Excel spreadsheets how to ensure 21 cfr part 11 compliance
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Learn to create a GxP compliant Excel spreadsheet application. Understand how to validate Excel spreadsheets with minimal documentation. Learn to configure Excel for audit trails, security features, and data entry verification.
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21 CFR PART 11
21 CFR Part 11 outlines FDA regulations for electronic records and electronic signatures. It requires that electronic records be trustworthy, reliable, and equivalent to paper records. It also requires that electronic signatures be equivalent to handwritten signatures. The document then outlines the key subparts and sections of 21 CFR Part 11, including requirements for controls on closed and open systems, electronic signature components and controls, and validation of electronic records and signatures.
Gamp Riskbased Approch To Validation
This document provides an overview of GAMP (Good Automated Manufacturing Practice) guidelines for validation of computer systems used in regulated industries. It discusses the history of GAMP, key terms and concepts in validation like validation life cycle, risk management, categories of software. It also summarizes the validation requirements for different categories of software and records as per GAMP-4 guidelines. The document emphasizes that validation is important to ensure computer systems consistently produce intended results and meet safety standards.
computer system validation
Computer system validation is use in the pharma-companies to regular checking of their computers for better working...
Computer System Validation - The Validation Master Plan
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.
ANNUAL PRODUCT REVIEW
In this slide contains definition, importance, benefits of annual product review.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).
RIPER, anantapur.
cGMP Vs GMP presentation
The document discusses Good Manufacturing Practices (GMP) guidelines according to ICH Q7A. It states that both GMP and cGMP aim to prevent bad quality products from entering the market. GMP applies to pharmaceutical and healthcare products, while cGMP refers to using the most up-to-date production processes and technologies to comply with regulations, as defined by the FDA. Regulatory agencies that establish GMP standards are mentioned, along with the objectives of GMP and specific guidelines covering quality management, personnel, facilities, equipment, documentation, and production records.
Gamp 5 overview by jaya prakash ra
GAMP 5 provides a framework for validating computerized systems used in regulated industries. It recommends a life cycle approach involving quality risk management throughout planning, development, validation and operation. Key activities for regulated companies include governance, identifying systems' impact, and ensuring compliance. Suppliers play an important role by providing documentation, testing systems, and supporting changes and maintenance. The level of validation should be based on a system's risk, complexity and novelty.
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
The use of animals in research is currently an essential component of the drug discovery process.
Animals help us advance our scientific understanding, serve as models to study disease, help us develop and test potential new medicines and therapies.
Animal testing has benefited researchers in understanding how to treat and prevent various conditions such as high blood pressure, diabetes, tuberculosis, polio, muscular dystrophy, and Parkinson's disease.
Education:
Undergraduate teaching to demonstrate effects of various drugs although this has been phased out in most institutes.
Postgraduate teaching to demonstrate the effects of various drugs, to determine the nature of an unknown drug for bioassay, screening methods and to learn skills e.g. administering drugs.
Research:
A larger number and a greater variety of animals are used in pure research than in applied research. This usually involves studies on embryogenesis, developmental biology, behaviour and breeding in Fruit flies, nematodes, mice and rats.
INTRODUCTION
The motto of Prevention of Cruelty to Animals (PCA) Act 1960 as amended in 1982 is to prevent infliction of unnecessary pain or suffering on animals.
The Central Government has constituted a Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), which is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them.
The goal of these guidelines is to promote the human care of animal used in biomedical and behavioural research and testing.
To avoid/minimize pain and suffering inflicted on experimental animals
Inspection of animal house facilities
It provides guidelines for -
Proper care, housing, breeding, maintenance, handling and use of experimental animals.
Source of experimental animals
Acceptable experimental procedures for anaesthesia and euthanasia.
Registration of establishments conducting animal experimentation or breeding of animals for this purpose.
Selection and assignment of nominees for the Institutional Animal Ethics Committees (IAEC) of the registered establishments.
Approval of Animal House Facilities on the basis of reports of inspections conducted by CPCSEA.
Permission for conducting experiments involving use of animals.
Recommendation for import of animals for use in experiments.
Action against establishments in case of established violation of any legal norm/stipulation.
Conduct of Training Programmes for the Nominees of CPCSEA.
Conduct/Support of Conference/Workshop on Animal Ethics.
To assure quality maintenance and safety of animals used in laboratory studies while conducting biomedical and behavioural research and testing of products.
