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.
Additional information is available on specific types of validation: (CLICK LINK)
- ⇒ Validation Master Plans (VMP)
- ⇒Validation Plans (VP)
- ⇒Risk Assessment (RA)
- ⇒User Requirement Specifications (User Specs, URS)
- ⇒Functional Requirements (Functional Requirement Specifications, Functional Specs, FRS, FS)
- ⇒Design Specification (DS)
- ⇒Test Plan / Test Protocol
- ⇒Installation Qualification (IQ)
- ⇒Operational Qualification (OQ)
- ⇒Performance Qualification (PQ)
- ⇒Requirements Traceability Matrix (Trace Matrix, RTM, TM)
- ⇒Protocol Test Deviations
- ⇒Validation Summary Report (Validation Report, Summary Report, VR, SR)
- ⇒Change Control for Validated Systems
- ⇒Validation Terminology
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