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.
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.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
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 (CSV) is a core requirement for several industries. The aim of Computer System Validation is to ensure, through documentation, that the computer systems function the way they are intended to, consistently, repeatedly and reproducibly, somewhat in the manner expected of scientific experiments. So, the validation, meaning authentication or corroboration, is something that has to be done right from the start, that is, defining the computer system, to their use and going all the way right up to the time the computer system is retired.
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.
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.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
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 (CSV) is a core requirement for several industries. The aim of Computer System Validation is to ensure, through documentation, that the computer systems function the way they are intended to, consistently, repeatedly and reproducibly, somewhat in the manner expected of scientific experiments. So, the validation, meaning authentication or corroboration, is something that has to be done right from the start, that is, defining the computer system, to their use and going all the way right up to the time the computer system is retired.
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.
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 presentation is about the validation of software. It focus on the validation of software used in pharmacy. It contains definition of validation, computer system and validation of computer system. It explains the models which are used for software validation and on example i.e. HPLC software validation.
Computerized System Validation Business Intelligence SolutionsDigital-360
Executive Summary
Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation.
Agile Computer System Validation of software productsWolfgang Kuchinke
Personalized medicine seems to be a potential solution to the known challenges facing clinical research and drug development. To be employed in clinical research, software tools must undergo a process called Computer System Validation (CSV) for compliance with legal requirements and Good Clinical Practice (GCP). Four academic developer groups of the EU project p-medicine were surveyed to evaluate the readiness of their developed software products to be used for clinical research. The analysis of the survey showed that considerable gaps exist in tool maintenance, quality management and compliance documentation. Because all developer groups use agile development methods, recommendations for agile quality assurance were developed as well as for using agile methods to establish “compliance by design”. We show how agile validation can be established by small modifications of sprint processes.
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
Analytical Instrument Qualification forms the base for generating quality data. The USP chapter 1058 describes a scientific and risk-based approach to analytical instrument qualification. The 2017 revision is planned for publication on 1 December 2017.
Data Integrity app Link: https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity&hl=en
One Step Ahead in Pharma Compliance
Across the internet, there are millions of resources are available which provide information about Computer System Validation.
Refer above Data Integrity app which helps you to understand current regulatory agencies thinking on Data Integrity.
This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.
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 presentation is about the validation of software. It focus on the validation of software used in pharmacy. It contains definition of validation, computer system and validation of computer system. It explains the models which are used for software validation and on example i.e. HPLC software validation.
Computerized System Validation Business Intelligence SolutionsDigital-360
Executive Summary
Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation.
Agile Computer System Validation of software productsWolfgang Kuchinke
Personalized medicine seems to be a potential solution to the known challenges facing clinical research and drug development. To be employed in clinical research, software tools must undergo a process called Computer System Validation (CSV) for compliance with legal requirements and Good Clinical Practice (GCP). Four academic developer groups of the EU project p-medicine were surveyed to evaluate the readiness of their developed software products to be used for clinical research. The analysis of the survey showed that considerable gaps exist in tool maintenance, quality management and compliance documentation. Because all developer groups use agile development methods, recommendations for agile quality assurance were developed as well as for using agile methods to establish “compliance by design”. We show how agile validation can be established by small modifications of sprint processes.
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
Analytical Instrument Qualification forms the base for generating quality data. The USP chapter 1058 describes a scientific and risk-based approach to analytical instrument qualification. The 2017 revision is planned for publication on 1 December 2017.
Data Integrity app Link: https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity&hl=en
One Step Ahead in Pharma Compliance
Across the internet, there are millions of resources are available which provide information about Computer System Validation.
Refer above Data Integrity app which helps you to understand current regulatory agencies thinking on Data Integrity.
This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
Validation.
Validation is establishing documented evidence which provides a high degree of assurances that a specific process or equipment will consistently produce a product or result meeting its predetermined specifications and quality attributes”.
A system must be qualified to operate in a validated process
The results of analytical procedures should be:
— reliable
— accurate
— reproducible
The characteristics that should be considered during validation of analytical methods are:
— specificity
— linearity
— range
— accuracy
— precision
— detection limit
— quantitation limit
— robustness
computer system is a latest validation system in pharmaceutical industries.
To compliance with the good laboratory practice and good manufacturing practice.
it`s part of 211CFR part 11.
Computerized system validation (CSV) as a requirement for good manufacturing ...Ahmed Hasham
The biopharmaceutical industries has more and more used computers to support and accelrate producing of their
products. Computer systems also are accustomed support routine offer of high quality products to boost production
process performance, scale back production prices, and improve product quality. it's vital that these systems square
measure suitable purpose from a business and restrictive perspective. Regulatory authorities treat a lack of regulatory
computer system compliance as a serious GxP deviation.
validation is a technique of validating the final product either starting from the raw material or within the process, its all types cover the methods of validation and sequence in the product development.
validation is an important documentation protocol used in most of the laboratories and industries which is used for validation and evaluating different research protocols and equipment used in product formulation and development
Similar to Gamp Riskbased Approch To Validation (20)
2. Agenda
What is GAMP?
