Our latest GMP Trends Report Issue #1157 highlights troubling patterns that underscore the ongoing need for robust controls over computerized systems. Data integrity remains a cornerstone of GMP compliance, yet recent findings in our reports continue to reveal serious lapses across the pharmaceutical and medical device industries.
A recurring theme within our report was the lack of proper audit trails and access controls. One firm used analytical equipment without audit trail functionality to assess whether drug batches met specifications. Alarming still, the firm had not even evaluated the risk this posed to data reliability and product quality.
In multiple cases found within the observations, software used to manage production, inventory, and laboratory data was found to be unvalidated—posing significant risk to data accuracy and security. Some systems lacked defined user privileges, with analysts sharing administrative-level logins. This allowed unfettered access to raw data, including the ability to alter time stamps—compromising traceability and accountability.
Additionally, several systems allowed users to delete data, with no procedural safeguards in place to monitor or restrict such actions. Walkthroughs revealed that both supervisors and managers retained full deletion capabilities on sensitive equipment like FT-IR and GC-MS systems.
Compounding these issues, some firms had not established or documented essential validation activities for inventory and quality record management software. Basic requirements such as Installation Qualification were not addressed.
These findings reflect a broader concern: data integrity is not just a technical issue—it’s a cultural one. Firms must prioritize system validation, user access control, and routine audit trail reviews. The integrity of data is foundational to ensuring product quality, patient safety, and regulatory compliance.
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