=199821
4. The CFR
The Code of Federal Regulations is
divided into Titles…
The two Titles relevant to Pharma are…
Title 21 Food and Drugs
Title 42 The Public Health and Welfare
Within Title 21 that we find various “Parts”
e.g. 21 CFR Part 11 on ERES and 21 CFR
Part 820 on Quality Systems
5. Title 21 and 42
Each contains chapters dealing with a wide
range of food, drug and health issues
The important chapter in Title 21 is Chapter
9, the Federal Food, Drug, and Cosmetic
Act (The Act)
Title 21 §393 authorizes the existence of the
FDA as part of the US Department of Health
and Human Services, to carry out its duties
Title 42, Public Health, contains Chapter
6A, the Public Health Service Act (PHS)
6. Other “Parts”
21 CFR Part 312: Investigational New Drug
Application
21 CFR Part 314: Application For FDA Approval To
Market New Drug
21 CFR Part 52: Obligation of Sponsors and
Monitors of Clinical Investigation
21 CFR Part 54: Financial Disclosure by Clinical
Investigators
21 CFR Part 50: Protection of Human Subjects
21 CFR Part 56: Institutional Review Boards
21 CFR Part 310: New Drugs
21 CFR Part 820: Quality System Regulation
http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1
7. So What Are The Predicate Rules?
“The Underlying Requirements Set Forth in the US
Federal Food, Drug, and Cosmetic Act (The Act),
US Public Health Service (PHS) Act,
..and FDA Regulations Under Title 21 are Referred
to in the Part 11 Guidance Document as….
Predicate Rules”.
The term “predicate rules” should really only be used in
relation to US regulations
However, there is creeping usage of the term to refer to
both US and European higher-level regulations
8. Scope, 21 CFR 11.1
Records are Required by a “Predicate Rule”
Predicate Rules, not Part 11, Determine:
Record creation
Record content
Record signature requirements
Record retention period
Archiving
Original vs copy
9. Guidance Documents
In Addition to the Regulations in the CFR,
the FDA Also Publishes a Number of
Guidance Documents
To Assist in Understanding the Various
Rules and Regulations
Not Binding on the Industry or Agency
Only Represent the FDA’s “Current
Thinking”
“Contains Non-Binding Recommendations”
10. What About E-Signatures?
For Electronic Signatures, the Requirements
Imposed Upon Systems Not Only Come
Form Pharmaceutical Regulations but From
Other Legislation
Such as the ….
US E-sign Act (2000)
EU Directive 1999/93/EC on Electronic
Signatures
12. The Predicate Rules
GLP:
21 CFR 58 Good Laboratory Practice for Non-Clinical Lab Studies
GCP:
21 CFR 310 New Drugs
21 CFR 312 Investigational New Drug Application
21 CFR 314 Applications For FDA Approval To Market A New Drug
21 CFR 510 New Animal Drugs
21 CFR 511 New Animal Drugs For Investigational Use
21 CFR 514 New Animal Drug Applications
GMP:
21 CFR 210 Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or
Holding Of Drugs
21 CFR 211 Current Good Manufacturing Practice For Finished Pharmaceuticals
QSR:
21 CFR 820 Quality System Regulation
Food related "GMPs"; ‘GOOD FOOD PRACTICES’:
PART 106 Infant Formula QC Procedures
PART 110 Current Good Manu Practice in Manu, Packing and Holding Human Food
PART 113/114 Thermally Processed and Acidified Low-Acid Canned Foods
PART 123 Fish and Fishery Products
PART 129 Bottled Drinking Water
13. Records and Signatures Subject to
Part 11
Any Record Required by FDA that is in
Electronic Form
Any Electronic Signature that Appears
in an FDA-required Record, Whether
or Not Signature is Required
Electronic Submissions to FDA
15. Importance of Predicate Rules
21 CFR 11 Interpretation Always via Predicate Rules
GMP, GLP, GCP
Draft Guidance Places Increased Emphasis on Predicate Rule
Interpretation
Not all e-records produced by a company are Part 11 records
Documented assessment
Read predicate rules and understand where records and
signatures are required
How Will Investigator Evaluate Compliance With Part 11
During an Inspection for Another Purpose?
An investigator will look at records to evaluate compliance with
the predicate rule. At the same time, the investigator may check
compliance with Part 11 for adequacy of recordkeeping.
