The Pharmaceutical Industry is subject to GMP regulations in which CSV is part of System Qualification.
About CSV?
Computerized System Validation (CSV) verifies that the computerized systems operate within its specification and acceptance criteria as defined and specified.
Data Integrity and 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.
Methods and Principles
About Computerized System Validation (CSV)
- Manufacturing facilities, analytical instruments, devices and utilities used for quality control, drug manufacturing or drug development are these days mostly combined with computerized systems. A computerized system (CS) describes a hardware with software combined applications. According to GAMP 5, the software is categorized into groups to determine the scope of validation.
GMP Compliance with CSV
- IT-Infrastructure is subject to validation regarding a GMP-related environment. CSV principles include GMP regulations e.g. FDA 21 CFR Part 11, GAMP 5, EudraLex Vol. 4 Annex 11, EudraLex Vol. 4 Annex 15, Datatype, ALCOA+ principles, and a risk-based system classification. CSV verifies that computerized system functions reliably and satisfying regulatory GMP requirements throughout the system lifecycle.
User Requirement Specification (URS)
- User requirements, system specifications and laboratory needs should be specified in the User Requirements Specification (URS). Validation specifications and the associated acceptance criteria should be established on a risk basis.
Software Categories
- Due to a variety of software applications, from firmware, infrastructure software, non-configured and configured products to custom applications, the software is classified. According to GAMP 5, the software is categorized into groups to determine the scope of validation.
Integrated Qualification
- Instrument and process equipment qualification follow an integrated approach which combines the qualification phases (DQ, IQ, OQ, PQ) into CSV. The purpose to combine CSV and system qualification is to save time and effort.
Summary
Validation of computerized systems should be risk-based and 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.