Regulatory inspections are not scheduled events — they are the result of continuous audit readiness. Affinity QMS Audit Management keeps your internal audit program running year-round, your suppliers qualified on schedule, and your organization ready for FDA, ISO, or SQF auditors at any time.
Pre-Built Audit Checklists — Ready to Use on Day One
Audit Schedule Management
Build an annual internal audit plan that covers every quality system element required by your regulatory framework. The rolling calendar view shows upcoming audits, assigned auditors, and completion status. Automated reminders go to audit leads before scheduled dates — preventing the common finding of an incomplete annual audit program.
Checklist Library for Every Vertical and Standard
Pre-built audit checklists for 21 CFR Part 820, ISO 13485, 21 CFR Part 211, 21 CFR Part 111, ISO/IEC 17025, SQF, BRCGS, and FSMA/HARPC. Each checklist maps audit questions to specific regulation clauses. Checklists are editable — add organization-specific questions without losing the regulatory mapping.
Audit Finding and Observation Tracking
Record audit findings (nonconformances requiring corrective action) and observations (opportunities for improvement) during or after an audit. Each finding is classified by type, severity, and regulatory reference. Finding status is tracked through response, correction, and closure — creating a complete audit resolution record.
CAPA Linkage from Finding to Corrective Action
Audit findings that require corrective action generate linked CAPAs in one click. The finding, CAPA, and closure are cross-referenced. When FDA or ISO auditors return, they can see that every prior finding has a documented corrective action — demonstrating a functioning quality system, not just a paper one.
Supplier Audit Management with Scoring
Schedule and conduct supplier audits with vertical-specific supplier audit checklists. Score each supplier on quality system elements — documentation, CAPA, production controls, and regulatory compliance. Supplier audit scores feed into the Approved Vendor List qualification status and annual re-qualification decisions in Supplier Management.
Mock FDA Inspection Mode
Run a self-inspection using FDA's actual inspection protocols — organized by 21 CFR Part 820 subpart, ISO 13485 clause, or FSMA element. Mock inspection findings generate internal CAPAs to close gaps before a real inspection. The mock inspection record itself demonstrates to FDA that your organization conducts systematic self-assessment.
Audit Report Generation
Generate a complete audit report — audit scope, checklist responses, findings, observations, and response requirements — with one click. Reports are formatted for presentation to management and for regulatory file maintenance. Audit reports are archived with the audit record and accessible at any time for inspection or certification review.
| Regulation / Standard | Clause / Section | Audit Management Coverage |
|---|---|---|
| 21 CFR Part 820.22 | Quality Audit | Annual audit plan, qualified auditors, audit reports, CAPA linkage from findings |
| ISO 13485:2016 | Clause 8.2.4 — Internal Audit | Audit program, criteria, frequency, methods, reporting, and records |
| ISO/IEC 17025:2017 | Clause 8.8 — Internal Audits | Audit planning, implementation, reporting of findings, corrective action |
| SQF Code | 2.5 — Food Safety and Quality Management System | Internal audit schedule, findings, corrective actions, senior management review |
| BRCGS | Clause 3.4 — Internal Audits | Audit frequency by risk, qualified auditors, finding closeout within defined timeframes |
| FDA QMSR (2024) | 820.22 — Quality Audit | Audit procedures, reporting, corrective action documentation |
| 21 CFR Part 111 | Subpart B — Personnel | Personnel qualification audits, training verification, facility inspections |
Included in Builder — Starting at
$799/mo
Audit Management is included in the Builder tier ($799/mo) and all tiers above it. Pre-built checklists for all verticals, supplier audit scoring, and mock FDA inspection mode are included — no add-ons required.
Book a demo and see how Affinity QMS Audit Management keeps your internal audit program running year-round — with pre-built checklists, mock FDA inspection mode, and CAPA linkage built in.