Eliminate Waste. Improve Quality & Efficiency

For over 40 years, validation processes have remained fairly constant, paper-based and manually-driven.  The rapid pace of changing technology and innovation has driven companies to demand that you do more with less.  Cloud technologies, the Internet of Things, cybersecurity, mobility and other innovations are changing the way we work and live.  Quality is still an imperative and is now more important than ever.  Given all of the change, it is time to re-think current validation strategies.  

Lean manufacturing is a systematic process designed to eliminate or minimize waste ("Muda") throughout the manufacturing process without sacrificing productivity. Lean manufacturing also considers waste created through overburden ("Muri") and waste created through unevenness in work loads ("Mura").  Lean Validation applies these same principles the validation process to help minimize/eliminate waste without sacraficing quality and efficiency.

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Each Tuesday, we will be hosting a LIVE webinar discussing lean validation principles and best practices and showing you in a live demonstration how ValidationMaster™ powers lean validation.  Click the REGISTER NOW link to select the date most convenient to you.

Automating Validation Processes

Validation as we know it is DEAD.  Manual, paper-based processes hinder productivity and efficiency throughout the validation process.  The pillars of lean validation are the elimination of wasteful validation processes, minimizing risk, optimizing the validation process, driving efficiency and quality and ensuring sustained compliance.    None of these pillars can be achieved without automation.

Lean validation requires automation to eliminate wasteful processes.  Establishing, tracking and managing user requirements on paper is an arduous process.  To track requirements on a granular level is difficult on paper.  Automation can help drive greater efficiency and compliance.  Creating and executing test scripts is one of the most time-consuming validation tasks yet many companies still conduct validation testing on paper.  It is clear that the more an application is tested the greater the chance of revealing an error.  However, it is not practical using manual means to conduct testing sufficient for complex applications without expending significant effort to do so.  Automation is essential to drive this process.

 

Lean Validation Benefits

  • STREAMLINED AUTOMATED PROCESSES - Lean validation is powered through automation.  Our solution, ValidationMaster, is designed to drive lean validation processes, improve quality and ensure sustained compliance.   The elimination of manual, paper-based processes allows you to focus on more rigorous testing to identify more errors and improve software quality.
  • ELECTRONIC PROCESS WORKFLOWS - One of the key bottlenecks in any validation process is the document approval process.  Manual routing is inefficient and time-consuming.  ValidationMaster™ supports fully electronic workflows that offer electronic routing, review and approval through DocuSign®.  On any mobile or desktop computer, you can easily sign with legally defensible electronic signatures.  If you prefer user name/ID combination electronic signatures with 21 CFR Part 11-compliant audit trails, ValidationMaster™ has this option as well.
  • SINGLE SOURCE OF TRUTH FOR VALIDATION - Managing validation documentation in a controlled manner for all validation projects takes discipline.  Lean validation powered by ValidationMaster™ supports the ability to establish an inventory of all validation projects (equipment validation, computer systems validation, process validation, et al).  You have ONE PLACE to go for all of your validation projects.  You can track periodic reviews, validation status, and much more.
  • IMPROVED COMPLIANCE & QUALITY - Lean validation is all about delivering greater quality and compliance.  Through automation, the system tracks and manages each requirement, incident, test script, and all validation deliverables in accordance with global regulatory guidelines.  Quality best practices are built in to ensure consistency across each integrated process.
  • FULLY AUTOMATED VALIDATION TEST SCRIPT DEVELOPMENT & EXECUTION - Test script automation is at the core of ValidationMaster™.  The system offers the ability to generate FULLY AUTOMATED java-based test scripts or electronic (paperless) test scripts which may be executed online through ValidationMaster™.
  • INTEGRATED TECHNOLGY DESIGNED EXCLUSIVELY FOR VALIDATION ENGINEERS - ValidationMaster™ is designed to work the way validation engineers work.  The system integrates enterprise requirements management, content management, incident management, automated testing, source code management and other features to support lean validation processes.  We integrate out of the box with popular 3rd party tools you may already be using to support validation efforts including Selenium, Neoload, Ranorex, Jira, BugZilla, IBM Doors, Jama Contour, VersionOne, HP Quality Center, Sparx Enterprise Architect, Microsoft Team Foundation Server (TFS), NUnit (unit testing), and many more.  Contact us for more information.
  • INTERNATIONALIZATION - Today's lean companies work across the globe.  Your validation system should also be global to allow you to provide evidence of your validation due diligence to global regulators.  ValidationMaster™ supports over 160+ global languages including Spanish, German, Japanese, Dutch, French, Chinese and many more.

 

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