Compliance Verification Audits
If your customers require independent verification of compliance with key regulations such as Part 11 and Annex 11, our certified auditors can audit your systems, processes, and records to provide an objective certification of compliance.
Compliance Verification Audits
If your customers require independent verification of compliance with key regulations such as Part 11 and Annex 11, our certified auditors can audit your systems, processes, and records to provide an objective certification of compliance.A successful, independent compliance verification can assure your customers that your company’s products and services are suitable for their GxP needs.
Compliance Standards
Our auditors are experienced with standards from countries such as the UK, Canada, Australia, and Japan, as well as standard from organizations such as WHO, ICH, MHRA, ISO, AOPO, CAP, COLA, and ASHI. Below are our most frequently requested compliance verification standards:
FDA 21 CFR 11 Electronic Records; Electronic Signatures
Eudralex Annex 11 Computerised Systems
FDA General Principles of Software Validation.
ISPE GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems
Our Compliance Verification Audits Methodology
Our audit experts follow risk-based GxP principles outlined by PIC/S, ICH, EMA, and the FDA to prioritize the processes and systems to assess. We understand where auditors focus and apply a structured, efficient approach to evaluating your systems and software validation procedures.
Our Approach Includes:
- Scope Alignment
Meet with your team to understand your products and markets and confirm the scope of applicable audit standards. - Audit Planning
Develop an audit schedule that minimizes disruption to your operations and customer commitments. This can be executed on an accelerated timeline or phased over several weeks, depending on your needs. - Audit Execution
Conduct a thorough audit to verify regulatory compliance through:
• System demonstrations
• Review of system and validation documentation and records
• Interviews with subject matter experts - Audit Reporting
Deliver a comprehensive Audit Report, typically within one week of audit completion. - Certification
When compliance is confirmed, provide an audit summary certificate suitable for sharing with customers. - Flexible Delivery
Perform audits onsite or remotely based on your preferences, timeline, and budget.