ValGenesis VLMS manages all types of validation processes – including electronic logbook management, GxP assets, inventory management, and application lifecycle management – through a single instance across multiple sites.
Regulated pharmaceutical and biotechnology companies are often challenged with developing their manufacturing capabilities quickly and in a cost-effective way, while at the same time safeguarding both product quality and patient safety. Validation has been an essential part of regulated industries for over forty years, and yet, as this field continues to evolve and despite regulators’ continued guidance issuance efforts, little has changed in practical, historical approaches to validation. Over time, historical validation activities have centered more and more on ever-increasing paper records and documentation, leading to persistent compliance issues. Paper-based validation requires a high degree of manual effort for document creation, routing and review, as well as approval, execution, tracking, reporting, and providing data analysis and evaluation.