Audits are an essential quality tool for verifying compliance and best practices and for measuring progress. They are also often the first step to developing an action plan in areas where “opportunities for improvement” are already known to exist – and a way to stay a step ahead in a highly regulated industry.

ABR’s standard practice is to conduct each audit with an eye to solutions. Our audits can be narrow in scope, examining a specific area or function, or a comprehensive assessment of your entire operation – based on your priorities and current business needs.

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After the inspection is complete, we generate a detailed written report and/or high-level written summary documenting our observations, gap analysis against relevant regulations, and recommendations for resolution of identified issues. At your request, we can also help you prioritize action items, develop a formal plan, and work with your staff or vendor to implement the recommendations.

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We offer the following audit services:

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• Comprehensive vendor, facility, and documentation quality audits

• Bioequivalence / Generic drug audits

• Independent QS Regulation and Good Manufacturing Practice (GMP) audits

• Good Laboratory Practice (GLP) audits

• Simulated pre-approval inspections

• Bioresearch Monitoring Audits (BIMO) and SMO/CRO audits for compliance to protocol and GCPs

• Combined QS Regulation / ISO 9000 Pre-Certification audits

• Design control audits

• Software quality audits

• Electronic Records/Electronic Signatures (21 CFR Part 11) compliance audits and action plans

• Internal audit and clinical audit training