Robust, end-to-end solution that manages the Validation Lifecyle Process
Validation programs are still almost entirely manual or consist of a number of separate, uncoordinated systems. Inefficiencies caused by human error cost manufacturers millions of dollars annually, increase product time to market, and introduce quality problems and data integrity issues. As the industry moves to PHARMA 4.0, companies are looking for a total validation management solution that ensures best practices and data integrity governance, enforcing them across all validation processes.
The ValGenesis VLMS is a 100% paperless Validation Lifecycle Management System that has been adopted as a system of record for validation since 2006. An end-to-end modularized system, the ValGenesis VLMS manages all types of validation processes, including CSV, Equipment, CQV, Method, Cleaning, and Process. It is packed with unique features yet unmatched in the industry. Over 50 top global life sciences companies testify to its efficacy after being audited and approved by global regulatory bodies as a system
Unique Features and Advantages of ValGenesis VLMS
Enforce approved Validation Plans, procedures and best practices – A decision tree driven validation assessment process helps define the validation requirements for GxP systems and processes as per the approved validation plan and procedures. Real-time validation status of these GxP systems and processes are available in the dashboard
Efficient process to generate validation deliverables – ValGenesis VLMS provides functions to reuse content across the organization. It supports parallel, serial and hybrid workflows for review and approval to expedite the final approval process
Comply with ALCOA and Part 11/Annex 11 requirements – Upon clicking the record button during validation execution, data and content populate contemporaneously across rows with exact date and time stamps, along with screenshots/attachments
Offline execution support through Mobile Apps – Test case execution is supported via tablets/ mobile, with or without network connectivity, objective evidence are dynamically captured in accord with the spirit of FDA 21 CFR Part 11 and EMA Annex 11
Dynamically generate many types of trace matrices with minimal effort – Create references for requirements and test cases with a simple click. Dynamically generate any type of trace matrix: comprehensive end-to-end, V model, one-to-many, and many-to-one traces of all artifacts. The VLMS supports forward and backward traces
Efficient Risk based validation – Conducting risk assessment at the system and requirement level becomes easy to implement. The entire process is guided by the system. Any type of risk model can be adopted to conduct the risk assessment Requirement Level impact assessment - Reduce change management effort by up to 80% as a validation summary of all impacted artifacts is dynamically generated
Access and archive dynamic data through IoT and OPC – IoT enabled access/capture of temperature, pressure, and humidity data in clean rooms, freezers, etc. The VLMS further supports shipping and cold chain validation. Data can be collected from instruments (pH meter, weigh balance, etc.) and directly populated in validation protocols, batch records, and log forms
Robotic validation execution support – The VLMS leverages the power of test automation tools for robotic validation execution and reduces validation execution time by up to 90%. Validated connectors for commonly available automation testing tools including UFT, MS Coded UI, Leapwork, Tosca, etc. are provided
Multilingual support – At site and user level. Any language can be supported. German, French, Japanese, Portuguese, Spanish, and Chinese are currently supported by default
The ValGenesis VLMS is designed to electronically manage the entire validation lifecycle and remove the inefficiencies that plague paper-based processes. ValGenesis reduces the cost of the validation process by allowing the optimization and stabilization of existing processes along with electronic management (document authoring, test execution, review and approval) of validation process and procedures. This reduces the cost of the validation process as much of the paper-based documentation and process/procedure approvals are eliminated.
ValGenesis VLMS is expected to reduce the cost and time of the validation lifecycle process by at least 50% if it is specifically configured to meet your validation process