A mid-sized biopharma company engaged Pharmatech to remediate an acquired Quality Management System after a gap assessment flagged weaknesses in design controls, risk management, and vendor oversight. We rewrote core SOPs, embedded risk-based principles, and strengthened Design History File governance.
Impact for the client:
- Acquired quality system integrated into the client’s QMS
- Design control and risk management SOPs made implementation-ready
- Purchasing controls and vendor oversight formalized
- DHF traceability strengthened for inspection readiness
