Audits are an essential quality tool for verifying
compliance, good practices and progress. In
addition, they are often the first step to
developing an action plan in areas where
“opportunities for improvement” are already known to
exist.
AccuReg’s standard practice is to
conduct each audit with an eye to solutions. Our
audits are as broad and deep as the situation
warrants and your priorities dictate. After the
inspection is complete, we generate a detailed
written report or high-level written summary
documenting our observations. Again, the scope of
the report is dependent on your goals for the audit
and the format that best serves those goals. All
audit reports include recommendations to resolve
identified issues. At your request, we can also help
you prioritize the action items, develop a formal
plan and work with your staff or vendor to implement
the recommendations.
We Offer:
- Quality Systems Regulation compliance audits: 21
CFR 820 (Medical Devices)
- Good Manufacturing Practices (GMP) compliance
audits: 21 CFR 210/211 (Finished Pharmaceuticals)
- Electronic Records/Electronic Signatures
compliance audits: 21 CFR Part 11
- Biological
Products compliance audits: 21 CFR 600/610
- ISO 13485:2003 compliance audits
- Submissions compliance (Dossiers and Technical
Files) under the Medical Device Directive (MDD
93/42/EEC) and Directive for Active Implantable
Devices (90/385/EEC) per Change Directive
2007/47/EC.
- Recognized Third Party auditor for Quality
System certification under Consent Decree
requirements
- Biomedical research audits
- Simulated pre-approval inspections
- Clinical study, clinical site, and SMO/CRO
audits for compliance to protocol and Good
Clinical Practices
- Combined 820 ISO Pre-Certification audits
- Design control audits
- Software quality audits (can include
security and privacy compliance under Part 11
and HIPAA)
- Coming in Q3 2010: Sarbanes-Oxley auditing.
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