Solicitation-Amendment_HT942726RE0050001_Attachment_Q-and-A_2026.06.18.pdf

No. Vendor Question Government Response Relevant Solicitation Reference/Language Solicitation Revision (if applicable) 1 a. For which Regions will you prepare eCTD submissions? (US-only or other regions as well?)

b. Do you have a need to create non-eCTD submissions? (NeeS, eCopy, etc.)

c. Do you have a need to restrict access among users?

a. The Government has a requirement to prepare eCTD submissions for the US (Reference PWS, Part 7, Paragraph 7). The ability to prepare submissions for the EU is a possibility in the future but not relevant to the subject solicitation/requirement and should not be proposed.

b. Currently submissions are created manually. The Government does not have a requirement to create eCopy submissions at this time. This is a possibility in the future, however, it is not relevant to the subject solicitation/requirement and should not be proposed.

c. The Government has a requirement to restrict access to submissions between different organizations. Each organization may have multiple users (Reference PWS, Part 6, Paragraphs 6.11.3 and 6.11.5).

a. PWS, Part 7, Para. 7: "In addition, the system shall have the ability to automate workflow steps required to manage preparation of electronic submissions for submission to regulatory agencies (e.g., FDA)."

b. None.

c. PWS, Part 6: "6.11.3 Upon approval, DHA will notify the user of the ID and password via secure/encrypted e-mail upon the establishment of a user account. User accounts will be established for individual use and may not be shared by multiple users or for system generated access to any DoW application. Misuse of user accounts by individuals or Contractor entities will result in termination of system access for the individual user account."

"6.11.5 The Contractor shall provide the DHA DPCLO with a report of the findings of their review by the 10th calendar day of each month following the review. Reports identifying changes to Contractor employee access requirements shall include the name, DoW ID number from CAC, Company, IS/network for which access is no longer required, and the date access will be terminated."

a. PWS, Part 7, Para. 7. "In addition, the system shall have the ability to automate workflow steps required to manage preparation of electronic submissions for submission to regulatory agencies (e.g., FDA) in the US only."

b. No change.

c. No change.

2 Do you have a need to connect your Publishing software to any external systems?

The Government requires connection to external systems for accessing source documents. The current external systems that will be connected are OpenText Content Server and Network File Shares; the Government prefers to host our application on DHA servers (Reference PWS, Part 7, Para. 7).

"• Integrate the eCTD publishing system with other key DHA systems (e.g., Open Text – Content Server).

• The eCTD software shall be capable of interfacing with OpenText Content Server 22.4 and current releases. The eCTD software must support Microsoft Windows Server 2019 R2 (64-bit) operating system and newer. This is a designated go, no-go requirement under RFP Technical Approach."

No change.

3 Would you prefer to host our application yourself or do you prefer a vendor-hosted deployment?

The Government prefers to host our application on DHA servers (Reference PWS, Part 7, Para. 7). A vendor hosted FEDRAMP approved environment is also acceptable in accordance with CMMC standards (Reference PWS, Part 6, Para. 6.15).

"• The eCTD Software shall be able to be installed on-premise and in the cloud in accordance with CMMC standards."

No change.

HT942726RE005 Q&A