Waters Expands Open Architecture Operating Platform with new Automated and Integrated Method SOP Software

Waters Corporation today expanded its informatics open architecture operating platform, anchored by the Waters NuGenesis Scientific Data Management System (SDMS), to address predominately manual activities required to perform standard operating procedures (SOPs) for analytical methods or tests.

The Waters^® NuGenesis^® SDMS Intelligent Procedure Manager is a workflow software package designed to guide a laboratory analysts through routine, comprehensive method SOPs and integrate results with a chromatography data system, such as Waters Empower™ 2 Chromatography Data Software.

“Waters’ laboratory informatics solutions inherently promote an open architecture that invites collaboration among instruments, vendors and departments,” said Phil Kilby, Senior Manager, Informatics Marketing for Waters Division. “As the only laboratory software package able to manage and interrogate scientific data from any source, NuGenesis SDMS is the nerve center of this open informatics platform. Leveraging the well-founded benefits of open architecture, Waters’ platform is designed to allow laboratories to bring instruments and software online compartmentally until full enterprise-level integration is realized.”

The Intelligent Procedure Manager is the latest such solution being introduced at Pittcon 2008. “Supporting a ‘Right the First Time’ philosophy, Waters estimates that using the Intelligent Procedure Manager to automate and integrate method SOPs could potentially reduce cycle times by as much as 50 percent compared to a traditional paper trail, with fewer opportunities for errors,” continued Kilby.

The Intelligent Procedure Manager meets the need of today’s manual or paper-driven SOP guidelines that still dominate certain laboratory functions. For example, 1) instrument checks, 2) standards and sample preparation, 3) solvent and mobile phase separation, 4) analyses review, 5) result approval, and 6) final product release are all prone to time inefficiency and data transcription errors because they depend on paper guidelines.

From late stage development to final product quality control and lot release, Intelligent Procedure Manager can be equally applied to any lab environment where rigorous adherence to approved test methods and SOPs must be followed, including compliance requirements for cGMP operations. All primary laboratory data and metadata are quickly and easily acquired in electronic form and stored in a secure, 21 CFR Part 11, cGMP-, GLP- compliant database.