Terminologies
Validation Life Cycle as per GAMP-4 guidelines.
Risk Management.
3. GAMP History
Therac-25 Incident: the software for a large radiotherapy device was poorly designed and
tested In use, several interconnected problems lead to several devices giving doses of radiation
several thousands of times higher than intended, which resulted in the death of three patients
and several more being permanently injured.
In 1987 the Food and Drug Administration published a document entitled
‘FDA Guidelines on General Principles of Process Validation (See Title 21 Code of Federal
Regulations (CFR) Part 820, and 61 Federal Register (FR) 52602, respectively)’.
The Good Automated Manufacturing Practice (GAMP) Forum was founded in 1991 by
pharmaceutical industry professionals in the United Kingdom to address the industry's need to
improve comprehension and evolving expectations of regulatory agencies in Europe. The
organization also sought to promote understanding of how computer systems validation should
be conducted in the pharmaceutical industry.
In 1994, GAMP partnered with the International Society for Pharmaceutical Engineering (ISPE)
to publish the first GAMP guidelines. GAMP quickly became influential throughout Europe as
the quality of its work was recognized internationally. Over time, GAMP has become the
acknowledged expert body for addressing issues of computer system validation.
4. ISPE History
GAMP is a technical sub-committee, known as a COP (Community
Of Practice) of the International Society for Pharmaceutical
Engineering (ISPE).
ISPE, the International Society for Pharmaceutical Engineering, is
the world's largest not-for-profit association dedicated to educating
and advancing pharmaceutical manufacturing professionals and
their industry. Founded in 1980, today ISPE serves 25,000
members in 90 countries.
5. Why Validation???
Software validation is a requirement of the Quality System regulation, which was
published in the Federal Register on October 7, 1996 and took effect on June 1,
1997. (See Title 21 Code of Federal Regulations (CFR) Part 820, and 61 Federal
Register (FR) 52602, respectively.)
6. What is Validation?
Validation (FDA Definition) : Establishing documented evidence that provides a
high degree of assurance that a specific process will consistently produce a product
meeting its pre-determined specifications and quality attributes.
Validation (CDRH Definition) : An activity of confirmation by examination and
provision of objective evidence that software specifications conform to user needs
and intended uses, and that the particular requirements implemented through
software can be consistently fulfilled.
7. Terms used in validation
Prospective Validation: A process conducted before new items are released to make sure the
characteristics of the interests which are functional properly and which meet the safety
standards.
Retrospective Validation: A process for items that are already in use and distribution or
production. The validation is performed against the written specifications or predetermined
expectations, based upon their historical data/evidences that are documented/recorded. If any
critical data is missing, then the work can not be processed or can only be completed partially.
GxP: A general term for Good Practice quality guidelines and regulations, used in many fields,
including the pharmaceutical and food industries. The titles of these good practice guidelines
usually begin with "Good" and end in "Practice", with the specific practice descriptor in between.
GxP represents the abbreviations of these titles, where x (a common symbol for a variable)
represents the specific descriptor.
Change Request (CR): A formally submitted artifact that is used to track all stakeholder
requests (including new features, enhancement requests, defects, changed requirements, etc.)
along with related status information throughout the project lifecycle. All change history will be
maintained with the Change Request, including all state changes along with dates and reasons
for the change. This information will be available for any repeat reviews and for final closing.
8. Terms used in validation (Cont..)
Release Notes (RN): The release notes typically describe new
capabilities, known problems, and platform requirements necessary for
proper product operation.
Validation Plan (VP): Document determining the validation activates
along with approximate timings and responsibilities.
User Requirement Specification (URD/URS/SRS): The user
requirements specification will be used as the basis for the development of
the system acceptance test scripts / performance qualification test scripts
Functional Requirement Specification (FRD/FRS): A document that
describes in detail the characteristics of the product with regard to its
intended features. This document is the out come after one or more
reviews by the stakeholders on the project at hand after having negotiated
a cost-effective way to achieve the requirements the software needs to
fulfill.
9. Terms used in validation (Cont..)
Design Specification (DRD/DS/DDD/DDS): A System Design
Specification is created to define how the proposed system will
fulfill the GXP Computerized System's requirements.
Qualification: The process of determining whether a system or
component is suitable for operational use.
Installation Qualification (IQ): It is a document to verify that all
the components of a system installed as per the documented
specification.
Operational Qualification (OQ): It is a document to verify that
system operates as per the documented specification.
10. Terms used in validation (Cont..)
Performance Qualification (PQ): The Performance Qualification (PQ) ensures that
the total system performs as intended in the specified operating range. The total
system includes all hardware and software components, associated equipment,
people and procedures that make up the system. The execution process is
conducted using company specific pre-defined dataset or actual live data.
Traceability Matrix (TM): It is very important that direct traceability is established
between the specification and the test performed i.e. a cross reference from the test
script back to the section in the appropriate specification where the function is
defined. This traceability ensures that all parts of the software are tested, and
clearly establishes the acceptance criteria for a given test.
Validation Summary Report (VSR): It is very important that direct traceability is
established between the specification and the test performed i.e. a cross reference
from the test script back to the section in the appropriate specification where the
function is defined. This traceability ensures that all parts of the software are tested,
and clearly establishes the acceptance criteria for a given test.
