Most clinical data integrity findings don't start with fraud. They start with unreviewed audit trails, late source entries, and records that don't match the EDC. For sponsors and CROs ...
Everything is going smoothly in your organization: SOPs are up-to-date, batches are well-documented, and all the activities within the QM system seem to be running in the proper way. ...
Preparation for regulatory inspections involves a lot of work. Documents are organized in the final weeks. Standard Operating Procedures (SOP) undergo a quick review. Training is performed again. The ...
There is an agreement among people who worked with a new drug product going through the approval process. The issue is not usually the science. The problem is caused ...
FDA issued over 50 warning letters in 2023 due to GMP violations which could easily be discovered with a reliable gmp audit service provider. A generic drugs maker in ...
Every manufacturer knows how the atmosphere is in the plant prior to a regulatory inspection. Floors are clean; logbooks are in order; and somebody in QA hopes the inspector ...
