Category: CSV/CSA

Data integrity demands a great amount of attention in the life science industry. This is now truer than ever with increased focus from the FDA, EU, and industry standards on data integrity issues and best practices. Audit trails for computerized systems are required for all FDA / EU regulated systems. It must capture the creation, […]

Data integrityIn a recently posted warning letter a number of issues were identified concerning data integrity of laboratory results.  These results included:Laboratory personnel used a software function “inhibit integration” without scientific justification. As identified in the warning letter: Inhibiting integration at various points during release testing for commercial batches is not scientifically justified. It can mask identification […]

Regulatory compliance activities, such as Computer System Validation (CSV), can often be burdensome and challenging if they are approached without risk assessment. Often CSV deliverable completion is driven by procedures that are not designed to account for risk in relation to system, requirement, and processes. It tends to be a process focused more on documentation […]

In a review of the latest one hundred (100) FDA Warning Letters issued as of May 17, 2019, nineteen (19) included the section header “CGMP Consultants Recommended” within the content of the letter, followed by these statements:  “Based upon the nature of the violations we identified at your firm, we strongly recommend engaging consultants qualified as set forth […]

Data integrity demands a great amount of attention in the life science industry. This is now truer than ever with increased focus from the FDA, EU, and industry standards on data integrity issues and best practices. Audit trails for computerized systems are required for all FDA / EU regulated systems. It must capture the creation, […]

In the world of commissioning, qualification, and validation for life science companies our world its pretty simple – you make a regulated product, you qualify the facility, the equipment, you validate the manufacturing process, and do change controls as necessary for equipment, facility, or process changes with updates to FDA  depending on the magnitude of […]

For compounding pharmacies regulated under section 503B, electronic record data integrity concerns are increasing in regulatory and customer visibility. The concepts of good data integrity practices is not new. Yet an organization can inadvertently open itself up to serious problems with their electronic record integrity if proper operating and computer system validation procedures are not […]

For compounding pharmacies regulated under section 503B, electronic record data integrity concerns are increasing in regulatory and customer visibility. The concepts of good data integrity practices is not new. Yet an organization can inadvertently open itself up to serious problems with their electronic record integrity if proper operating and computer system validation procedures are not […]

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter to a Japanese bio-chemical manufacturing company.  The Warning Letter summarized significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).  The letter cited non-compliance with section 501(a)(2)(B) of the 21 U.S.C. 351(a)(2)(B). The FDA inspection observed many data integrity non-compliances included retesting and manipulation […]