JA_Sole Source_MasterControl_signed_Redacted.pdf

inherent in this acquisition is vital to the on-going regulatory compliance of multiple groups within NIAID and support of users at NIAID facilities.

Originally, the Institute acquired the MasterControl software as part of an award to Dovel Technologies LLC who performed the original configuration of the software:

Purchase Order No.:75N93019P01208 Contractor: Dovel Technologies LLC Period of Performance: 9/26/2019 – 6/30/2020 Amount: $1,919,877.43

This requirement is a follow-on renewal of SaaS and a continuation of NIAID’s 2021 procurement:

Purchase Order No.: 75N93022P00215

Contractor: MasterControl, Inc.

Period of Performance: 1/1/2022 – 2/28/2022 Amount: $45,357.77

Purchase Order No.:75N93021P00189 Contractor: MasterControl, Inc Period of Performance: 1/1/2021 – 12/31/2021 Amount: $157,980.00

The required MasterControl SaaS licenses are proprietary to MasterControl Incorporated and available only through MasterControl.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. MasterControl Software-as-a-Service for Electronic Quality Management System

Project description. This requirement provides commercially available MasterControl Qx Complete SaaS as detailed in Appendix A – MasterControl Products. The MasterControl licenses include full and view-only licenses which require annual renewal in order to continue use of this software and provide the highest level of customer support. There is no software or hardware to install or manage and MasterControl provides upgrades annually. The proposed acquisition will consist of quantity options for additional full and view-only licenses.

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services

Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on Other (specify): ______________________

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number. NOI-NIAID-2103141

c. Total estimated dollar value and performance/delivery period. Total estimated dollar value, inclusive of options, is Total period of performance is March 1, 2022 – February 28, 2023.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United

States Code (U.S.C.) 253(c)(__) as set forth in Federal Acquisition Regulation (FAR) 6.302-__.

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 13.106-1(b)(2) and 13.501(a).

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

MasterControl,Inc.

6350 South 3000 East Salt Lake City, UT 84121

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). The NIAID requires a solution with the flexibility to support multiple Quality groups’ eQMS. This electronic Quality Management System allows customers to manage their documents, training, corrective and preventative actions (CAPA), Audit, Risk, Supplier, Design and Specifications processes. In the current implementation at NIAID, multiple Divisions are represented among the users. MasterControl SaaS has been configured for these groups and provides consistent operations in the existing NIAID environment. MasterControl is the only known source that has the capabilities that fulfill all the following NIAID requirements:

FedRAMP-qualified cloud-based SaaS Mature SaaS solution enabling users to maintain controlled documents in a validated environment in keeping with regulatory requirements

Provide process workflows to be configured to meet the different business needs of multiple NIAID Divisions

Automate the entire lifecycle of all quality related documents such as guidelines, policies, procedures, standard operating procedures (SOPS), and work instructions. The lifecycle includes creation, review, approvals, revision, dissemination, and obsolescence.

Must have an automated revision control to ensure that the current version of a document is available by default and that prior versions can be easily accessed on demand

Must automatically create PDF renditions of all non-PDF documents

Support customized naming conventions, numbering, and formatting of quality related documents (these are likely to vary on a Division by Division basis)

Manage quality processes, such as assessments, audits, CAPAS, change control, customer complaints, deviations, inspections, reviews, and training

Promote detection, reporting, and management of processes and activities that may signify risks to clinical research programs, and document changes to manage the risk

Enable authorized users and NIAID leadership to view – in detail and at a high level – quality related activity, status, history, and resources

Must generate reports of QMS activities and issues at the Division level, to allow review by NIAID leadership, and document the oversight of NIAID leadership

Configuration for multiple groups with flexibility to allow for differences in processes

Providing the same solution in the form of MasterControl to multiple Divisions within NIAID provides many opportunities for process integration, collaboration, and labor cost savings. Product specific software and technical support is only available through MasterControl due to the proprietary nature and protection of the software source code. MasterControl Inc. is the publisher and only provider for these licenses.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies. As required by FAR Subpart 5.2, a Notice of Intent (NOI) to award a sole source contract was publicized on January 31, 2022, on SAM.gov for 15 days announcing the Government’s intent to renew NIAID’s MasterControl SaaS. The announcement indicated the reasoning for awarding a purchase order without competition. The notice closed on February 15, 2022, and no responses to the NOI were received.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. The techniques identified at FAR 13.106-3(a)(2) will be used to ensure award will be at a fair and reasonable price.

NIAID will consider comparison the independent government estimate, and proposed prices found reasonable on previous contracts as a determining factor for price reasonableness. A final determination by the Contracting Officer will be conducted prior to award of this contract.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

The Program Office conducted the initial market research by reviewing NIAID’s existing eQMS licenses and scanning the market for potential alternatives that could satisfy the Government’s requirement. Their research concluded that MasterControl SaaS is the only source that can meet NIAID’s requirements for an eQMS. Market research conducted by the Contract Specialist (CS) included a review of mandatory priorities in accordance with FAR Subpart 8.002(a)(1) Priorities for Use of Government Supply Sources and the CS determined that none of the mandatory Government sources could satisfy this requirement.

Additional market research by the CS includes reviewing previous eQMS purchases; reviewing NITAAC and GSA Advantage market research tools; and contacting knowledgeable Government and Industry professionals. The CS contacted MasterControl to inquired about possible authorized resellers for NIAID’s SaaS renewal. MasterControl confirmed they would be the sole provider of NIAID’s renewal and verified they do not offer the SaaS through an existing government-wide contract such as NITAAC, GSA, or NASA SEWP. Additionally, NIAID did not receive any inquiries to the Notice of Intent to Sole Source that was posted on SAM.gov for this requirement. In conclusion, the market research supports a sole source award to MasterControl, Inc. as the only source available to the Government for the renewal of these SaaS licenses.

9. Any other facts supporting the use of other than full and open competition.

NIAID performed a price analysis of the cost of continuing the use of MasterControl Software-as-a-Service (SaaS) versus replacing it with a compatible system, if available, that meets all of the NIAID requirements. The analysis shows that the labor cost to replace MasterControl with a comparable SaaS will cost NIAID over $2.25 million.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. No sources expressed an interest, in writing, to the synopsis that was published on SAM.gov indicating intent to issue a sole source award to MasterControl, Inc.

SSQC1FN Option A3: Qx Complete - Full Named User 50 SSQC1BN Option B1: Qx Complete - Basic Named User 50 SSQC1BN Option B2: Qx Complete - Basic Named User 50 SSQC1BN Option B3: Qx Complete - Basic Named User 50 SSQC1BN Option B4: Qx Complete - Basic Named User 50 SSQC1BN Option B5: Qx Complete - Basic Named User 50 SSQC1BN Option B6: Qx Complete - Basic Named User 50 SSQC1BN Option B7: Qx Complete - Basic Named User 50 SSQC1BN Option B8: Qx Complete - Basic Named User 50