Computer System Validation For Life Science Based Company

Our client is a prominent provider of data-driven quality analysis solutions, faced the imperative task of validating their file-sharing software in preparation for an impending compliance audit. The software demanded adherence to rigorous standards, including Gamp 5 certification, compliance with 21 CFR part 11, GXP regulation, and alignment with US FDA regulations. This validation process needed to be accomplished within a challenging timeline, compounded by the scarcity of comprehensive system information.

Testhouse responded with agility, assembling a dedicated team of Computer System Validation (CSV) engineers, led by a seasoned CSV consultant. Despite the initial dearth of system details, Testhouse adeptly crafted essential documents to initiate the validation process. This included the development of the User Requirements Specification (URS), System Categorization, Regulatory Assessment, and Risk Assessment, all achieved with minimal or no rework.

The subsequent phase involved executing a meticulous validation process, comprising Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). To ensure a thorough assessment, Testhouse prepared an extensive array of test case documents covering Functional, Non-Functional, Security, User Acceptance Testing (UAT) Regulatory, and Risk-related scenarios.

Throughout the validation process, the Testhouse team identified and documented defects, ensuring that the software met the highest standards of reliability. Each test was executed with precision, and evidence was promptly captured and shared. The culmination of these efforts resulted in the compilation of a comprehensive Validation Summary Report and Work Instruction Log, meeting the stringent timelines set for the impending audit.

Our client reaped substantial benefits from the collaborative effort with Testhouse:

• Achieved a flawless 100% on-time delivery, ensuring the software’s readiness for the impending compliance audit.
• Produced a total of 17 high-quality documents, rigorously reviewed and approved, with documentation defects amounting to less than 2%.
• Executed all tests within the specified timelines, meticulously recording results and providing comprehensive evidence to meet stringent audit requirements.
• Successfully identified and addressed potential gaps during the audit process, ensuring regulatory compliance.
• Received a glowing customer testimonial, acknowledging Testhouse as an exemplary champion in Computer System Validation, attesting to their commitment to quality.

This successful collaboration not only ensured immediate compliance but also positioned our client’ file-sharing software as a reliable and robust solution in a competitive market. Testhouse’s commitment to efficient and meticulous CSV processes not only met the immediate compliance needs but also set a high standard for future software validation endeavours with our customers.