Rigorous development and validation process using GAMP4 - A de facto standard for FDA Applications

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Company Profile

Client is an established provider of mobile devices based software services pertaining to clinical trials.

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.

These aspects included:

• Functional requirements specifications
• Design specifications
• Documented evidence of unit and integration testing
• Documented evidence of code review
• Computer system validation plan
• 21 CFR part 11 check list / SOP Gap analysis
• Risk analysis
• Traceability matrix
• IQ/OQ/PQ testing protocols
• IQ/OQ/PQ test scripts
• IQ/OQ/PQ testing summary
• IQ/OQ/PQ deviation log
• Documented change control
• Documented source code including a manual to describing the content of each source code file
• Software user manual

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, 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 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 documentI
• Installation Qualification (IQ) document
• Operational Qualification (OQ) document
• Performance Qualification (PQ) document
• Validation Plan
• Code review sheet
• CFR checklist
• User Guide

Q3 interacted with many consultants who could show the right path toward complying with GAMP 4 guidelines, and acquired templates for the cluster of documents to be prepared.

In addition, Q3 conceived and realized the importance of keeping the documents at a centralized location and maintaining version control. A proper versioning control system was set up using Microsoft Visual Source Safe (VSS) and all documents including source code was stored there. Not only that, day-to-day processing of the documents was done using VSS, and Q3 was able to successfully perform versioning control, as wished by client.

Benefits

The benefits of complying with GAMP 4 guidelines included:

• Cost benefits that were achieved by aiding the production of systems that were fit for purpose, met the business requirements, and had acceptable operation and maintenance costs.
• Better visibility of projects to ensure delivery on time, on budget, and to agreed quality standards.
• Increased understanding of the subject and introduction of common terminology and format.
• Improved compliance with regulatory expectation by defining a common and comprehensive life cycle model.
• Clarification of the division of responsibility between user and supplier