Audit Plan for Technical Files

Audit Plan for Technical Files

Client Name:    Auditor Name:

WHEREAS

WHEREAS, Client Name: is responsible for maintaining technical files supporting regulated products and requires an independent audit of selected technical documentation to verify completeness and compliance with applicable regulatory and internal standards; and

WHEREAS, Auditor Name: has the requisite technical and regulatory expertise to perform the audit in accordance with the scope and methodology set forth in this Audit Plan;

NOW, THEREFORE, the parties agree that the audit will be conducted under the terms and conditions set forth in this Audit Plan for Technical Files.

Definitions

For purposes of this Audit Plan, "Technical Files" means the documented evidence that demonstrates conformity of a product to applicable requirements, including design documentation, risk management files, verification and validation reports, clinical evidence, labeling, and post-market surveillance records.

Scope of Work

Included document types (check all that apply): Design dossier / technical file Risk management file Verification & validation Clinical evidence / post-market data

Audit Objectives and Criteria

Objectives: Verify that the selected Technical Files are complete, accurate, and demonstrate conformity to applicable regulatory requirements and the Client's internal procedures; identify nonconformities and opportunities for corrective action.

Methodology

Sampling Plan

Schedule and Logistics

Proposed on-site or remote audit start date:    Proposed completion date:

Deliverables

Final audit report to be issued within days of audit closing meeting.

Report format: PDF Excel Word

Nonconformities and Corrective Action

Nonconformity classification: Major Minor Observation

Standard corrective action response time for Major nonconformities:

Payment Terms

Late payment fee:

Term and Termination

Agreement effective date:    Agreement end date (if applicable):

Either party may terminate this engagement for material breach by the other party if the breach is not cured within days after receipt of written notice. Termination for convenience by either party requires days' prior written notice.

Confidentiality

The Auditor will treat all Technical Files and related information designated as confidential by the Client as Confidential Information and will not disclose such information except as required by law or with the Client's prior written consent. Confidential Information shall be used solely for the performance of the audit and associated reporting.

Confidentiality obligation duration (years):

Records and Retention

Audit records, working papers, and final reports will be retained by the Auditor for years, unless otherwise required by applicable law or agreed in writing.

Conflict of Interest

The Auditor certifies that, to the best of its knowledge, no conflicts of interest exist that would impair impartiality. If a potential conflict arises, the Auditor shall notify the Client immediately and propose mitigation measures.

Governing Law

This Audit Plan and any disputes arising from it shall be governed by the laws of:

Entire Agreement

This Audit Plan constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior discussions, proposals, or agreements related to the audit of the Technical Files. Any amendment must be in writing and signed by authorized representatives of both parties.

Key Contacts

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