eTMF Inspection Readiness Checklist Creation

$30-250 USD

Closed

Posted about 1 month ago

$30-250 USD

Paid on delivery

We are looking for an experienced **eTMF / TMF / GCP QA specialist** to provide or develop a comprehensive **eTMF Inspection Readiness Audit Checklist** for clinical trial TMF review. An existing checklist is acceptable, provided it is editable, comprehensive, and suitable for sponsor/CRO inspection readiness use. ## Scope The checklist should cover, at minimum: * TMF Plan and governance * TMF Reference Model / artifact alignment * Study, country, and site-level completeness * Essential documents review * Document quality and legibility * Metadata accuracy * Filing timeliness * Version control and lifecycle status * Missing documents and placeholders * Audit trail and e-signature review * User access and permissions * Sponsor/CRO/vendor oversight * Monitoring, safety, regulatory, ethics, IP, training, and deviation records * TMF reconciliation and transfer * Archiving and retention readiness * Inspection access readiness * Risk-based sampling approach * Audit findings and action tracking ## Required Deliverable Please provide the checklist in **editable Excel or Word format** with fields such as: * Checklist item * Review area * Expected evidence * Acceptance criteria * Risk level * Result: Pass / Fail / Partial / N/A * Finding or observation * Required action * Responsible owner * Due date * Reviewer/date * Comments ## Preferred Freelancer Experience Experience with: * eTMF / TMF management * GCP QA audits * Inspection readiness * Sponsor or CRO oversight * CDISC TMF Reference Model * Veeva Vault eTMF or similar systems * FDA, EMA, MHRA, or ICH GCP expectations ## Proposal Requirements Please include: 1. Your TMF/eTMF experience 2. Whether you already have an available checklist 3. Sample or screenshot, if possible 4. Confirmation that the file is editable 5. Estimated delivery time 6. Any references or standards used ## Final Output Expectation The checklist should be practical, comprehensive, inspection-ready, and suitable for use by a sponsor, CRO, or QA auditor during eTMF inspection readiness review.

Audit

Research

Project ID: 40435275

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2 freelancers are bidding on average $85 USD for this job

@omair890

Hi there, I can provide a comprehensive, inspection ready eTMF/TMF Audit Checklist designed for sponsor, CRO, and QA audit use within your budget. I have experience supporting GCP quality documentation, TMF compliance reviews, and inspection readiness activities aligned with ICH GCP, FDA, EMA, MHRA, and CDISC TMF Reference Model expectations. The checklist will cover all requested areas including TMF governance, essential document completeness, metadata accuracy, audit trails, filing timeliness, vendor oversight, reconciliation, archiving readiness, CAPA tracking, and risk based sampling. I can deliver the checklist in a fully editable Excel or Word format with structured review fields such as acceptance criteria, risk rating, findings, corrective actions, reviewer tracking, and due dates for practical audit execution. I already have a strong foundational TMF audit framework that can be customized and expanded specifically for your inspection readiness requirements, including compatibility with systems such as Veeva Vault eTMF and similar platforms. The final deliverable will be professionally organized, easy to use during live audits, and suitable for both internal QA reviews and regulatory inspection preparation. I can also include sample sections or screenshots upon request and confirm that all files will remain fully editable for future sponsor or CRO customization. Delivery can be completed within the agreed timeline with revisions included if required.

$30 USD in 1 day

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@Mallik88

I am interested in supporting your requirement for an eTMF / TMF Inspection Readiness Audit Checklist. With 10+ years of experience in Quality Assurance, Computer System Validation (CSV), GxP compliance, and audit readiness within the pharmaceutical and healthcare industry, I have extensive experience supporting regulated documentation systems, inspection readiness activities, and quality/compliance reviews. My experience includes: • GxP, GCP, GMP, and 21 CFR Part 11 compliance • Inspection readiness and audit support • SOP review, deviation/CAPA management, and risk assessments • Sponsor/CRO oversight activities • Validation and compliance review of electronic systems • Documentation lifecycle management and audit trail review • Vendor management and quality governance I can deliver: • Fully editable Excel and/or Word format • Practical and inspection-ready structure • Alignment with ICH GCP, FDA, EMA, and TMF Reference Model expectations • Suitable for sponsor, CRO, or QA auditor use I can complete the deliverable within 3–5 business days depending on the level of detail required. I would be happy to further customize the checklist based on your preferred TMF structure, Veeva Vault eTMF workflow, or sponsor/CRO expectations. Thank you for your consideration. I look forward to the opportunity to support your project. Best Regards, Mallikarjuna Reddy D CSV & Quality Assurance Consultant

$140 USD in 7 days