Streamlining Method Validation In Pharmaceutical Product Development With Empower Chromatography Data System

A global pharmaceutical company was using numerous analytical techniques for compound quantification, purification, and characterization, including high performance liquid chromatography as part of its drug development and approval process. While proper execution of method validation can facilitate compliance and pave the way for commercialization, the current process of validating chromatographic methods is time-consuming and prone to errors.

In an effort to synchronize method validation within the R&D units and manufacturing sites, the company sought to implement an automated method validation solution that would incorporate corporate-driven, template-based standard operating procedures (SOPs) for managing validation procedures, as well as providing a secure database to store results and enhance their ability to adhere to 21 CFR Part 11 requirements.

Continue reading to find out how the Waters™ Empower™ Software Method Validation Manager (MVM) can provide a single, comprehensive solution for your validation activities.