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Our gap assessments are less formal, taking a broader view, and often are used as the first step in developing an action plan

for known areas of concern or for discovering new areas where “opportunities for improvement” exist. Our audits place greater focus on specific areas – often, those identified by Gap Assessment – and are key to developing a comprehensive, prioritized Quality Plan. Audits can take an informational, instructional approach; can introduce the client team to a simulated Agency inspection experience (as in the case of SIMFAs); or can combine the approaches (we call this “hats on/hats off”), becoming a comprehensive informational session for management and training experience for participating staff.


Whether it’s an audit or a gap assessment, AccuReg’s standard practice is to conduct each activity with an eye to S4 solutions, combined with a practical flexibility to ensure the review is only as broad and deep as the situation warrants and the client’s priorities dictate. Our wide range of Gap Assessment and Audit Services include:

  • 21 CFR Manufacturing/Quality Audits and/or Gap Analyses

    • Ethical pharmaceutical and OTC GMPs as per 21 CFR 210/211

    • Medical device Quality System regulations as per 21 CFR 820

    • Biologic GMPs as per 21 CFR 600-680, as applicable

    • HCT/Ps GMPs as per (21 CFR 1270-1271)

These Audits/Gap Analyses can be mock pre-approval inspections, mock-FDA audits, replacements for internal audits, etc.

  • Comprehensive vendor / supplier audits

  • Bioequivalence / generic drug audits

  • Biosimilar comparison audits

  • Medical device design control audits

  • Medical device ISO 13485 audits by ISO-certified auditors

  • Combined QS Regulation / ISO 9000 / ICH Pre-Certification audits

  • Clinical study, pre-BIMO, clinical site, and SMO/CRO audits for compliance to protocol and GCPs

  • Software quality audits /Electronic Records/Electronic Signatures audits and action plans

  • Pre-investment Due Diligence Audits.

After the gap assessment or audit is complete, our reviewers generate a detailed written report or high-level written summary (as per the client’s preference) documenting our observations. Again, the scope of the report is dependent on the client’s goals for the activity and the format that best serves those goals. All audit reports include recommendations (either verbal or written, per the client’s preference) for corrective actions. At the client’s request, we can also apply our Full Circle Prioritized Remediation Program which includes a gap assessment or audit, a formal risk-based prioritization of the observations, root cause determination for all high-priority observations, and solution development for all high-likelihood root causes using formal industry standards, best practices, and Six-Sigma quality tools.


Call, email or reach out through social media for a confidential discussion of how our team can best support yours. 





Although some use the terms "audit" and "gap assessment" interchangeably, in truth, the differences

between these activities are real - and purpose-driven.

AccuReg S4 Compliance Process
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