Paperless validation to expedite manufacture & delivery of dosage forms and therapeutic categories.
SAN FRANCISCO, Feb. 12, 2019 /PRNewswire/
ValGenesis, Inc. today announced that one of the world’s largest, top rated life science companies has chosen to implement ValGenesis’s 100% paperless Validation Lifecycle Management System (VLMS) across all its global sites to manage the corporate validation lifecycle process.
For over a century, the company has developed differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. It is the world leader in invitro and tissue-based cancer diagnostics, as well as a frontrunner in diabetes management. The company has been recognized as the group leader in sustainability within pharmaceuticals, biotechnology and life sciences industries for many years. The combined strengths of both pharmaceuticals and diagnostics under one roof have made it a leader in personalized healthcare.
To harmonize and standardize the validation process at the enterprise level, this pharma giant decided to go paperless in their validation process for equipment, process, cleaning and method after realizing traditional, manual, paper-based validation processes were proving both costly and inefficient. This company conducted a detailed evaluation process of multiple solutions. Upon completion of their evaluation, they determined that ValGenesis VLMS—with its in-depth functionality and multilingual support—offered significant improvement to the current validation process in terms of increased efficiency, reduction in validation lifecycle times, improvements in regulatory compliance as well as a holistic view of site validation status, making ValGenesis the system of choice.
With ValGenesis Enterprise VLMS, the company will significantly reduce validation cycle time, gain a higher standard of data integrity, improve its regulatory compliance process, and gain a holistic view of real-time validation status across its regulated systems, thereby improving the quality and speed of the entire process.
Commented Narayan Raj, Vice President of ValGenesis, “This large pharma giant is proactively addressing a growing need by automating critical areas including validation processes. ValGenesis is known for helping global companies such as this, electronically manage their validation processes, reduce validation cycle times, as well as enforce consistency and compliance in the corporate validation process. The scalability and configurable nature of ValGenesis VLMS helps global companies such as this to implement a solution that meets their global needs. ValGenesis allows corporate quality leaders to have real-time visibility into the validation status of GxP assets, systems or processes and enables the reuse of validation data and protocols, thus ensuring a reduction in validation cost and cycle time with improved consistency. We look forward to becoming a strategic partner and providing a robust framework to meet this iconic company’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 the 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. As the first fully paperless solution for managing validation execution and approval 100% electronically, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005. The solution is also fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements.
For more information, visit https://www.valgenesis.com