Computer System Validation (CSV)
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:
- ERP: Enterprise Resource Planning covering materials and resources.
- EDMS: Electronic documentation management systems.
- EBR: Electronic Batch Record.
- SCADA, DCS, etc.
- LIMS.
- Pharmacovigilance.
- Clinical trials.
- Laboratory instrumentation.
- CAPA systems.
- Computer systems qualification.