11. Terms used in validation (Cont..)
Verification: is an activity to check are we building the product right?.
Validation: is an activity to check are we building the right product?
Testing: is the process to prove that the software works correctlyOne of the
verification activity that forms the part of validation process
Commissioning: Obtaining and documenting evidence that equipment has been
provided and installed in accordance with its specification and that it functions within
predetermined limits when operated in accordance with operational instruction.
Decommissioning: Decommissioning is a controlled process used to safely retire a
facility that is no longer needed
Supplier: A manufacturer who sells controlled products.
End Users: Customer (The individual or group who will use the system for its
intended operational use when it is deployed in its environment.)
12. Risk Analysis.
Risk assessment is defined as a
systematic activity that involves
identifying hazard and estimating
and evaluating risks.
Risk Management is the
systematic application of policies,
procedures and practices to the
tasks of analyzing, evaluating and
controlling risks
13. Types of Risk Analysis.
FMEA (Failure Mode and Effect Analysis)
FTA (Fault Tree Analysis)
HAZOP (Hazard and Operability Analysis)
HACCP (Hazard Analysis and Critical Control Point)
15. High Impact E-Records
Clinical and non-clinical studies (patient safety)
Compliant files (product quality)
Master production and control records (release decisions)
Patient information letters (usage instructions)
Component, drug product container, labeling records (enable
component traceability and product recall)
Batch records (production, product quality)
16. Medium Impact Records
Training/personnel records (indirect impact on product
quality/patient safety)
Financial disclosure by clinical investigations (GxP regulation)
Inspection records
Review and approval reports
SOPs that govern batch release
17. Low Impact Records
Planning documents
SOPs that govern validation of automated systems
Management information for validation or internal audits
18. Record Control Implementation
Procedural and technical controls for:
Security
Backup and restore
Disaster recovery
Audit trail
Record Copying
Record Retention
19. Backup and Restore
Formal process
Documented testing of process
Frequency
Backup verification
Storage conditions, locations and remote storage
Backup media refresh
20. Disaster Recovery
Formal process
Defined allowable time of outage
Recovery mechanisms
Documented testing of process
Defined recovery point
Ensuring error free operation
21. Audit Trail
Date/Time stamp
Time zone
Amount of information retained (who, what, when)
Access control and security of audit trail
Retention of audit trail
Backup and restore of audit trail
22. Category 1 (Operating System) validation as
per GAMP4
Commercially available operating systems which are used in
pharmaceutical operations are considered validated as part of any project
in which the application software operating on such platforms are part of
the validation process (i.e. the operating systems themselves are not
currently subjected to specific validation other than as part of particular
applications which run on them). Well known operating systems should be
used.
For validation record keeping, record the name and version number in the
hardware acceptance tests or equipment IQ.
New versions of operating systems should be reviewed prior to use and
consideration given to the impact of new, amended or removed features on
the application. This could lead to a formal re-testing of the application,
particularly where a major upgrade of the operating system has occurred.
E.g.: Unix, Windows etc
23. Category 2 (Firmware) validation as per
GAMP4.
Category 2 is Standard Instruments,
Micro Controllers and Smart
Instrumentation.
These are driven by non user
programmable firmware.
Examples: Weigh scales, bar code
scanners, 3 term controllers.
This type of software is configurable
and the configuration should be
recorded in the equipment IQ.
The unintended and undocumented
introduction of new versions of
firmware during maintenance must be
avoided through the application of
rigorous change control. The impact
of new versions on the validity of the
IQ documentation should be reviewed
and appropriate action taken.
24. Category 3 (Standard Software Package)
validation as per GAMP4.
Category 3 is Standard Software
Packages. These are called
Canned or COTS (Commercial
Off-The-Shelf) configurable
packages.
To satisfy the validation, user
requirement should be
documented, reviewed and tested
during OQ.
Supplier audit required for highly
critical and complex objects, SOP
should be established and
training plans should be
implimented.
E.g.: HPLC
25. Category 4 (Configurable Software Package)
validation as per GAMP4.
Category 4 is Configurable
Software Packages. These are
called custom configurable
package.
End user perform supplier audit to
ensure that the level of quality
and structural testing built into the
standard product. The audit
needs to consider the
development of the standard
product which may have followed
a prototyping methodology
without a customer being
involved.
E.g.: All Arisglobal system.
26. Category 5 (Configurable Software Package)
validation as per GAMP4.
Category 5 is Custom built or
bespoke systems.
Custom built or bespoke systems
should be validated using the full
system life cycle approach.
An audit of the supplier is
required to examine their existing
quality systems and a validation
plan should then be prepared to
document precisely what activities
are necessary, based on the
results of the audit and on the
complexity of the proposed
bespoke system.
27. Getting it right…
“Validation is nothing more than
well documented common sense”
Ken Chapman, 1985 – Chairman of Pharmaceutical
Manufacturer’s Association Computer Validation Committee
But remember :
“If it isn’t documented, it’s a rumour” !
Dr Ron Tetzlaff – Former FDA National Expert