16. Understanding Predicate Rules
Some Requirements for Signatures
are Explicit:
“signature or initials”
“handwritten, full signature”
Others are Implicit:
“approved”
“authorized”
17. Part 11 Guidance Document Predicate
Rule Reference: Triggering Part 11
Under narrow interpretation, FDA considers Part 11 to be
applicable to the following records or signatures in electronic
format:
Records that are required to be maintained under predicate rule
requirements and that are maintained in electronic format in
place of paper format. On the other hand, records (and any
associated signatures) that are NOT required to be retained
under predicate rules, but that are nonetheless maintained in
electronic format, are NOT part 11 records.
We recommend that you determine, based on the predicate
rules, whether specific records are Part 11 records. We
recommend that you document such decisions.
18. Guidance Document Predicate Rule
Reference: Time Stamps
“Persons must still comply with all
applicable predicate rule requirements
related to…
…documentation of….
…date, time, or sequencing of events…
…and requirements for ensuring that
changes to records do not obscure
previous entries.”
e.g., § 58.130(e)
19. 11 Guidance Document Predicate
Rule Reference: e-Signatures
“Electronic signatures that are intended to
be the equivalent of handwritten signatures,
initials, and other general signings required
by predicate rules. Part 11 signatures
include electronic signatures that are used,
for example, to document the fact that
certain events or actions occurred in
accordance with the predicate rule (e.g.
approved, reviewed, and verified).”
20. “….must still comply with all applicable
predicate rule requirements for
validation (e.g., 21 CFR 820.70(i)).”
“We suggest that your decision to
validate computerized systems, and
the extent of the validation, take into
account the impact the systems have
on your ability to meet predicate rule
requirements.”
Part 11 Guidance Document Predicate Rule
Reference: Validation
21. “The system [must meet] all applicable predicate
rule requirements before the effective date.”
“The system [must] currently meet all applicable
predicate rule requirements.”
“If a system has been changed since August 20,
1997, and if the changes would prevent the system
from meeting predicate rule requirements, Part 11
controls should be applied to Part 11 records and
signatures…”
Part 11 Guidance Document Predicate
Rule Reference: Legacy Systems
22. Part 11 Guidance Document Predicate
Rule Reference: Copies of Records
“All records held by you are subject to
inspection in accordance with
predicate rules (e.g., §§ 211.180(c),
(d), and 108.35(c)(3)(ii)).”
23. “Persons must still comply with all applicable predicate rule
requirements for record retention and availability (e.g., §§
211.180(c),(d), 108.25(g), and 108.35(h)).”
“We suggest that your decision on how to maintain records be
based on predicate rule requirements and that you base
your decision on a justified and documented risk assessment
and a determination of the value of the records over time.”
“Persons must still comply with all predicate rule
requirements, and the records themselves and any copies of
the required records should preserve their content and
meaning.”
“As long as predicate rule requirements are fully satisfied
and the content and meaning of the records are preserved
and archived, you can delete the electronic version of the
records.”
Part 11 Guidance Document Predicate
Rule Reference: Record Retention
24. 21 CFR Part 211 cGMP
§211.182 – Equipment Cleaning and Use Log
§211.184 – Component, Drug Product Container,
Closure and Labeling Records
§211.186 – Master Production and Control Records
§211.188 – Batch Production and Control Records
§211.192 – Production Record Review
§211.194 – Laboratory Records
§211.196 – Distribution Records
§211.198 – Complaint Files
25. 21 CFR Part 211 cGMP
For Finished Pharmaceuticals
Covers Use of Computers
§211.68; Automatic, mechanical and electronic
electronic equipment
Covers Use of Records
§211.180 – 211.198; Records and reports
26. §211.194 : Order of Signing
Laboratory Records
(7) The initials or signature of the person who performs
each test and the date(s) the tests were performed.
(8) The initials or signature of a second person showing
that the original records have been reviewed for accuracy,
completeness and compliance with established standards.
Evaluate Systems Carefully:
What is a signature versus identification of action
Two signatures only required for each test
Order of signing is important: technical control for system
27. §211.100: Written Procedures;
Deviations
(a)…. These written procedures, including and
changes shall be drafted, reviewed and approved
by the appropriate organizational units and
reviewed and approved by the quality control unit.
(b)… Any deviation from the written procedure shall
be recorded and justified.
