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Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records is a critical requirement of electronic record compliance, as described in the FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4.
Our computer system validation experts have validated computer programs for all types of FDA-regulated businesses, including pharmaceutical and biologics manufacturers, medical device manufacturers, clinical research organizations, and GLP laboratories.
Ofni Systems has given computer validation presentations and training classes to organizations like FOI Services, ISPE, IVT, and PDA.
Additional computer system validation guidance and resources from Ofni Systems
Computer validation is more than a compliance requirement. Pharmaceutical computer system validation is a unique opportunity for a business to examine their computer systems to maximize effectiveness and enhance quality. Ofni Systems ensures that your validation project clearly documents why your customers should share the high degree of confidence you hold in your company and your systems, while scaling the project to your organizational validation requirements and budget.