Unique Lab Water E-Solution Introduced: Millitrack® Compliance

11 Jul 2012

Product news

Merck Millipore, the Life Science division of Merck, announced the introduction of Millitrack® Compliance, a novel e-solution designed to enable regulatory compliance for lab water purification system users.

This unique fully-embedded water purification system software has been developed especially for the pharmaceutical, biotech and contract labs that follow GxP regulations (GLP, GCP or cGMP – U.S. Food and Drug Administration [FDA] regulations), and which are required to conform to FDA Title 21 CFR Part 11 guidelines — or similar requirements set by other global regulatory organizations. Millitrack® Compliance offers users four important key benefits, including full system control, audit trail, electronic signature, and account management.

“Activation of Millitrack® Compliance will allow full Milli-Q® water purification compliance with 21 CFR Part 11 record saving, electronic signature and auditing criteria guidelines,” explains Eric Beguec, Lab Water service and validation product manager. “The software has a user-friendly graphical interface that provides lab personnel with key water system information, either through a point-to-point computer or direct network connection using TCP/IP Ethernet protocol. For even greater flexibility, users can also monitor water system operations at any time through a web browser,” he adds.

“The Lab Water business field recognized early on that there was a strong need among our customers to have access to an electronic data management platform compliant with 21 CFR part 11,” notes Lab Water group product manager, Jean-François Pilette. “We designed Millitrack® Compliance to make lab water system compliance easy for our customers working in regulated environments,” he adds.

Merck Millipore are having a special live Millitrack® Compliance Webinar on Pharmaceutical-technology.com on July 17 or 18. Hosted by the Merck Millipore Lab Water Business Unit, the webinar is entitled “Application of 21 CFR Part 11 with Millitrack® Compliance for your Water Purification Systems” and will feature industry experts, Dr. Ludwig Huber, Chief Advisor – Global ISO® 17025 and FDA/EU Compliance, and Eric Beguec, Lab Water Service & Validation Product Manager.

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Water PurificationThere are a number of water purification methods available to remove contamination from laboratory water. These systems include demineralization, reverse osmosis, filtration and ultrafiltration. A combination of methods is sometimes necessary to achieve purified water suitable for use in experiments.Water AnalysisAnalytical methods used to test the purity of drinking water include determining the level of contaminants abides to the level set by the Environmental Protection Agency (EPA).
Unique Lab Water E-Solution Introduced: Millitrack® Compliance