The Food and Drug Administration has sought information on potential industry sources that can provide a commercial off-the-shelf software platform designed to help FDA compile audits and assessments as well as detect and monitor preventive and corrective actions.
FDA said in a FedBizOpps notice posted Friday the proposed Quality Management Information System should be designed to capture and monitor product non-conformance, implement industry best practices and store standard operating procedures, among other requirements.
The agency requires interested vendors to submit a product accessibility template the details information on the operating system, internet and intranet and documentation support.
Potential contractors should also share their experience in agile development, deployment of COTS-based software platform for quality management and delivery of support to quality management software users.
Responses to the sources sought notice are due July 11, according to the notice.