VALIDATION AND SECURITY MEASURES FOR PHARMACEUTICAL DATA PROCESSING
About Authors:
Krunal Parikh1*, Maheshkumar Kataria2
1 M.Pharm, Quality Assurance,
2Assistant professor, Department of pharmaceutics,
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Krunal_2922@yahoo.in
ABSTRACT
The Quality System regulation requires that “when computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol.” This has been a regulatory requirement for GMP since 1978. In addition to the above validation requirement, computer systems that implement part of a regulated manufacturer’s production processes or quality system (or that are used to create and maintain records required by any other FDA regulation) are subject to the Electronic Records, Electronic Signatures regulation. This regulation establishes additional security, data integrity, and validation requirements when records are created or maintained electronically. These additional Part 11 requirements should be carefully considered and included in system requirements and software requirements for any automated record keeping systems.