Demo: MasterControl Validation Excellence Tool

This video introduces the MasterControl Validation Excellence Tool (VxT), a patented methodology designed to transform the traditionally burdensome process of software validation within life sciences companies. The core objective of VxT is to shift validation from a time-consuming "necessary evil" into a strategic competitive advantage by drastically reducing the time required—moving the process from a "marathon" to a "sprint." Developed with the oversight of former FDA officials, VxT focuses on creating a reliable, risk-based assessment that is tailored to the specific configuration and intended use of the MasterControl software by the client organization.

The VxT methodology centers on a guided wizard approach to create a customized validation plan. This process begins with a thorough review of business risks, leading to the development of a project-level risk mitigation plan based on the client's unique system configuration and operational intent. For the initial validation of the MasterControl platform, VxT helps determine and document high-risk items. These documented risks are then used to write and execute custom usage testing protocols that align precisely with the company's specific business practices and intended system use, ensuring that the validation is meaningful and robust enough to repeatedly pass regulatory inspections without incident.

The most significant advantage of VxT is realized during the software upgrade process. Traditional validation often requires re-validating the entire system after an upgrade, consuming weeks or months of effort. VxT employs a sophisticated change control mechanism that only assesses features that have actually changed and only on the specific modules the client is actively using. This targeted approach dramatically cuts the validation timeline, potentially reducing a multi-week process down to a few days, hours, or even minutes. By accelerating validation, VxT enables companies to quickly adopt the latest MasterControl features, ensuring continuous quality assurance throughout the product lifecycle, from concept through commercialization, thereby speeding up time-to-market for life-changing products.

Key Takeaways:

• Risk-Based Validation Methodology: VxT utilizes a patented, risk-based approach to software validation, moving away from comprehensive, time-intensive testing of all features toward focusing resources on high-risk areas specific to the user's configuration and business processes.
• Regulatory Assurance: The tool was developed with the oversight of former FDA officials, providing confidence that the methodology meets or exceeds regulatory expectations and has a proven track record of passing regulatory inspections without compliance incidents.
• Customized Validation Planning: The system uses a guided wizard to help users create a validation plan that is entirely customized. This plan is derived from a review of specific business risks and the intended use of the configured MasterControl system.
• Efficiency in Initial Deployment: During the first validation, VxT identifies and documents high-risk items, which are then used to generate and execute custom usage testing protocols that reflect the company's unique operational environment, ensuring focused and effective testing.
• Dramatic Reduction in Upgrade Validation Time: The primary value proposition lies in the change control process for software upgrades. By only assessing features that have changed and limiting the scope to active modules, VxT reduces re-validation time from weeks or months to potentially minutes.
• Strategic Competitive Advantage: Accelerated validation allows life science companies to adopt new features and technologies faster, ensuring they maintain the latest operational efficiencies and quality controls, which translates directly into getting products to market sooner.
• Focus on Intended Use: The methodology emphasizes validating the software based on the company's intended use and custom configuration, ensuring that testing is relevant to real-world business practices rather than generic system functionality.
• Digital Transformation of Compliance: VxT helps digitize and automate the compliance process, transforming validation from a manual, paper-heavy burden into an integrated, streamlined, and repeatable digital process.

Tools/Resources Mentioned:

• MasterControl Validation Excellence Tool (VxT)
• MasterControl Change Control (used within VxT for upgrades)

Key Concepts:

• Validation Excellence Tool (VxT): A patented methodology and software tool designed to streamline and accelerate the software validation process in regulated life science environments by implementing a risk-based, configuration-specific approach.
• Project-Level Risk Mitigation Plan: A strategy developed using the VxT wizard that identifies and plans for mitigating risks specific to a company's configuration and intended use of the MasterControl software, ensuring compliance and operational integrity.
• Custom Usage Testing: Testing protocols generated based on the documented high-risk items and the specific business practices of the client, ensuring that validation efforts are highly targeted and relevant to the company's actual operations.