Recent observation for Computer control : Master BMR soft copy was controlled by production

"WHAT IF -Series#1"

Revolutionizing Regulatory Oversight: The Potential of AI-Driven Audits in the Pharmaceutical Industry The U.S.

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"WHAT IF -Series#1"

Revolutionizing Regulatory Oversight: The Potential of AI-Driven Audits in the Pharmaceutical Industry The U.S.

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FDA Exposes Record Deletion & Falsified Data in Pharma Plant: A Crisis of Trust and Compliance – Recent 483 observation for IT systems.

In the pharmaceutical industry, compliance with Good Manufacturing Practices (GMP) is not just a regulatory requirement…

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Recent Observation for IT system controls

?? Lack of Access Controls , ????? Unauthorized Admin Rights, ?? Traceability Gap, ?? Inadequate Backups, ?? Software…

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Recent observation on IT system controls

Is that companies are not serious about data integrity or users are not trained enough on Data integrity. Yes, recently…

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Recent IT GxP 483 and It's CAPA "SUGGESTION"

Hope all the beloved members in the group are safe and healthy at this pandemic situation. Dear Reader's, SME's , GxP…

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Recent observation on Computer controls

Administrative privileges assigned to analyst. Deletion of Test results and aborted sample set results .

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Observation Related to Audit trail: Failed to review audit trail periodically

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Observation for Failure to Restrict "Recycle bin & Desktop D Drive"

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Observation for Failure to Restrict "Recycle bin & Desktop D Drive"

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