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Paperless validation system aims to harmonize and standardize the validation process across all its global sites
February 12, 2019
By: Kristin Brooks
Managing Editor, Contract Pharma
A top 10 global pharmaceutical company has chosen to implement ValGenesis, Inc.’s paperless Validation Lifecycle Management System (VLMS) across all its global sites to manage the corporate validation lifecycle process. The undisclosed pharma company develops differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. The company also provides in vitro and tissue-based cancer diagnostics, as well as diabetes management. To harmonize and standardize the validation process at the enterprise level, the company has decided to go paperless in its validation process for equipment, process, cleaning and method after realizing traditional, manual, paper-based validation processes were proving both costly and inefficient. This company determined that ValGenesis VLMS 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. With ValGenesis Enterprise VLMS, the company aims to 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. 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. 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.”
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