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Audits - BlueReg Group

Audits

BlueReg Group Pharmacovigilance Audits

Audits

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

 

  • SOP reviewing/writing
  • PSMF reviewing/writing 
  • CAPA review
  • Setting up/reviewing a Quality Management System (QMS)
  • 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 Vigilance Practices and local standards.”

Blue Ocean Strategy Top-down and bottom-up design

Organisations & Systems

Safety reports

QPPV

Routine Pharmacovigilance activities