- Fully-embedded water purification system software makes compliance possible for Milli-Q® system users
- New software provides audit trail, e-signature, full system control, and account management
- User-friendly, flexible graphical interface provides key water system information
July 10, 2012, Billerica, MA -EMD Millipore, the Life Science division of Merck KGaA of 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.
For more information, please join EMD Millipore on Pharmaceutical-technology.com on July 17 or 18 for a special live Millitrack® Compliance Webinar. Hosted by the EMD 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. Register now on http://www.millipore.com/MillitrackCompliance for the webinar in your time zone (NA/EU/PANASIA).
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: http://www.millipore.com/MillitrackCompliance.
About EMD Millipore
EMD Millipore is the Life Science division of Merck KGaA of Germany and 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 and 2011 revenues of EUR 2.4 billion. EMD Millipore is known as Merck Millipore outside of the U.S. and Canada.