ValGenesis VLMS

ValGenesis is a 21 CFR Part 11 compliant web-based closed-loop Validation Lifecycle Management System that manages the entire validation lifecycle process.

Languages supported: English

8.6/10 (Expert Score) ★★★★★
Product is rated as #15 in category Medical QMS Software
Ease of use
Support
Ease of Setup

ValGenesis, Inc. is the leading provider of paperless validation lifecycle management software solutions, designed to provide the foundation for compliance-based validation activities for Life Sciences companies. ValGenesis, Inc. provides the first Enterprise application to manage the corporate validation lifecycle process. Through an industry peer review committee, the Parenteral Drug Association (PDA) recognized the ValGenesis solution with its very prestigious New Innovative Technology award. The ValGenesis Suite is designed to be fully compliant with U.S. FDA 21 CFR Part 11 as well as European Annex 11 requirements.

ValGenesis VLMS
ValGenesis VLMS

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Customer Reviews

ValGenesis VLMS Reviews

User in Pharmaceuticals

Advanced user of ValGenesis VLMS
★★★★★
Innovative software platform to manage Validation process as paperless

What do you like best?

I have been using Valgenesis software for more than 5 years. It made our job easier and productive. We are able to save more than 60% of the time to validate any system.

What do you dislike?

Reports need to be improved to pull the data from ValGenesis, SAP, and our QMS system for an annual product review and we need support for the data lake.

Recommendations to others considering the product:

It is a proven software platform to manage any type of validation process. The support is outstanding. Plan well for implementation, try to use their validation documentation to expedite the process, Since it is a comprehensive system, if you try to develop validation documents, this will take more than 9 months to go live. For our first site, it took a longer duration due to our complex validation requirements, for our other sites, we used their protocols as templates to reduce the implementation duration.

What problems are you solving with the product? What benefits have you realized?

We have many sites globally, particularly approvers are in the US and Germany, we are able to collaborate efficiently without any issue, including the executed validation protocols are approved in real-time and change impact assessments are reviewed on the same day. Valgenesis system helped us enforce the data integrity and governance and enabled the standardization across all our sites. After implementing ValGenesis, our audit observation significantly went down to almost none. We can't think of managing our validation process without the Valgenesis platform.

Review source: G2.com

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