The VA is interested in receiving input with regard to a potential requirement for services IAW the attached PWS to perform an audit of the Sustainment of Blood Bank Maintenance Project Quality System used to create and support medical device software thereby meeting Food and Drug Administration Title 21 CFR Part 11, 803, 806, 820, and 821 regulations. The vendor conducting the service must be a Certified Auditor with the International Register of Certificated Auditors (IRCA) or a Certified Quality Auditor with American Society for Quality (ASQ). The audit will include a desk audit of documentation and a site visit of two to three days for additional review, interviews, and discussion. The preferred audit window is June 11, 2018 to June 29, 2018 but must be completed no later than July 13, 2018.
Responses are due by May 22, 2018.