Quarantine
2. Personal hygiene
3. Environment
4. Physical facility
5. Animal husbandry
6. Animal disposal
7. Documentation
Recommended
21 CFR PART 11
21 CFR Part 11 outlines FDA regulations for electronic records and electronic signatures. It requires that electronic records be trustworthy, reliable, and equivalent to paper records. It also requires that electronic signatures be equivalent to handwritten signatures. The document then outlines the key subparts and sections of 21 CFR Part 11, including requirements for controls on closed and open systems, electronic signature components and controls, and validation of electronic records and signatures.
Gamp Riskbased Approch To Validation
This document provides an overview of GAMP (Good Automated Manufacturing Practice) guidelines for validation of computer systems used in regulated industries. It discusses the history of GAMP, key terms and concepts in validation like validation life cycle, risk management, categories of software. It also summarizes the validation requirements for different categories of software and records as per GAMP-4 guidelines. The document emphasizes that validation is important to ensure computer systems consistently produce intended results and meet safety standards.
computer system validation
Computer system validation is use in the pharma-companies to regular checking of their computers for better working...
Computer System Validation - The Validation Master Plan
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.
ANNUAL PRODUCT REVIEW
In this slide contains definition, importance, benefits of annual product review.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).
RIPER, anantapur.
cGMP Vs GMP presentation
The document discusses Good Manufacturing Practices (GMP) guidelines according to ICH Q7A. It states that both GMP and cGMP aim to prevent bad quality products from entering the market. GMP applies to pharmaceutical and healthcare products, while cGMP refers to using the most up-to-date production processes and technologies to comply with regulations, as defined by the FDA. Regulatory agencies that establish GMP standards are mentioned, along with the objectives of GMP and specific guidelines covering quality management, personnel, facilities, equipment, documentation, and production records.
Gamp 5 overview by jaya prakash ra
GAMP 5 provides a framework for validating computerized systems used in regulated industries. It recommends a life cycle approach involving quality risk management throughout planning, development, validation and operation. Key activities for regulated companies include governance, identifying systems' impact, and ensuring compliance. Suppliers play an important role by providing documentation, testing systems, and supporting changes and maintenance. The level of validation should be based on a system's risk, complexity and novelty.
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
The use of animals in research is currently an essential component of the drug discovery process.
Animals help us advance our scientific understanding, serve as models to study disease, help us develop and test potential new medicines and therapies.
Animal testing has benefited researchers in understanding how to treat and prevent various conditions such as high blood pressure, diabetes, tuberculosis, polio, muscular dystrophy, and Parkinson's disease.
Education:
Undergraduate teaching to demonstrate effects of various drugs although this has been phased out in most institutes.
Postgraduate teaching to demonstrate the effects of various drugs, to determine the nature of an unknown drug for bioassay, screening methods and to learn skills e.g. administering drugs.
Research:
A larger number and a greater variety of animals are used in pure research than in applied research. This usually involves studies on embryogenesis, developmental biology, behaviour and breeding in Fruit flies, nematodes, mice and rats.
INTRODUCTION
The motto of Prevention of Cruelty to Animals (PCA) Act 1960 as amended in 1982 is to prevent infliction of unnecessary pain or suffering on animals.
The Central Government has constituted a Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), which is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them.
The goal of these guidelines is to promote the human care of animal used in biomedical and behavioural research and testing.
To avoid/minimize pain and suffering inflicted on experimental animals
Inspection of animal house facilities
It provides guidelines for -
Proper care, housing, breeding, maintenance, handling and use of experimental animals.
Source of experimental animals
Acceptable experimental procedures for anaesthesia and euthanasia.
Registration of establishments conducting animal experimentation or breeding of animals for this purpose.
Selection and assignment of nominees for the Institutional Animal Ethics Committees (IAEC) of the registered establishments.
Approval of Animal House Facilities on the basis of reports of inspections conducted by CPCSEA.
Permission for conducting experiments involving use of animals.
Recommendation for import of animals for use in experiments.
Action against establishments in case of established violation of any legal norm/stipulation.
Conduct of Training Programmes for the Nominees of CPCSEA.
Conduct/Support of Conference/Workshop on Animal Ethics.
To assure quality maintenance and safety of animals used in laboratory studies while conducting biomedical and behavioural research and testing of products.
Quarantine
2. Personal hygiene
3. Environment
4. Physical facility
5. Animal husbandry
6. Animal disposal
7. Documentation
Computerized System Validation-basics
This document provides definitions and information related to computer system validation (CSV) concepts in the pharmaceutical industry. It defines key terms like CSV, data integrity, GxP compliance, regulations, guidelines, directives, and regulatory bodies. These include the US FDA, CDSCO, EMA, PIC/S, ICH, and WHO. The document also explains concepts such as regulatory affairs, computerized systems, validation, verification, qualification, and documentation like the user requirements specification and validation plan. It provides high-level overviews of documentation standards, processes, and quality practices for pharmaceutical computer systems.
