21 CFR Part 11 Audit Prep
Budget: $250 – $750 AUD
I am gearing up for a 21 CFR Part 11 inspection in a medical-device environment and need an experienced compliance professional to guide the final stretch. The focus is audit preparation, not broad consultancy—we already have most of the groundwork in place but require an external eye to test, refine, and document readiness.
Scope
• Walk through existing validation records for our software systems, manufacturing equipment, and quality management system, confirming they align with Part 11 expectations.
• Identify any documentation gaps, recommend corrective actions, and help craft concise remediation plans.
• Conduct a mock audit, including interviewer coaching for key staff, to surface weak spots before FDA arrives.
• Supply a brief, prioritized findings report with clear pass/fail criteria and evidence references.
Deliverables (acceptance criteria)
1. Gap-analysis report covering software, equipment, and QMS validation—no open critical findings.
2. Updated or newly drafted SOPs / protocols where gaps are found, ready for immediate approval.
3. Mock audit checklist and completed session notes signed off by internal QA.
4. Final readiness statement confirming compliance posture with references to CFR text sections.
If you have a proven track record leading Part 11 audits for medical-device manufacturers—and can commit to a fast turnaround—let’s connect.
Scope
• Walk through existing validation records for our software systems, manufacturing equipment, and quality management system, confirming they align with Part 11 expectations.
• Identify any documentation gaps, recommend corrective actions, and help craft concise remediation plans.
• Conduct a mock audit, including interviewer coaching for key staff, to surface weak spots before FDA arrives.
• Supply a brief, prioritized findings report with clear pass/fail criteria and evidence references.
Deliverables (acceptance criteria)
1. Gap-analysis report covering software, equipment, and QMS validation—no open critical findings.
2. Updated or newly drafted SOPs / protocols where gaps are found, ready for immediate approval.
3. Mock audit checklist and completed session notes signed off by internal QA.
4. Final readiness statement confirming compliance posture with references to CFR text sections.
If you have a proven track record leading Part 11 audits for medical-device manufacturers—and can commit to a fast turnaround—let’s connect.