July 10, 2012, Billerica, MA — EMD Millipore, the Life Science division of Merck KGaA, Darmstadt, Germany, today 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.
To learn how Millitrack® Compliance can make your water purification system 21 CFR part 11-compliant, and for purchasing information, please contact your local EMD Millipore Application Specialist or visit our website for details: www.emdmillipore.com/MillitrackCompliance
About EMD Millipore
EMD Millipore is the Life Science division of Merck KGaA, Darmstadt, Germany, offers a broad range of innovative, performance products, services and business relationships that enable our customers' success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, EMD Millipore serves as a strategic partner to customers and helps advance the promise of life science.
Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 67 countries an 2010 revenues of $2.2 billion.
Millipore, Millitrack and Milli-Q are registered trademarks of, and EMD Millipore and the M mark are trademarks of Merck KGaA, Darmstadt, Germany.