Computerized System Validation
Computerized System Validation (CSV) verifies through documented activities that the computerized systems operate within its specification and acceptance criteria as defined and specified.
GMP Compliance of CSV
IT-Infrastructure is subject to validation regarding a GMP-related environment. CSV principles of validation of computerized systems include GMP regulations and requirements e.g. FDA 21 CFR Part 11, GAMP, EudraLex Vol. 4 Annex 11, EudraLex Vol. 4 Annex 15, Datatype, ALCOA+ principles, and a risk-based system classification.
About Computerized System Validation (CSV)
Validation of computerized systems should be risk-based throughout the entire system lifecycle. A cross-functional validation team should be formed and responsibilities such as System Owners, Qualified Persons, and Process Owners clarified.
Objective of CSV
Manufacturing facilities, analytical instruments, devices and utilities used for quality control, drug manufacturing or drug development are nowadays mostly combined with computerized systems.
User Requirement Specifications (URS)
System specifications and laboratory’s requirements should be specified in the User Requirements Specification (URS). Validation specifications and the associated acceptance criteria should be established on a risk basis.
Integrated Qualification and CSV
Analytical instrument qualification and process equipment qualification follow the integrated approach which combines qualification activities (DQ, IQ, OQ, PQ) and CSV. The purpose to combine CSV and system qualification is to save time and effort.
Data Integrity
Data integrity, data security, testing and validation have become key elements to CSV. IT experts need to collaborate with GMP experts and laboratory technicians.ALCOA+ Principles
ALCOA+ Principles
9 Principles govern Data Integrity:
ALCOA is the abbreviation for: Attributable, Legible, Contemporaneous, Original, and Accurate. This term was originated by the FDA and incorporated into the guidelines.
