QA_NIAID_eQMS_eTMF_071519.pdf

Questions and Answers Electronic Quality Management System (eQMS) and Electronic Trial Master File (eTMF) for

National Institute of Allergy and Infectious Diseases (NIAID) Solicitation ID: RFQ-RML-75N93019Q00001

7/15/2019

1. Questions related to Attachment 1 (Statement of Work)

Q1a. (Section 1.0 & 5.0) In Sections 1 (Introduction and Objectives) and Section 5 (Deliverables/Delivery Schedule of the SOW), the Government requests a six month pilot, followed by a System Release Memo, ATO, and transition into production. In Appendix A, Section 3 (HHS Information Security and/or Physical Access Security), the Government requires an SA&A Package, System Security Plan (SSP), Security Assessment Plan/Report (SAP/SAR), and Plan of Actions and Milestones (POA&M) within 30 days of contract award. Will the Government clarify expectations as to the nature of the pilot (proof of concept vs.

production pilot) and the required timeline?

A1a. Sections 1 and 5 are correct. The Government expects to conduct a production-style pilot, not a proof-of-concept.

Q1b. (Section 4.1.2) In Section 4.1.2 item #3 states that the system must be accessible from within and external to the NIAID networks (external NIAID partners, CROs, and other contractors). Will the external users be able to access the system through a VPN to the NIAID network (private access) or will they gain access to the system through internet (public access)?

A1b. External users should be able to access the system through the public Internet.

Q1c. (Section 4.1.2) Is NIAID expecting to conduct the SOP/Policy document change management process in the eQMS and have the approved document published to a Content Management System (CMS)? Also, will the eQMS to CMS integration need to remove the superseded SOP/Policy from CMS users’ view? If so, will the Government please articulate which content management system(s) will be used?

A1c. NIAID expects to conduct SOP/Policy document change management processes in the eQMS. Once documents are approved, they may be published to other systems manually or via software integrations.

Q1d. (Section 4.1.2) Does NIAID require the Electronic Quality Management System to segregate data records between Divisions that will use the eQMS and eTMF?

A1d. Yes, per the SOW sections 4.1.2.2 and 5.1.4.2.a.