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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