The validation of computer systems, considered as a medical device or management software, is an industrial necessity and an area of principal interest during inspections and audits.
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.
System validation projects are always carried out by applying a GAMP methodology (Good Automated Manufacturing Practice); internationally recognized as a point of reference to be followed.
Here are some of the types of systems validated following our methodology: