ValGenesis is a global organization with head quarters in Fremont, CA. Since 2004, ValGenesis, Inc. has advocating the need for an electronic system to manage the corporate validation process to enforce consistency, enhance compliance and standardize the corporate validation process. ValGenesis, Inc has launched the first version of ValGenesis software system in 2006. ValGenesis is the first enterprise software solution to manage the corporate validation process 100% electronically. PDA (Parenteral Drug Association) has selected ValGenesis as a New Innovative technology to manage the validation process 100% electronically. From 2006 to 2008, ValGenesis team has worked with over 300 companies to understand their pain points in their corporate validation process. All these clients driven requirements have been incorporated in ValGenesis system as configurable options with built-in best practices as pre-configured process to manage the corporate validation process electronically. The next generation version of ValGenesis 2.0 has been launched in 2009, since then ValGenesis 2.0 has been implemented for major global regulated life science companies.
ValGenesis’ unique technology manages the entire validation lifecycle process end to end electronically. ValGenesis is modularized, with modules for Requirements management, validation planning, dynamic traceability matrix creation, document authoring, paperless electronic execution, periodic review scheduling, content management and change control processes. ValGenesis helps to implement and enforce validation standards and procedures that are typically buried in validation master plans, SOPs and policy documents. The ValGenesis configurable, flexible, scalable, web-based solution allows for consolidation of disparate systems used in the Validation process management and connects with other ERP and quality managements systems reducing functional and operational gaps, provides a closed loop quality process.
To provide state of the art, enterprise software applications that manage and automate the validation process, enforce compliance, improve quality, and streamline operations resulting in significant time and cost savings for companies operating in regulated environment including Biotech, Pharmaceutical, and Medical Devices industries.
To become a standard for validation lifecycle management process management