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Abstract

COMPUTER SYSTEM VALIDATION: A REVIEW

Patil Yogesh* Mali Kamlesh, Bodhane Mohini, Ram Phad, Shaikh Ismail, Lale Shivam

ABSTRACT

Pharmaceutical industry regulatory compliance of computerized systems is of ever increasing importance. The regulations require specific record keeping on product safety, efficacy, strength, quality and purity. 21 CFR Part 210 and 211 and others apply to Pharmaceutical Products and 21 CFR Part 820 applies to Medical Devices. Life cycle include the stage of planning, specification, programing, testing, commissioning, documentation, operation, monitoring and modifying. The V-Model supports structured testing which is essential for successful validation. Qualification is the process of establishing appropriately documented verifications and tests that provide a high level of assurance that a computer system will operate in accordance with predefined specifications (DQ, IQ, OQ, PQ).

Keywords: Computer system validation, GMP, life cycle model.


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