CSols and Waters have launched a joint effort to improve laboratory scientific data management and make 21CFR Part 11 compliance much easier.

As part of the agreement, CSols has ensured that its award-winning Links for LIMS software now works with Waters’ market-leading Millennium32 chromatography software and also with any other laboratory information management (LIMS).  Links for LIMS is invoked directly from within Millennium32 software and manages two-way communication between Millennium32 and LIMS or enterprise resource planning (ERP) systems.

Waters Millennium32, an enterprise scalable client/server system, was the industry’s first chromatography data management system with an integrated Oracle database. This database allows extremely rapid complex searching and reporting of chromatography result information. The result of the partnership with CSols is a powerful, bi-directional interface, which without any need to change software, can be run as a black box system or as an interactive application.

CSols and Waters are already using the new interface to help customers address 21CFR Part 11 compliance issues relating to electronic records, while also supporting core business activities by generating laboratory results faster and more efficiently. Links for LIMS features such as electronic signatures, authority checks, audit trails, archiving and sequenced operation all support Part 11 compliance.

Customers who used to struggle with paper-based, cumbersome and non-compliant systems are now enjoying benefits associated with the system’s multi-user capability, its ability to store both system configuration and data centrally on a server, and the fact that no other software programs need to be invoked.

As Links for LIMS and Millennium32 scale so well together, they can service single analytical laboratories just as successfully as those with many sites and hundreds of chromatographic systems.

“Chromatography data system/LIMS integration has taken a dramatic leap forward,” said CSols CEO Phil Goddard. “Together, Waters and CSols provide the laboratory community with a truly universal solution for integrating Millennium32 software with corporate business systems such as LIMS and ERP,” he added.

CSols is also working with Waters and its Millennium32 software users to develop a suite of plug-and-play interface methods that meet the differing interface requirements of individual laboratories.