Computer System Validation
An overview of Computer System Validation and why it is important when developing systems for pharmaceutical and healthcare industries.
Overview of computer system validation
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
BPR review and batch release
The document discusses batch production record (BPR) review and release. It defines key terms like deviations, critical process parameters, critical quality attributes. It outlines regulatory requirements from ICH Q7, CFR 211, and consequences of non-compliance. The objectives of BPR review are to confirm the batch quality and was produced under control. Records of critical steps must be reviewed and approved by quality before release. Failure to comply with cGMPs can render a drug adulterated under the FDA act.
Apr and PQR
The document provides guidance on conducting Annual Product Reviews (APRs), including:
- APRs are required annually for commercial products to verify consistency, assess trends, determine specification/process changes, and evaluate revalidation needs.
- APRs must include review of batches manufactured, deviations, complaints, recalls, changes, specifications, validation status, and trend analyses. Additional requirements may apply from local regulations.
- The review concludes if the product consistently meets quality attributes and necessary corrective actions. APRs communicate between manufacturing, quality, and regulatory to enable quality improvement.
FDA 483 observations in the lab
Real life FDA 483 observations in the lab that you should avoid. If you have a FDA Inspection scheduled, this presentation is for you.
New PICS Guidance on Data Integrity and Management.
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Understanding 21 cfr part 11
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
Introduction to GxP
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. These slides provide an overview of current regulations, with a focus on pharmaceuticals and healthcare.
CSV - Computer System Validation
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
Computer System Validation
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.
FDA PreApproval Inspection - Part 1
This document provides guidance on preparing for an FDA pre-approval inspection. It discusses what to expect during an inspection, including that inspectors will review documentation for compliance with quality standards. It stresses the importance of managing the inspection through preparation, including conducting internal audits and training personnel. It also recommends designating an inspection team to guide the process and handle document requests. The overall goal is to demonstrate control over quality issues to avoid delays in approval.
Good Automated Manufacturing Practices
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,
GLP 21 CFR part 58
This document discusses Good Laboratory Practices (GLP), which are regulations created by the FDA in 1978 to ensure quality and integrity in nonclinical laboratory studies. It establishes standards for laboratory organization and management, personnel, facilities, equipment, testing operations, and recordkeeping. Key aspects include requiring standard operating procedures, designated study directors, quality assurance units to conduct inspections, maintaining facilities and equipment, ensuring personnel qualifications, and properly housing, caring for, and identifying laboratory animals. GLP aims to eliminate fraudulent activities and poor practices identified in investigations of laboratories in the 1970s.
21 CFR part 11 Overview
There are several versions of 21 CFR Part 11 Overview, hope this is very consolidated and easily understandable for all of you. Thanks
Computer system validation review article by-mahesh 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.
Pharma data integrity
The document discusses data integrity and recent regulatory approaches. It defines data integrity as the completeness, consistency, and accuracy of data throughout its lifecycle. Regulatory agencies are increasingly focused on data integrity due to its importance in ensuring product quality and safety. Common data integrity issues found by agencies include fabricated, falsified, or missing records. Ensuring data integrity requires effective quality management systems, risk management, technology solutions, and governance.
Glp seminar
The document discusses the MOD, which is an abbreviation that stands for Ministry of Defence in the United Kingdom. The MOD is responsible for implementing the defence policy set by Her Majesty's Government and the defence of the UK and overseas territories. It is the largest government department, employing over 100,000 full-time personnel and is responsible for defence policy, procurement, and the Armed Forces of the UK.
21 cfr part 11 an approach towards compliance
This document provides an overview of 21 CFR Part 11, which establishes criteria for electronic records and electronic signatures. It discusses the history and meaning of 21 CFR Part 11, key requirements including validation, electronic signatures, controls for closed and open systems. It also defines important terminology, compares 21 CFR Part 11 to Annexure 11, and discusses applicability and the electronic data lifecycle. The document is intended to help organizations understand and comply with 21 CFR Part 11 requirements.
TQM GMP
Quality assurance and good manufacturing practices are important to ensure drug quality and safety. Quality assurance covers all factors that influence a product's quality and requires adequate resources. Good manufacturing practices provide quality standards for production and controls to ensure products meet their intended use as required by regulations. Key elements of good manufacturing practices include facilities, equipment, documentation, materials management, production controls, packaging and labeling, storage, and validation. While GMPs vary between countries, the overall goals are similar in requiring design and maintenance standards, standard operating procedures, quality control, trained personnel, and management oversight.