No Stated Requirement for a Record of the Paper
Procedure
Defined Sign-offs Required for the Final Procedure
Deviations: No Stated Requirement for Signatures
or Initials
28. Part 211: Record Requirements
§211.188 Batch Production & Control
Records
Batch production and control records shall be
prepared for each batch of drug product
produced and shall include complete information
relating to the production and control of each
batch
§211.194(a) Laboratory Records
Laboratory records shall include complete data
derived from all tests necessary to assure
compliance with established specifications and
standards
29. § 211.68: Record Requirements
For Automatic, Mechanical and Electronic
Equipment
(a) Automatic, mechanical, or electronic equipment
or other types of equipment, including computers,
or related systems that will perform a function
satisfactorily, may be used in the manufacture,
processing, packing, and holding of a drug product.
If such equipment is so used, it shall be routinely
calibrated, inspected, or checked according to a
written program designed to assure proper
performance. Written records of those calibration
checks and inspections shall be maintained.
30. Record Integrity: §211.68(b)
(b) Appropriate controls shall be exercised over
computer or related systems to assure that
changes in master production and control records
or other records are instituted only by authorized
personnel. Input to and output from the computer
or related system of formulas or other records or
data shall be checked for accuracy.
The degree and frequency of input/output
verification shall be based on the complexity and
reliability of the computer or related system.
31. Record Back-up: §211.68(b)
A backup file of data entered into the computer or related
system shall be maintained except where certain data, such
as calculations performed in connection with laboratory
analysis, are eliminated by computerization or other
automated processes.
In such instances a written record of the program shall be
maintained along with appropriate validation data.
Hard copy or alternative systems, such as duplicates, tapes,
or microfilm, designed to assure that backup data are exact
and complete and that it is secure from alteration, inadvertent
erasures, or loss shall be maintained.
32. Retention Period: §211.180
a) Any production, control, or distribution record that is
required to be maintained in compliance with this part and is
specifically associated with a batch of a drug product shall be
retained for at least 1 year after the expiration date of the
batch or, in the case of certain OTC drug products lacking
expiration dating because they meet the criteria for exemption
under § 211.137, 3 years after distribution of the batch.
(b) Records shall be maintained for all components, drug
product containers, closures, and labeling for at least 1 year
after the expiration date or, in the case of certain OTC drug
products lacking expiration dating because they meet the
criteria for exemption under § 211.137, 3 years after
distribution of the last lot of drug product incorporating the
component or using the container, closure, or labeling.
33. §211.68(b): Risk
Computerised Systems “Changes to
Records Made by Authorized Personnel”
Many firms use a help desk to co-ordinate
change requests for GXP systems
Help desk software needs to be validated: e-
records
Risk assessment: what is the impact on product
safety, efficacy and quality?
Direct?
Indirect?
34. Record Inspection: §211.180(c)
All records required under this part, or copies of
such records, shall be readily available for
authorized inspection during the retention period at
the establishment where the activities described in
such records occurred. These records or copies
thereof shall be subject to photocopying or other
means of reproduction as part of such inspection.
Records that can be immediately retrieved from
another location by computer or other electronic
means shall be considered as meeting the
requirements of this paragraph.
35. Record Archival: §211.180(d)
Records required under this part may be
retained either as original records or as true
copies such as photocopies, microfilm,
microfiche, or other accurate reproductions
of the original records. Where reduction
techniques, such as microfilming, are used,
suitable reader and photocopying
equipment shall be readily available.
36. 21 CFR Part 58 GLP
Subpart J—Records and Reports
§58.185 Reporting of Non-clinical Lab
Study Results
§58.190 Storage and Retrieval of
Records and Data
§58.195 Retention of Records
37. Raw Data
Definition of ER from Part 11
Broad scope
Predicate Rules Define Application to ER
Narrow scope
FDA Guidance to Clarify
Industry Coalition Seeks to Define “Raw
Data” as NOT Being ER
38. Raw Data: 21 CFR Part 58
FDA Says “Raw Data” Available for Inspection Requires
Integrity as Electronic Records
(k) Raw data means any laboratory worksheets, records,
memoranda, notes, or exact copies thereof, that are the result
of original observations and activities of a non-clinical
laboratory study and are necessary for the reconstruction and
evaluation of the report of that study.
In the event that exact transcripts of raw data have been
prepared (e.g., tapes which have been transcribed verbatim,
dated, and verified accurate by signature), the exact copy or
exact transcript may be substituted for the original source as
raw data.
