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 ...
Clinical software systems can be installed, configured, and implemented in daily use without ever having gone through validation. This is the gap GCP auditing services are designed to find. ...
Having reviewed documents for sponsors, CROs, and investigator sites for eight years, I've noticed something constant. The people who deal with the data often know about the issues. They ...
Finding: "Documentation did not accurately reflect actual site practice." Six words. These six words mean months of remediation, a late submission, and sponsors wondering how no one saw this ...
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. ...
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 ...
