21 CFR Part 11 Audit Prep

$250-750 AUD

Closed

Posted 28 days ago

$250-750 AUD

Paid on delivery

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.

Project ID: 40377762

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9 freelancers are bidding on average $558 AUD for this job

@saifsolutions

Hi there, I'm ready to start working on your project 21 CFR Part 11 Audit Prep. I’ve reviewed your description carefully, and as a creative & academic content writer with extensive experience in Technical Writing, I’m confident I can deliver a solution that meets your expectations and aligns with your vision. Check out my profile here: ✨ https://www.freelancer.com/u/saifsolutions ✨ Feel free to reach out via chat or Freelancer call so we can discuss your project in more detail. Best regards, Saifullah

$299 AUD in 2 days

5.0

(3 reviews)

5.3

@govindasamyjgces

Greetings, I am a Quality and Regulatory Engineer with 12+ years of experience in QSHE (Quality, Safety, Health, and Environment) and strong expertise in medical device quality management systems, regulatory documentation, and risk management. I currently work as a consultant for: ISO 13485 – Medical Device Quality Management Systems ISO 9001 – Quality Management Systems ISO 27001 – Information Security Management Systems (ISMS) I also have solid working knowledge and hands-on experience in: EU MDR 2017/745 FDA regulatory documentation expectations Risk Management – ISO 14971 Medical device technical documentation and IFU preparation Internal auditing and QMS gap assessment I have prepared IFU (Instructions for Use) and labeling documentation aligned with: ISO 20417 (Information supplied by manufacturer) ISO 15223-1 (Medical device symbols) USA FRDA 21 CFR Part 11 I have reviewed your requirement and I am confident that I can do preparation for 21 CFR Part 11 Audit. I would be happy to support this project. Please let me know if we can discuss further.

$900 AUD in 8 days

5.0

(21 reviews)

5.4

@jordanrafael7

Hi, I have 7+ years of experience supporting FDA-regulated environments, including hands-on work with 21 CFR Part 11 compliance for medical-device and software systems. I can help you finalize audit readiness quickly, focusing on gap identification, documentation refinement, and mock audit execution—without unnecessary consulting overhead. I focus on practical compliance—ensuring documentation, traceability, audit trails, and electronic signatures are defensible under FDA inspection. Timeline: 3–5 days (fast turnaround) If you’d like, I can start with a quick review of your current validation package and highlight immediate risks before the full engagement.

$500 AUD in 7 days

0.0

(0 reviews)

0.0

@JacobFeldman

Hello, I recently completed a similar project two months ago and successfully led the audit preparation for a medical-device company undergoing a 21 CFR Part 11 inspection. With over 4 years of experience in Audit, specializing in compliance for medical-device manufacturers, I am confident in my ability to guide your final stretch towards readiness. I understand your requirements and will meticulously review your validation records, identify gaps, provide actionable recommendations, conduct a mock audit, and deliver a prioritized findings report. Let's discuss further details in chat. Best regards

$420 AUD in 7 days

0.0

(0 reviews)

0.0

@michealh473

Hi, thank you for your job posting. I’m Micheal, and I have strong experience supporting regulated projects with structured documentation, validation review, and audit preparation workflows. I’ve worked with software/equipment validation packages, SOP development, and gap analysis aligned with compliance frameworks. For your 21 CFR Part 11 audit prep, I can systematically review your existing validation records (software, equipment, QMS), identify any gaps, and provide clear, prioritized remediation actions. I’ll help refine SOPs and protocols so they are concise, audit-ready, and aligned with Part 11 expectations. I can also run a focused mock audit, including staff interview coaching, to surface weak points and strengthen responses before inspection. You’ll receive a structured gap-analysis report, updated documentation, mock audit checklist with notes, and a final readiness statement referencing applicable CFR sections. I’m detail-oriented, fast-moving, and available to start immediately to meet tight timelines. Best regards, Micheal

$400 AUD in 3 days