Raw data may include photographs, microfilm or microfiche
copies, computer printouts, magnetic media, including dictated
observations, and recorded data from automated instruments.
39. Records Storage and Retrieval:
§58.190
(a) All raw data, documentation, protocols, final reports, and
specimens (except those specimens obtained from
mutagenicity tests and wet specimens of blood, urine, feces,
and biological fluids) generated as a result of a non-clinical
laboratory study shall be retained
(b) There shall be archives for orderly storage and expedient
retrieval of all raw data, documentation, protocols, specimens,
and interim and final reports. Conditions of storage shall
minimize deterioration of the documents or specimens in
accordance with the requirements for the time period of their
retention and the nature of the documents or specimens. A
testing facility may contract with commercial archives to
provide a repository for all material to be retained. Raw data
and specimens may be retained elsewhere provided that the
archives have specific reference to those other locations
(c) An individual shall be identified as responsible for the
archives
(d) Only authorized personnel shall enter the archives
(e) Material retained or referred to in the archives shall be
indexed to permit expedient retrieval
40. GLP Raw Data
Bottom Line:
Apply risk analysis to evaluate the
importance of ‘raw data’
Document how the data is being
controlled to ensure integrity based upon
its value to the integrity of the ER it
supports
i.e. Save data records in a normal manner
Save checksum of data records as ER
41. Equipment Design: §58.61
Equipment used in the generation, measurement, or
assessment of data …. shall be of appropriate design and
adequate capacity to function according to the protocol and
shall be suitability located for operation, inspection, cleaning
and maintenance
Note similar requirements for 21 CFR 211.63
Appropriate Design:
Write a user requirements specification
Adequate Capacity:
Design – liaison with IT and/or supplier
Incorporate in a design document or URS
Suitably Located:
Read and follow the supplier’s instructions
Documented evidence of installation (IQ/OQ)
42. 21 CFR Part 820 QSR
§820.180 – General Requirements
§820.181 – Device Master Record
§820.184 – Device History Record
§820.186 – Quality System Record
§820.198 – Complaint Files
43. 21 CFR Part 820 QSR
21 CFR Part 820 – Quality Systems
Regulation
Covers the use of computers in devices
§820.30 Design controls
§820.70 Production and Process Controls
Covers records for device development
Subpart M, §820.180 – 820.198
44. Automated Processes:
820.70(i)
When computers or automated data processing systems are used as part of
production or the quality system, the manufacturer shall validate computer
software for its intended use according to an established protocol.
All software changes shall be validated before approval and issuance.
These validation activities and results shall be documented
Wide Scope:
Systems for QMS and device production
Intended Use:
Write a user requirements specification
Established Protocol:
CSV policy, validation plan and testing scripts
Changes Approved:
Change control SOP & authorization signatures
45. Record Requirements:
§820.30(a)(1)
Each manufacturer of any Class III or Class
II device, and the Class I devices ….. shall
establish and maintain procedures to
control the design of the device in order to
ensure that specified design requirements
are met
If Electronic, Records within and About the Equipment
Must Meet Part 11 Requirements
46. Record Requirements:
§820.180(i)
When computers or automated data
processing systems are used as part
of production or the quality system, the
manufacturer shall validate computer
software for its intended use according
to an established protocol.
All software changes shall be validated
before approval and issuance
These validation activities and results
shall be documented
47. Record Retention Period :
§820.180(b)
All records required by this part shall
be retained for a period of time
equivalent to the design and expected
life of the device, but in no case less
than 2 years from the date of release
for commercial distribution by the
manufacturer.
48. Record Archival : §820.180
All records required by this part shall be maintained at the
manufacturing establishment or other location that is
reasonably accessible to responsible officials of the
manufacturer and to employees of FDA designated to perform
inspections.
Such records, including those not stored at the inspected
establishment, shall be made readily available for review and
copying by FDA employees.
Such records shall be legible and shall be stored to minimize
deterioration and to prevent loss
Those records stored in automated data processing systems
shall be backed up.
49. Summary
Predicate Rules Rule!!
You Must Be Familiar With What Records
and Signatures Are Required By the
Applicable Predicate Rules
Part 11 Is Triggered By
Predicate Rule Requirements
High Risk
Electronic Decision Making
Incorporate a Risk Analysis
Document Your Justification