Validation Services and Solutions

MasterControl provides industry best practice-based validation services and products to meet all of your compliance, validation and process change management needs. Our highly skilled experts come from a variety of industry backgrounds and have decades of collective industry experience. They will help you meet today's regulatory requirements and complete your system's process compliance.

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Download Free Resources
Product Data Sheet: MasterControl Validation Strategy and Advantages
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Product Data Sheet: MasterControl Transfer OQ™
Product Data Sheet: MasterControl Transfer Performance Qualification (TPQ)
White Paper: 21 CFR Part 11 System Validation (Risk Management Plan)
White Paper: Pragmatic Approach to Computer Systems Validation
White Paper: Change Control - Continuous Quality Improvement in FDA and ISO Environments
White Paper: Automating Document Control Processes
White Paper: MasterControl: What's the Return on Investment?
Case Study: Validation a Focal Point in LifeCenter Northwest’s Implementation

Installation Qualification (IQ)

The MasterControl software is installed using standardized installation (IQ) scripts. These execution services are conducted remotely via secure internet connections. 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.

Transfer Operational Qualification (TOQ)

MasterControl Transfer Operational Qualification™ (TOQ) provides completed validation and support documentation of IQ/OQ 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. You can "transfer" or assimilate this documentation into your overall validation effort and documentation, saving both time and money.

Performance Qualification (PQ)

MasterControl can help guide you through PQ testing. MasterControl PQ services include the development of customized PQ protocols. MasterControl consultants start the development process through the collection of configuration and usage procedures/work instructions for the MasterControl quality suite application. 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 PQ portion of software validation for customers of Spark, MasterControl's hosted QMS for companies with fewer than 50 employees. 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 PQ testing for Spark customers, thereby shortening traditional testing time from months down to days. FDA-regulated companies may use the PQ 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.

Validation Best Practices Services

MasterControl can assist you with the organization of your validation project, filling in any gaps to ensure a smooth execution and successful implementation.

Custom consulting services can include:

  • Validation Project Planning
  • Procedure Development/Consultation
  • Protocol Development Training/Consultation
  • Third-party Review of Customer Documentation/Project Materials

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, 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.