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This document provides definitions and information related to computer system validation (CSV) concepts in the pharmaceutical industry. It defines key terms like CSV, data integrity, GxP compliance, regulations, guidelines, directives, and regulatory bodies. These include the US FDA, CDSCO, EMA, PIC/S, ICH, and WHO. The document also explains concepts such as regulatory affairs, computerized systems, validation, verification, qualification, and documentation like the user requirements specification and validation plan. It provides high-level overviews of documentation standards, processes, and quality practices for pharmaceutical computer systems.
Computer System Validation
An overview of Computer System Validation and why it is important when developing systems for pharmaceutical and healthcare industries.
Overview of computer system validation
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
BPR review and batch release
The document discusses batch production record (BPR) review and release. It defines key terms like deviations, critical process parameters, critical quality attributes. It outlines regulatory requirements from ICH Q7, CFR 211, and consequences of non-compliance. The objectives of BPR review are to confirm the batch quality and was produced under control. Records of critical steps must be reviewed and approved by quality before release. Failure to comply with cGMPs can render a drug adulterated under the FDA act.
Apr and PQR
The document provides guidance on conducting Annual Product Reviews (APRs), including:
- APRs are required annually for commercial products to verify consistency, assess trends, determine specification/process changes, and evaluate revalidation needs.
- APRs must include review of batches manufactured, deviations, complaints, recalls, changes, specifications, validation status, and trend analyses. Additional requirements may apply from local regulations.
- The review concludes if the product consistently meets quality attributes and necessary corrective actions. APRs communicate between manufacturing, quality, and regulatory to enable quality improvement.
FDA 483 observations in the lab
Real life FDA 483 observations in the lab that you should avoid. If you have a FDA Inspection scheduled, this presentation is for you.
New PICS Guidance on Data Integrity and Management.
This presentation give a detailed overview of the PICS draft guidance on Data Integrity and Management.
Understanding 21 cfr part 11
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
Introduction to GxP
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. These slides provide an overview of current regulations, with a focus on pharmaceuticals and healthcare.
CSV - Computer System Validation
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
Computer System Validation
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.
FDA PreApproval Inspection - Part 1
This document provides guidance on preparing for an FDA pre-approval inspection. It discusses what to expect during an inspection, including that inspectors will review documentation for compliance with quality standards. It stresses the importance of managing the inspection through preparation, including conducting internal audits and training personnel. It also recommends designating an inspection team to guide the process and handle document requests. The overall goal is to demonstrate control over quality issues to avoid delays in approval.
Good Automated Manufacturing Practices
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,
GLP 21 CFR part 58
This document discusses Good Laboratory Practices (GLP), which are regulations created by the FDA in 1978 to ensure quality and integrity in nonclinical laboratory studies. It establishes standards for laboratory organization and management, personnel, facilities, equipment, testing operations, and recordkeeping. Key aspects include requiring standard operating procedures, designated study directors, quality assurance units to conduct inspections, maintaining facilities and equipment, ensuring personnel qualifications, and properly housing, caring for, and identifying laboratory animals. GLP aims to eliminate fraudulent activities and poor practices identified in investigations of laboratories in the 1970s.
21 CFR part 11 Overview
There are several versions of 21 CFR Part 11 Overview, hope this is very consolidated and easily understandable for all of you. Thanks
Computer system validation review article by-mahesh 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.
Pharma data integrity
The document discusses data integrity and recent regulatory approaches. It defines data integrity as the completeness, consistency, and accuracy of data throughout its lifecycle. Regulatory agencies are increasingly focused on data integrity due to its importance in ensuring product quality and safety. Common data integrity issues found by agencies include fabricated, falsified, or missing records. Ensuring data integrity requires effective quality management systems, risk management, technology solutions, and governance.
Glp seminar
The document discusses the MOD, which is an abbreviation that stands for Ministry of Defence in the United Kingdom. The MOD is responsible for implementing the defence policy set by Her Majesty's Government and the defence of the UK and overseas territories. It is the largest government department, employing over 100,000 full-time personnel and is responsible for defence policy, procurement, and the Armed Forces of the UK.
21 cfr part 11 an approach towards compliance
This document provides an overview of 21 CFR Part 11, which establishes criteria for electronic records and electronic signatures. It discusses the history and meaning of 21 CFR Part 11, key requirements including validation, electronic signatures, controls for closed and open systems. It also defines important terminology, compares 21 CFR Part 11 to Annexure 11, and discusses applicability and the electronic data lifecycle. The document is intended to help organizations understand and comply with 21 CFR Part 11 requirements.
