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.”