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.

Installation Qualification (IQ)

The MasterControl software is installed using standardized installation (IQ) scripts. These execution services are conducted remotely via secure internet connections for our on-premise clients. Our installation experts will lead your personnel in the inventory and installation check of your server hardware to ensure it meets the necessary requirements for systems operation. For our hosted and cloud clients, our installation engineers will perform all of the installation steps and provide the executed protocols to you.

Vendor Functional Testing (TOQ)

MasterControl Vendor Functional Testing™ (also known as Transfer Operational Qualification or TOQ) provides completed validation and support documentation of functional tests performed at MasterControl. This documentation serves as objective evidence that basic functions of a MasterControl application perform correctly against a specification — both functional tests performed on individual components of the system and operational tests of the whole system. These automated tests provide full regression testing with every change. You can "transfer" or assimilate this documentation into your overall validation effort and documentation, saving both time and money. MasterControl Validation consultants will walk you through the documentation to guide your review and acceptance of the materials.

Vendor Usage Testing (PQ)

MasterControl can help guide you through usage testing, also known as performance qualification (PQ). MasterControl PQ services include the development of customized PQ protocols based on the recommended testing scenarios from MasterControl VxT. MasterControl consultants start the development process through the collection of configuration and usage procedures/work instructions for the MasterControl quality suite application and by reviewing the results of validation risk assessment. The collected data is then used to create a baseline protocol that covers data integrity, security integrity, and electronic approval integrity testing from processes covering record creation, approval, and secure retrieval. Typically, this service is contracted as a part of the PQ execution process, providing a full PQ solution.

Transfer Performance Qualification (TPQ)

MasterControl Transfer Performance Qualification (TPQ) simplifies the usage testing of software validation for MasterControl customers. To verify that the software will function according to the customer's user requirements and in the intended use environment, the TPQ solution has MasterControl conduct all of the usage testing for all of our modules, based on the best-practice configuration, thereby shortening traditional testing time from months down to days. FDA-regulated companies may use the usage validation and supporting documentation as part of their overall validation efforts and evidence. By producing the reports necessary to prove validation and providing testing documentation to customers, MasterControl TPQ reduces the time and cost spent on final testing.

GxP Documentation and Validation Services

MasterControl offers three types of GxP documentation services:

  • Pre-IQ/OQ Documentation Services — Development of the validation planning stage documentation, which includes defining the validation project activities, user requirements, time frame and scope. Deliverables include the validation plan and User Requirements Specification (URS).
  • Test Reporting Documentation Services — Development of the testing summary reports and final validation report for the project. This documentation includes a review of all testing and project milestone information for a PQ test summary report and a final validation project report.
  • Usage 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; document management procedures.

Validation Solutions Toolkit

MasterControl's Validation Toolkit is a collection of procedural and validation templates designed to help your validation project team complete the requirements for validation projects. The toolkit consists of project-level and corporate-level templates of validation documentation items and procedures such as the validation plan, URS, functional requirements specifications (FRS), FDA certification letters and various procedures based on industry examples.

Contact MasterControl for Validation Services and Solutions

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