VA RFQ: Compliance External Audit of VistA – Blood Establishment Computer Software (VBECS) Quality System

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).

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