Computer System Validation CSV in Data Integrity Implementation Strategies for Pharmaceutical Industry

Abstract

Computer System Validation CSV in Data Integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). Due to the rise in cGMP violations involving data integrity during regulatory inspections, there have been issuances of many warning letter, import alerts and consent decrees. Electronic signature and record-keeping requirements as mentioned in 21 CFR Part 11 and apply to certain records, subject to records requirements set forth in Agency regulations, including parts 210, 211 and 212. Further, regulations for Computer System Validation CSV in data integrity issues occur mostly in quality laboratories and production areas and the causes vary due to personnel, equipment and management. The implementation of regulatory guidelines and standard operating procedures for data integrity, regular internal audits or surveillances and training will pave way for pharmaceutical industries to maintain Computer System Validation CSV in data integrity flawlessly. Key Terms - ALCOA, cGMP Violations, CSV, Electronic Signature, Regulations, Training, Warning Letters