Q3 Technologies: GAMP4 for FDA Applications

Q3 Technologies, Gurgaon, India did a rigorous development and validation process using GAMP4 - A de facto standard for FDA Applications.

Business Situation:

Clinical trials are conducted according to set protocols formed by institutions, such as the Food and Drug Administration (FDA). Naturally, client needs to comply with the FDA protocols, and consequently the software needs to follow other industry standard protocols for computer systems.

Client not only required its prospective vendor to deliver the right software product, but also the entire documentation as specified in Good Automated Management Practices 4 (GAMP 4) guidelines. Client was very specific about the documentation requirements and provided the entire list of SDLC aspects that need to be considered by the documents while complying with GAMP 4 guidelines.

Solution:

In the IT industry, documenting each and every SDLC process is universally considered as a good practice, but is seldom achieved in real-life. A major reason could be the fact that in the trade-off between quality software and quality documentation, it is always the latter one that has to lose the battle mostly because of the stringent deadlines and partly due to its second fiddle status. However, initial interaction with the client suggested that it was as much concerned about the documentation requirements as with the functional requirements of the software.

Though, for Q3 Technologies, positioning the quality of software and associated documents on the same platform was a big challenge, it had belief in its abilities; and this belief required support in the form of some detailed research on GAMP 4 guidelines. Once research was completed, Q3 Technologies mapped the findings with the client requirements and came up with a list of 10 documents that would eventually and convincingly cover all the aspects listed by client. The documents included:

• Risk Analysis document
• Functional Requirements Specifications (FRS) document
• Software Design Specifications (SDS) document
• Software Development Kit (SDK) document
• Unit Test Cases document
• Release notes document
• Installation Qualification (IQ) document
• Operational Qualification (OQ) document
• Performance Qualification (PQ) document
• Validation Plan
• Code review sheet
• CFR checklist
• User Guide