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ValGenesis to digitize enterprise-level validation processes for leading T-cell immunotherapy company

ValGenesis News | Published: March 2, 2020

San Francisco, March 2, 2020

ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management solutions today announced that a leading biopharmaceutical company in the U.S., has chosen ValGenesis’s cloud-based, 100% paperless Validation Lifecycle Management System (VLMS), to digitalize computer system validation processes across their organization.

The company is a leader in T-cell immunotherapy and develops novel treatments for patients with cancer, autoimmune and viral diseases through its technology platform that leverages research and collaborations with leading academic institutions, and its scientific, clinical, regulatory and manufacturing expertise.

The company is implementing ValGenesis VLMS with a goal to gain an enterprise-level, real-time view of validation status across their regulated systems. ValGenesis will digitize their computer system validation processes and subsequently digitize commissioning and qualification processes for their new manufacturing site.

Comprehensive and easily configurable, the VLMS is a cloud-based, SaaS, end-to-end validation lifecycle management system with powerful collaborative, risk-based, and change management functionalities that enable swift and audit-ready processes at enterprise level. The VLMS has been implemented in 5 continents by global life science and biopharmaceutical companies as a system of record for validation.

“We are very excited to work with this leader who is developing cutting-edge T-cell immunotherapies that raise the hope of a cure for people with malignancies across the globe. We are humbled to play a role in streamlining their processes as they enter an exciting new era in cancer treatment,” says Narayan Raj, Sr. Vice President of Global Sales & Operations at ValGenesis, Inc. “The VLMS will help them automate and optimize all validation processes, with enhanced visibility and traceability. We look forward to their broadening use of our system across their enterprise as a global validation system.”

 

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.

For more information, visit www.valgenesis.com

Further information:

Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex.1026 althea.dsylva@valgenesis.com

Summary

Comprehensive and easily configurable, the VLMS is a cloud-based, SaaS, end-to-end validation lifecycle management system with powerful collaborative, risk-based, and change management functionalities that enable swift and audit-ready processes at enterprise level.

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