GAMP 5 Categories, V Model and 21 CFR Part 11, EU Annex 11

• 21 CFR (Code of Federal Regulations) Part 11 has defined by the US FDA regulations that set forth the criteria applies to electronic records and electronic signatures that persons create, modify, maintain, archive, retrieve, or transmit under any records or signature requirement set forth in the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or any FDA regulation
• Annex 11 is part of the European GMP Guidelines and defines the terms of reference for computerized systems software used by organizations in the pharmaceutical industry.

Queries?

• Any relation between GAMP 5 or v Model with 21 CFR Part 11?
• Both are the set of guidelines which are used to validate a computer-based software used in pharma manufacturing companies.
• The guidelines are predefined, and software should comply with the guidelines.
• GAMP talks about “the How” and the 21 CFR talks “the What” during the Validation of computer-based software for Pharma companies.
• GAMP is a methodology and 21 CFR are a regulation
• 21 CFR Part 11 is US FDA and Annex 11 is EU guidelines.
• A Company is delivering software to the banking sector they never heard of part 11 but when the Pharma customer wants them to map Part 11 requirements will the solution comply with them?
• Even if a company is delivering software to the banking sector, the solution will generally comply with part 11 requirements.
• In banking software’s there may not be the reference of Part 11, but the requirements of Part 11 will be met by the banking software’s
• A software company is following SDLC models from the past 8 years. For the first time, they are delivering a pharma software solution. When the customer team comes for an audit what software development methodologies they need to demonstrate to win the auditor.
• Whenever there is an audit of the customer need to explain the detailed procedure followed to develop software right from the beginning of User requirement gathering to the maintenance and support.
• Even if the company does not know the standard guidelines, we can map the existing followed procedure with the guidelines and standards to comply with client requirements.
• The company which comes to audit have a set of guidelines or criteria which the supplier should comply to pass the audit.
• The pharma companies investigate whether the software follows GAMP, or Part 11 or EU annexure 11.
• To win the auditor the company must have followed an SDLC Methodology with Proper Reviews and Tracking.
• A software company doesn’t want to follow the V model, still wanted to deliver pharma software (Quality Management Software, Document Management System, ANDA and DMF tracker etc.). Will this be acceptable to Pharma Company?

Acceptable if Software Company follows standard SDLC models and follows the Standards for developing and managing the code.