Validation Services and Solutions

Most regulated companies struggle with the high cost and heavy burden of software validation. Our groundbreaking methodology, MasterControl Validation Excellence (Vx), is designed to significantly reduce the time and effort involved in the validation process. We offer full, start-to-finish validation solutions and services to help regulated companies like yours maintain a state of constant compliance.

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MasterControl Validation Excellence (Vx)

Unlike other software providers, we don’t believe in handing you ready-made validation documentation as a short cut. We want you to fully understand your software risks and focus on your critical business processes (CBPs). We developed Vx to accelerate the validation process without sacrificing a thorough risk evaluation and testing. It will put you in the driver’s seat by combining a best-practice software lifecycle approach with the use of an innovative, risk-evaluation tool.

MasterControl Validation Excellence Tool (VxT)

The VxT is the centerpiece of our methodology. The cutting-edge, cloud-based application is designed to cut your overall validation time from months to days, if not hours. It will provide you with an assessment of your software risk, help you leverage MasterControl’s validation protocols, help you focus on your CBPs, and make a recommendation with regard usage testing.

Validation Solutions

Validation Toolkit: The toolkit provides a starting point for validating your quality management system and other software supporting regulated products and services, such as manufacturing, laboratory, and clinical trial systems.

The toolkit includes:

  • Validation Plan
  • Functional Requirements Specifications (FRS)
    • Functional Testing (Automated Transfer Operational Qualifications or ATOQ)
    • Traceability Matrix
  • User Requirements Specifications (URS)
    • Traceability Matrix
  • Usage Testing (Transfer Performance Qualifications or TPQ)
  • IQ Protocols
  • Final Validation Report

MasterControl Validation Excellence (Vx) SolutionThe Vx Solution combines a functional testing solution, also known as Automated Transfer Operational Qualification (ATOQ), and a usage testing solution or Transfer Performance Qualification (TPQ). In accordance with the FDA’s least burdensome approach, you may incorporate this documentation into your overall validation project.

  • Functional Testing (ATOQ): The solution provides completed validation and support documentation of MasterControl’s internal IQ/OQ tests. The documentation serves as evidence that basic functions of MasterControl application performs correctly against a specification. It includes functional tests performed on individual components of the system and operational test of the whole system. We perform full ATOQ validation for each module for each version of our software.
  • Usage Testing (TPQ):Our extensive manual usage testing verifies that the software will function according to our best-practice configuration requirements. These protocols go through a full validation process, quality review, and approval prior to release for client use. The TPQ protocols are updated each release based on new system enhancements and any changes to MasterControl best practices.

MasterControl Validation Excellence Tool (VxT): The application consists of two parts: Initial Risk Assessment and Change Control Assessment. When you buy any MasterControl solution, you will be able to take full advantage of the tool.

PQ LibraryFor companies whose customized processes might not be fully covered by the Vx Solution, we provide full PQ templates for each MasterControl module for every annual release. The templates make it easier for clients to write and execute their own usage testing based on their unique configurations.

Validation Services

Customized Validation DocumentationWe offer complete front-to-back services for customers whose systems have higher risks, including the following documentation:

  • Installation Qualification (IQ) Documentation Services: Development of validation planning stage documentation, defining validation project activities, requirements, time frame, and scope. Deliverables include the validation plan and URS.
  • TxQ Risk Assessment: The TOQ/TPQ assessment provides an in-depth review of the project-level risks of implementing MasterControl, including business, system, and validation risks. It entails a review of the internal strategy documents with clients to ensure they can properly leverage the testing as part of the client-specific validation. We also perform the VxT Software Usage Risk Assessment to determine which CBPs should undergo additional client-specific testing, if at all.
  • Validation Excellence Tool (VxT): Using VxT, clients will review their specific configuration and usage risks to determine the scope of the customized risk-based usage testing.
  • Customized Risk-Based Usage Testing: Based on the CBPs identified through VxT, MasterControl consultants will write customized usage testing protocols for high-risk areas of your intended usage.
  • Test Reporting Documentation Services: Development of testing summary reports, including a review of all testing and project milestone information for PQ test summary report and a final validation report.
  • Usage Standard Operating Procedure (SOP) Documentation Services: Development of all SOPs to support the implementation, validation, and maintenance of your system. This can include work instructions for system usage, system administration and configuration procedures, training procedures, and document management procedures.

VxT Subscription BundleMasterControl consultants will guide a customer’s validation effort from risk assessments using the VxT through the TOQ and TPQ process, including PQ creation and execution if needed. The bundle includes a second validation package for a system upgrade the following calendar year, leveraging the VxT Change Control process. With this service, customers will be able to upgrade more often and enjoy the latest security features and enhancements at a much lower cost than hourly services.

Contact MasterControl for Validation Services and Solutions

To learn more about MasterControl validation services and solutions, please contact a MasterControl representative today.