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.
Get a Compliance Verification Audit
Compliance Standards
Here 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
However, our auditors are also 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
Our Approach to Compliance Verification Audits
Our audit experts follow the risk-based GxP principles laid out by PIC/S, ICH, EMA and the FDA, to prioritize the processes and systems to assess. We know which areas auditors are most likely to target and apply the following approach to assessing your systems and software validation procedures.
- Meet with you to discuss your products and markets to verify the scope of applicable audit standards.
- Plan an audit schedule that minimizes disruptions to your ongoing operations and customer service. For example, we can plan an audit schedule for completion as-soon-as possible or spread the audit activities over a few weeks.
- Conduct an audit to verify regulatory compliance via system demos, review of system and validation documentation and records, and interviews with your subject matter experts.
- Deliver an Audit Report, typically within 1 week.
- When the audit confirms regulatory compliance, we also provide an audit summary Certificate suitable for sharing with customers.
We can perform your audit either onsite or remotely – whichever fits your needs and budget.