TQM GMP
Quality assurance and good manufacturing practices are important to ensure drug quality and safety. Quality assurance covers all factors that influence a product's quality and requires adequate resources. Good manufacturing practices provide quality standards for production and controls to ensure products meet their intended use as required by regulations. Key elements of good manufacturing practices include facilities, equipment, documentation, materials management, production controls, packaging and labeling, storage, and validation. While GMPs vary between countries, the overall goals are similar in requiring design and maintenance standards, standard operating procedures, quality control, trained personnel, and management oversight.
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On Tuesday, December 6, 2016, our colleague Angelo Rossi, Senior Regulatory Compliance Consultant, gave an interesting presentation about “Data Integrity in a GxP-regulated Environment” at the Brussels Office of Pauwels Consulting in Diegem.
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Please contact us at contact@pauwelsconsulting.com or +32 9 324 70 80 if you have any further questions regarding our consulting services in this area.
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21 CFR Part 11 Compliance
Gain the latest insight (2013) into 21 CFR Part 11 Compliance from AITalent's latest Webinar.
Discover:
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Presentation on data integrity in Pharmaceutical Industry
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences - Rebuilding Trust
- Conclusion
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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.
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Streamline data accuracy checks with XLValidator, our advanced Excel validation tool. Detect errors, prevent discrepancies, and enhance spreadsheet reliability. Try it now! For more information, please visit - https://part11solutions.com/excel-validation-tool/
#ExcelValidation
Computerized system validation
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2) 21 CFR Part 11 provides regulations for computer systems used in clinical trials. It focuses on electronic records, signatures and controls to ensure accuracy, reliability and protect human health.
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Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.
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Presentation given at the ShareFest conference, Philadelphi - April 8th 2010.
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as:
G: Stands for good
x: Variable
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visit : https://www.agaramtech.com/
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The document provides an overview of a webinar on spreadsheet validation presented by Xybion Corporation. The webinar discusses common rumors around spreadsheet validation requirements, clarifies the regulatory realities, and outlines the risks of not properly validating spreadsheets used for regulated activities. The presenter explains that while spreadsheets are widely used, regulations still require their validation for intended use to ensure business continuity and data accuracy. Not validating poses risks of regulatory compliance issues. Available software can help address typical spreadsheet deficiencies in security and audit trails.
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- 1. Excel Spreadsheets -How to Ensure 21 CFR Part 11 Compliance?
- 2. What are Spread- sheets? Spreadsheets are a repository for critical data, and for making critical decisions. In Microsoft Excel, the workbook is the file that the user creates. Each worksheet contains - calculations, data entry fields, audit trail, and display formats that comprise the application.
- 3. FDA Expectations for Use of Spreadsheets All spreadsheets containing GxP or quality data must be compliant with 21 CFR 11 and the data within must be controlled. 21 CFR 11.10: Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity & when appropriate, the confidentiality of electronic records, and to ensure the signer cannot readily repudiate the signed record as not genuine. FDA has stepped up 21 CFR 11 enforcement since late 2010.
- 4. 21 CFR Part 11 RequirementsValidation Devicechecks Operationalsystemchecks Accurateandcomplete copies Accurateandsteady retrieval Limitedaccesstosystems anddata Authoritychecks Electronicaudittrail Training/qualificationof personnel Accountabilityof signatures Controloversystem documentation
- 5. Which Spreadsheets should be Compliant? Spreadsheets that control GxP data Clinical: Research Data, Result Data etc Laboratory: Lab Data, Animal Data etc Manufacturing Data Spreadsheets used to make quality decisions Documented evidence of SOPs Tracking Logs: Internal Audits, Approved Supplier Lists, Approved Batches, etc. QA: Quality Assurance Data Spreadsheet containing data that will be reported to a Regulatory Agency Even if it does not fit the previous 2 requirements Risk based approaches apply
- 6. Best Practices to Comply with FDA Requirements Develop, communicate and enforce a company policy and master plan for spreadsheet calculations. Prepare an inventory list with all computers that run spreadsheets. Standardize “development and use” as much as possible. Protect spreadsheets using built-in standard software and IT infrastructure (e.g., client/server). Validate spreadsheet calculations. Document and justify your approach.
- 7. Want to learn more about 21 CFR Part 11, its requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links: • Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance • Design and Validation of Excel Spreadsheets: Step-by-Step • Learning from Recent FDA Warning Letters Related to Part 11 • Understanding and Implementing FDA'S 21 CFR Part 11 • How to Comply with 21 CFR Part 11 Requirements for Electronic Medical Records • Computerized System Validation - A Detailed Insight • 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection • Complying with 21CFR Part 11-Understanding the Role of Predicate Rules