Auditing

Audits are an essential quality tool for verifying compliance, vendor qualification, good practices (GxP) and progress of the product development plan. In addition, they are often the first step to developing an action plan in areas where "continuous improvement" or deficiencies already known to exist.

 

Pharmatrial has the experience to provide a wide scope of different audits covering all stages of the product development plan.

 

Pharmatrial audit procedures, audit reports and audit certificates are acceptable to all authorities and meet the requirements of all currently effective audit standards. All audit reports include recommendations for corrective actions.

 

At your request, Pharmatrial team can also help you prioritize the action items, develop a formal corrective actions plan and work with your staff or vendor to implement the recommendations.

Pharmatrial is working closely with other international consulting firms that provide audit services to assist their auditors on audits to be conducted in globally.

 

Among Pharmarial different audits:

  • GMP compliance audits for pharmaceuticals (APIs & finished drug products)

  • GMP/QSR  audits for Medical devices

  • Documentation audit to ensure it is appropriate for a regulatory inspection

  • GCP site audits

  • Investigator site file audit

  • Trial master file audits

  • CRO asassement audits

  • Clinical IT Systems and Data Management audit

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