Merck Millipore, the life science division of Merck, has 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 - US 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.
"Activation of Millitrack® Compliance will enable 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.
Four key features make Millitrack® Compliance a unique e-solution:
Audit trail
- Time-stamped audit trail for full traceability of daily water purification system events
- Up to one year of record storage; protected archiving process
Electronic signature
- Water quality records are saved and signed electronically
- Signature and record permanently linked to prevent falsification
Full system control
- Dynamic, real-time Dashboard displays essential information at a glance
- System components and essential data visible in a mouse click
Account management
- A system Administrator oversees system use, protecting critical information
- Manager, Operator, and Service roles are determined by access needs
To learn more about how Millitrack® Compliance can make YOUR water purification system 21 CFR Part 11-compliant, and for purchasing information, please contact your local Merck Millipore Application Specialist or visit our website for details:
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