Why Computer System Validation?

Production processes, lab equipment & system, ERP systems, Quality systems etc. that are being managed or supported by a computer system have to comply with strict rules with regards to continuity, reliability and data integrity. Computer system validation provides producers of pharmaceutical products with documented proof that the computerized / automated system performs consistently and in compliance with all regulations involved. Valical delivers CSV advice and support to companies in Pharma sector.

Automated production processes are being managed or controlled by a PLC or computerized system. Validation of these systems is crucial part of the system development life cycle (SDLC). If not validated, deviations (between the business or regulatory requirements and the delivered solution) might arise in a later project phase. Validation delivers a documented proof that the system complies with the specifications during the entire life cycle.

USFDA 21 CFR part 210, 211 and 11 and EU GMP annex 11 describes the requirement for computerized system in pharma production processes. This regulations apply to every computerized system that generates data that is used to support quality decisions or that is used to report to FDA. GAMP5 serves as a guideline to execute CSV in a through and structured manner. GAMP stands for Good Automated Manufacturing Processes and offers a series of procedures and principles which allows companies that produce pharmaceutical products to assure quality levels in a continued way. This is possible by validating all phases in the production process. It goes from screening of raw materials to the training of operators and it includes of course the validation of the software and equipment used.