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Audits: Good Practices and Compliance

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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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