Internal and External Pharmaceutical Audits
Internal and external audits are integral to your compliance strategy. External pharmaceutical audits ensure compliance with your vendor management program. Conducting regular internal audits maintains your obligation toward CAPA, continuous improvement and serves as a control to ensure compliance.
We partner with pharmaceutical companies to conduct internal and external audits and prepare remediation plans to guide you toward compliance or a satisfactory relationship with your vendors. We also work with you after an audit is performed to help monitor regulatory goals.
When conducting your pharmaceutical audits, we assess against agreed upon standards and regulations your:
- Written SOPs and processes
- Job descriptions and competence
- Documentation and validation
- Processes and records
- Facility management
- Quality control systems