San Francisco, December 7, 2020:

ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management Systems (VLMS), announced that a global medical devices company has digitized its corporate validation process, driven by cloud-based ValGenesis VLMS – the industry’s most trusted electronic validation lifecycle management system. The company is a global leader in continuous glucose monitoring (CGM) systems.

Recognizing that traditional, manual, paper-based validation and regression testing processes had proven costly and inefficient, the company had made the decision to go paperless with ValGenesis VLMS. ValGenesis has met this client’s validation lifecycle needs through significant automation and by providing value in key areas including system assessment, risk assessment, regression testing, review and approval cycles, test execution, real-time evidence capturing, dynamic trace matrix generation, change management, and periodic review programs. The company had commenced with computer system validation and then expanded to equipment validation, with plans to further expand into design and process validations. ValGenesis VLMS enables remote validation execution, preventing interruptions in the company’s validation programs especially in these times when their workforce is predominantly remote and/or working from home. The system is configurable and scalable to facilitate implementation at a single site and expansion across multiple sites in the future.

“We are excited to partner with this client in its ongoing digital transformation journey. ValGenesis VLMS is the ideal solution for companies interested in reducing overall validation cycle time while realizing significant gains. This frees them up to focus on what they do best while we work behind the scenes to deploy a homogenous solution that helps them embrace organization-wide transformation in the spirit of Pharma 4.0,” says Narayan Raj, Sr. Vice President of Global Sales & Operations at ValGenesis, Inc.

About ValGenesis

ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.

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Further information:

Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex.1026,

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