Notice ID: 36C10B24Q0324
The Contractor conducting the service must be a Certified Auditor with the IRCA or a Certified Quality Auditor with the ASQ. The Contractor shall perform the following:
- Conduct an audit of VBECS compliance with applicable FDA Title 21 CFR Part 11, 803, 806, 820, and 821 regulations.
- Review each element of the FDA regulated Quality System (QS) used by VBECS to create and support the VBECS medical device.
- Comment on the effectiveness, adequacy, and regulatory compliance of the VBECS QS. The contractor will point out any non-compliance and recommend strategies to bring the project into compliance.
- Review available records and confirm the information they contain through interviews, observations, and requests for additional information. Quality System records that may be reviewed for objective evidence include:
- Prior internal and external audit findings.
- Management reviews.
- Corrective action documentation.
- Change control documentation.
- IOPs and policies.
- Organizational charts.
- Team roles and responsibilities.
- Review materials being audited, methods used and findings identified with assigned team members daily.
- Hold a summation meeting, detailing audit findings, with the VA Project Manager (PM), appropriate VBECS team members, and the VBECS Compliance Officer.
- Present a written, preliminary report of audit findings to the PM or designee at the completion of the audit.
The Period of Performance shall be July 1, 2024 – June 30, 2027. Any work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO).