For many life sciences companies, validation is the most excruciating part of compliance. But our proven methodology drastically reduces validation time and effort. We offer a full array of validation solutions and services based on regulatory guidances to help you maintain a continuous state of compliance.
Our time-tested and process-centered methodology accelerates validation processes without sacrificing the thorough risk evaluations and testing you need in order to meet compliance requirements.
Our patented Validation Excellence Tool (VxT) cuts validation time from months to days, if not hours. It assesses risks, offers testing recommendations and helps you focus on critical processes.
Our specialized validation services are based on best practices that have been expertly refined during the 25-plus years we’ve been validating software systems.
The MasterControl Platform is the foundation for complete product quality – connecting applications, documentation and data across your entire product development life cycle, from concept to commercialization.
The MasterControl Validation Toolkit furnishes all the project and corporate-level templates of validation documentation items and procedures that teams need to fulfill all relevant validation project requirements. It serves as the starting point for validating your MasterControl system and any other software that supports your regulated products and services.
In accordance with the least burdensome approach to validation espoused by leading regulatory agencies like the FDA, our Validation Excellence Solution combines the Automated Transfer Operation Qualification (ATOQ) functional testing solution with the Transfer Performance Qualification (TPQ) usage testing solution to help ensure your system’s validation.
Our patented Validation Excellence Tool (VxT) accelerator provides a fast, efficient and seamless validation experience that other cloud providers couldn’t dream of achieving. On average, customers using VxT have reduced 104 hours of labor-intensive validation activities to 20 hours and have also cut at least 336 hours in overall project preparation time. And there is no additional cost to use it!
We offer complete front-to-back validation services that provide documentation such as TxQ risk assessments, Validation Excellence Tool (VxT) initial risk assessment/change control risk assessments, risk-based usage testing and validation reports.
Our expert consultants are available to guide your entire validation effort, from the risk assessments derived from VxT — including usage testing creation and execution, if recommended by VxT — to a usage testing summary report and a final validation report. A subscription bundle is available on an annual or quarterly basis and includes the initial activities necessary to achieve a validated state utilizing VxT and then leverages the VxT change control process to maintain your validated state.
We offer additional validation services to address integration utilities, custom forms and data verification qualification, as well as blocks of time that can be used for validation consultation or guidance.
Learn how our cutting-edge tools and start-to-finish validation solutions and services can help you reduce the time, effort and costs involved in validating your systems.
