Quality and Regulatory Sourcebook March 2022
Read the article:
Contextualizing Computer Validation
Read the eBook:
Pharmaceutical Technology's Quality and Regulatory Sourcebook eBook
Experts weigh in on the current state of computer validation and its role in the greater regulatory landscape.
Cybrain - Stock.adobe.com
Computer system validation (CSV), also known as software validation, is required by regulatory agencies throughout the development timeline. Pharmaceutical Technology reached out to various experts associated with the FDA-Industry Computer Software Assurance (FISCA) team to discuss computer validation and add context to the ongoing discussion surrounding its use and importance in the greater regulatory landscape.
Read this article in Pharmaceutical Technology's March 2022 Quality and Regulatory Sourcebook eBook.
Read the article:
Contextualizing Computer Validation
Read the eBook:
Pharmaceutical Technology's Quality and Regulatory Sourcebook eBook
About the author
Grant Playter is the Assistant Editor for Pharmaceutical Technology, BioPharm International, and Pharmaceutical Technology Europe.
Article Details
Pharmaceutical Technology eBook: Quality and Regulatory Sourcebook, March 2022 Pages: 16-18
Citation
When referring to this article, please cite it as G. Playter, “Contextualizing Computer Validation," Pharmaceutical Technology's Quality and Regulatory Sourcebook eBook (March 2022).
Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.