Appendix 5-FDA-CDRH Document Control Ceneter Tracking System Requirements

Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ Recompete Request for Proposal (RFP) No. 75F40126R00009
Attachment A: Statement of Work Appendices
Appendix 5: FDA/CDRH Document Control Center (DCC) Tracking System Requirements

FDA/CDRH Document Control Center (DCC)
Tracking System Requirements
Scope
The Contractor shall provide, configure, maintain, and support a Document Control Center (DCC) Tracking System that meets the requirements set forth in this section. The system shall support all document tracking, quality control, production monitoring, courier and destruction tracking, scanning and imaging, access control, automated alerting, system integration, SLA compliance monitoring, analytics, and disaster recovery functions required under this Task Order.

System Requirements
The following requirements define the minimum functional capabilities of the DCC Tracking System. The Contractor shall ensure all requirements are satisfied prior to system deployment and shall maintain compliance throughout the period of performance. Requirements are organized by functional area and shall be traceable to applicable Task Order deliverables, performance standards, and Acceptable Quality Levels (AQLs).

Note: If a cloud-based solution is proposed for this aspect of the requirement, it must be FedRAMP certified at the time of proposal in accordance with HHSAR clause 352.239-77 CLOUD COMPUTING

SERVICES (FEB 2024) (DEVIATION) [HHSAR CD 2024-01, Amendment

1 (Mar. 1, 2024)].
REQ-01 | Document Tracking & Workflow Management
The DCC Tracking System shall provide end-to-end tracking of every document through its full lifecycle, from initial receipt through final disposition. The system shall serve as the authoritative record of document location, status, and processing history at all times. The Contractor shall ensure the system supports same-day processing requirements and provides supervisors with real-time visibility into workflow status. At a minimum, the system shall:
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Log carrier tracking numbers, delivery date and time, and assign a unique internal tracking number upon receipt of each document or submission. Record real-time processor assignments and maintain an individual work queue for each staff member, displaying documents assigned, in-progress, and completed.

Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ Recompete Request for Proposal (RFP) No. 75F40126R00009
Attachment A: Statement of Work Appendices