Audits

BlueReg understands the requirements of the health authorities concerning audits and what to expect. Thus, we can provide a complete audit preparation package which we can tailor to your needs, including:

 

  • Standard Operating Procedure (SOP) reviewing/writing
  • Pharmacovigilance System Master File (PSMF) reviewing/writing
  • Corrective Action Preventive Action (CAPA) review
  • Setting up/reviewing a Quality Management System (QMS)
  • Data review of relevant documentation/certification/procedures
  • Conducting audits of sites (internal/third party)
  • Conducting mock audits
  • Providing support on-site during the audit
  • Pre-audit training to staff

 

All these activities are carried out in full compliance with Good Clinical Practices, Good Manufacturing Practices, Good Vigilance Practices and local standards as applicable.

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