Global life science firm chooses Paperless change management and validation system to expedite discovery and global delivery of critical Neurology and Oncology drugs.
SAN FRANCISCO, March 6, 2019 /PRNewswire/
ValGenesis, Inc., a leading provider of Validation Lifecycle Management System (VLMS) software solutions, today announced that a leading R&D-based pharmaceutical company has chosen to implement ValGenesis’ s 100% paperless VLMS to manage its corporate validation lifecycle process.
The company operates globally in terms of R&D, manufacturing, distribution and marketing, with a strong focus on prescription medicines, especially in the therapeutic areas of neurology and oncology. It has developed and provided products and services for over seventy-five years to patients under any healthcare system, through a network of more than forty worldwide subsidiaries, including ten production sites and fifteen drug discovery, R&D and clinical research sites.
After an extensive period of investigation and study, the company decided that the ValGenesis Enterprise VLMS—an electronic, paperless, cloud-based SaaS solution—should replace their existing solution to manage the change process for computer system validation, as well as to meet all other lifecycle validation needs. The customer will implement the ValGenesis VLMS solution to commence with risk-based validation and change control and, in the near future, will extend to 100% paperless process for Computer systems, Equipment, Cleaning and Process validations. With ValGenesis Enterprise VLMS, the company will significantly reduce validation cycle time, gain a higher standard of data integrity, improve regulatory compliance, and effortlessly manage change. They will also gain a holistic view of real-time validation status across regulated systems, thereby improving the quality and speed of the entire process. The company plans to roll out the ValGenesis solution globally, upon successful completion of this initial implementation.
“ValGenesis has proven itself as system of record for validation processes to all types of life science companies and is delighted to sign up with a pharma giant focused on the therapeutic areas of neurology and oncology,” said Narayan Raj, Sr. Vice President of ValGenesis Inc. “The configurable nature of ValGenesis VLMS helps global companies implement at a single site or process and its scalability makes it easy to expand globally. We look forward to our role as a strategic partner and providing a robust framework to meet this firm’s validation lifecycle management needs.”
Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026,
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 https://www.valgenesis.com