Gap Analysis & Pre-Assessment Audit

Discover Gaps Before Inspectors Do

Agon’s Gap Analysis & Pre-Assessment Audit is your first line of defense against regulatory
surprises. We simulate real-world inspections to uncover hidden risks, non-conformities, and
documentation lapses—enabling your team to take corrective actions before authorities arrive.
Whether you’re preparing for WHO, EU GMP, USFDA, or local GMP audits, we help ensure that
your facility, processes, and records are audit-ready and inspection-proof.

What We Deliver

Comprehensive Gap Analysis

Facility-wide evaluation of systems, SOPs, documentation, and operations

Benchmarked against latest cGMP, WHO TRS, USFDA, and EMA guidelines

Prioritized list of critical, major, and minor gaps with root-cause mapping

Mock Regulatory Audits

Roleplay-based audits mirroring real inspector behavior and checklists

Interviews, document reviews, facility walkthroughs, and system testing

Final audit report and CAPA roadmap

Readiness Scorecard & Timeline

Quantified compliance scoring model for all departments

Timelines and resource allocation plans to address identified issues

Optional re-audit to confirm closure effectiveness

Why It Matters

Avoid last-minute fire drills before an inspection

Train your team with real audit scenarios

Establish internal accountability for compliance actions

Build confidence with documentation, hygiene, and traceability systems

Request a Pre-Audit Assessment

Contact

Macca Street. AI-Hussain Complex. Building 145, 1st Floor Amman, Jordan
+962 (79) 1533337
m.abuzour@agonme.com

Brochures

View our 2020 Medical prospectus of brochure for an easy to read guide on all of the services offer.

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Services

Management Representative

Training Programs

Gap Analysis & Pre-Assessment Audit