JA_SSJ_Master_Control_Redacted.pdf

NCQMS MasterControl software is responsible for managing controlled documents and quality processes related to NIAID’s role as a Sponsor of clinical trials. The continuity of service 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 through full and open competition 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

Subsequent renewals of the SaaS have been restricted acquisitions through the open market.

Purchase Order No.: 75N93023P00584

Contractor: MasterControl Solutions, Inc. (Formerly MasterControl, Inc.)

Period of Performance: 7/7/2023 – 6/30/2024 Amount: $481,165.52

Purchase Order No.: 75N93022P00407

Contractor: MasterControl, Inc.

Period of Performance: 3/1/2022 – 4/30/2023 Amount: $495,283.42

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 Solutions, 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): Renewal of services (Purchase Order

75N93023P00584)

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-24-2216266

c. Total estimated dollar value and performance/delivery period. Total estimated dollar value, inclusive of options, is (Base

, Options ). Total period of performance is July 1, 2024 – June 30, 2025.

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

This acquisition is conducted under the authority of FAR subpart

13.5 in accordance with 41 United States Code (U.S.C.) 1901.

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 Solutions, Inc.

6350 South 3000 East Salt Lake City, UT 84121

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. NIAID, in its role as Sponsor of Clinical Trials, has developed internal procedures based on the MasterControl solution. These internal procedures would need to be updated and changed if the Institute were to adopt another system, causing delays in the management of digital clinical trial documents, and potentially risk falling out of regulatory compliance. In addition, staff would need to be re-trained on the new system, which would also cause delays and create regulatory risk.

Awarding this acquisition to another vendor and implementing a different eQMS is not a reasonable solution as it would cause significant cost increases for NIAID stemming from the need to migrate data and retrain staff. NIAID performed a price analysis of the cost of continuing the use of MasterControl SaaS versus replacing it with a compatible system, if available, that meets all of the NIAID requirements. The analysis shows labor costs in excess of $2.25 million would be required to replace MasterControl exclusive of the cost of the new solution. Based on this information, the Government would take an unacceptable risk if award were made to a vendor other than MasterControl.

The following additional eQMS capabilities are required by NIAID and are not reasonably available from other vendors without significant investment from NIAID:

Mature FISMA/FedRAMP certified SaaS solution enabling users to maintain controlled documents in a validated environment in keeping with regulatory requirements

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

Automate the entire NIAID-specific 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.

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

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 Solutions, 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 presolicitation Notice of Intent (NOI) to award a sole source contract was publicized on May 28, 2024, on SAM.gov for 15 days announcing the Government’s intent to renew NIAID’s MasterControl SaaS. The notice closed on June 12, 2024, and one response was 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 comparing 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. The required software is proprietary to MasterControl. All product source code, database structures, technical documentation, installation instructions, sub-components, requirements specifications, design artifacts, user manuals, etc.… are the intellectual property of MasterControl which reserves all rights. A search was conducted using NITAAC CIO-CS, GSA Advantage, and NASA SEWP market research tools. The NITAAC and GSA Advantage searches did not produce any results for MasterControl. The NASA SEWP search revealed a MasterControl reseller, Four Points Technology, for a productivity software solution, not the required eQMS. MasterControl confirmed they would be the sole provider of NIAID’s eQMS renewal and verified they do not offer the SaaS through an existing government-wide such as NITAAC, GSA, or SEWP. 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.

None.

HHS Senior Procurement

Executive

N/A

APPENDIX A – MASTERCONTROL PRODUCTS

Mfg. Part No. Description Qty SVALSRV200 Annual Validation Subscription 1 SSQC1FN Qx Complete - Full Named User 500 SSQC1BN Qx Complete - Basic Named User 465 SSPL5PK PLx Starter - 5 Full Named User / 5 Basic Named User 1 SSQC1FN Option A1: Qx Complete - Full Named User 10 SSQC1FN Option A2: Qx Complete - Full Named User 10 SSQC1FN Option A3: Qx Complete - Full Named User 10 SSQC1FN Option A4: Qx Complete - Full Named User 10 SSQC1BN Option B1: Qx Complete - Basic Named User 35 SSQC1BN Option B2: Qx Complete - Basic Named User 35 SSQC1BN Option B3: Qx Complete - Basic Named User 35 SSQC1BN Option B4: Qx Complete - Basic Named User 35