Validation Best Practices Service
Some MasterControl customers prefer to execute our protocols and validate products independently. If this is your preference, MasterControl's Validation Best Practices consulting team will assist you with the organization of your Validation project, filling in the gaps to ensure a smooth execution and successful implementation.
Custom consulting services can include:
- Validation Project Planning
- Procedure Development/Consultation
- Protocol Development Training/Consultation
- Systems Audits for Regulatory Compliance
- Third-party review of Customer Documentation/Project Materials
Validation Services and Training
If you're new to validation, MasterControl's Validation Training Course may be just what you need to get up to speed. This course guides you through the FDA and GAMP regulations and methodologies for validating automated systems, applications, or processes. The two-day course familiarizes you with the proper methods for planning and executing a computer systems validation project and provides examples and exercises on the usage of the MasterControl validation toolkit and validation test protocols. Discussions during the course include information on common mistakes that can be made during execution that could cause overall project delays.
Protocol Execution Services
If you don't want to go it alone, a consultant from the MasterControl Validation Services group can guide your test team through every feature and function of the MasterControl Quality Suite application. The protocols are based on industry standards and provide full traceability back to the feature definitions of the product's Functional Requirements Specifications. They contain all of the necessary guidelines for both full validation and re-qualification testing for systems upgrades.
- IQ Execution The Installation Qualification execution services may be conducted either remotely via secure Internet connections or at your site. In both executions, our consultants will lead your personnel in the inventory and installation check of your server hardware to ensure it meets the necessary requirements for systems operation.
- OQ Execution The Operational Qualification execution services are conducted manually at your location using MasterControl's industry standard-based protocols to test and execute the various functions and operational features of the MasterControl Quality Suite application. The VSS consultant directly assists your personnel in the completion of the protocol test activities throughout the OQ process. Upon test completion, the finished protocols, test execution notes and collected screen shots become the objective evidence of the system performing to the functional design.
- PQ Execution The Performance Qualification (PQ) execution services include a customized PQ protocol detailing your baseline systems usage. The VSS consultant assists in the execution of the protocol test instructions, providing overall guidance and leadership during the implementation to ensure proper records and testing compliance.
Validation Solutions and Custom Protocol Development
Our consultants can assist you in the complete development of customized Performance Qualification protocols. Consultants begin the development process through the collection of the onsite configuration and usage procedures/work instructions for the MasterControl Quality Suite Application. The data collected will then be 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. Testing supports multiple sites and users performing simultaneous operations, proving both system stability and overall usage integrity. This service is normally contracted as a part of the PQ Execution process, providing a full Performance Qualification solution.
GxP Documentation and Validation Services
MasterControl offers three types of GxP documentation services:
- Pre-IQ/OQ Documentation Services We develop the Validation project management documentation for you, defining the validation project activities, requirements and risks. The deliverables for this task include the Validation Plan, Risk Management Plan and User requirements specification. Upon delivery, the VSSG consultant will review the document contents with you.
- Test Reporting Documentation Services Our consultant will develop the Testing Summary reports and Final Validation report for the project. Included in this documentation delivery is a review of all of the testing and project milestone information for the creation of the IQ/OQ Test Summary Report, PQ Test Summary Report and Final Validation Project Report. The VSSG consultant will perform a basic general review of the document contents with the customer upon delivery.
- Usage SOP Documentation Services This service tasking is the development of the general usage SOPs for the project. Included in this documentation delivery is the development of the Systems Administration / Configuration SOP as well as the User Account Management SOP. In addition the VSSG consultant will perform a basic general review of the document contents with the customer on delivery.
Installation and Operational Qualification Protocols
MasterControl has developed predefined protocols covering all aspects of the Installation and Operational Qualification requirements based on industry standard formats. The IQ/OQ protocols allow the manual execution of validation efforts in just a few weeks versus the lengthy task of program engineering review and self-creation of protocols that an off-the shelf or homegrown system would require.
Validation Solutions Toolkit
MasterControl's Validation Toolkit is a detailed collection of procedural templates, validation test protocols, forms and scripts designed to help your validation project team members complete the requirements for validation projects. The toolkit consists of project-level and corporate-level templates of validation documentation items and procedures such as Validation Plan, User Requirements Specification (URS), Functional Requirements Specifications (FRS), Risk Management plans and various procedures based on industry examples.
Transfer Operational Qualification (TOQ)
MasterControl Transfer Operational Qualification™ (TOQ) was especially developed for companies looking to reduce the cost and pain of validation. Based on a company's corporate policy and risk assessment, it may choose to assimilate or "transfer" OQ documentation as part of its overall validation effort, saving both time and money.
The implementation of the TOQ product is completed in two (2) separate service delivery parts:
- TOQ Implementation Review This service consists of the overall review of the TOQ Product Records from the CD ROM. A MasterControl consultant will review the complete TOQ record with you while training you to use the record in a regulated audit. During the review, the consultant will also assist you in identifying the high risk sections or functions of the system. These high risk items will be collected into a Risk Management Plan, adding the identified items to the future Performance Qualification testing effort or scheduling an additional Operation Qualification execution effort.
- Installation Qualification Execution This service consists of the execution and delivery of the completed IQ protocol with the customer.
Contact MasterControl for Validation Services and Solutions
To learn more about MasterControl validation services and solutions, feel free to contact a MasterControl representative today.