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.
|Kostenlose Ressourcen herunterladen|
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.
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.
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:
MasterControl Validation Excellence (Vx) Solution
The 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.
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.
For 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.
Customized Validation Documentation
We offer complete front-to-back services for customers whose systems have higher risks, including the following documentation:
VxT Subscription Bundle
MasterControl 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.
To learn more about MasterControl validation services and solutions, please contact a MasterControl representative today.