Millitrack® ComplianceThe e-Solution today for the regulated lab of tomorrowMillitrack® ComplianceThe e-Solution today for the regulated lab of tomorrow

Merck Millipore is a division of

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Activation of the Millitrack® Compliance e-Solution, along with use of Merck Millipore’s unique water system workbook protocols, will enable Milli-Q® Advantage and Milli-Q® Integral users to fully comply with regulatory guidelines.

Millitrack® Compliance is an important tool for lab water system users in regulated industries everywhere who wish to comply with record-saving, electronic signature and auditing criteria defi ned by

global regulatory organization guidelines, such as the FDA’s Title 21 CFR Part 11.

The Millitrack® Compliance e-Solution has been developed in accordance with ISPE Good Automated Manufacturing Practice (GAMP®), and a complete Merck Millipore Validation Package makes compliance easy.

In regulated industries today, records must be kept for a minimum of seven years, and often as long as 40 years. These archiving practices not only impact the cost of data, but also can have an effect on data integrity.

Records archived in a compliant electronic format can be retrieved easily and effi ciently when needed, using the powerful, integrated Millitrack® Compliance search engine. Quick and

accurate document retrieval can also help expedite acceptation by regulatory bodies.

To ensure full compliance, an electronic record must be in line with pharmaceutical reporting requirements. Designed to fi t this need, Millitrack® Compliance can be used to provide data starting at the drug development phase, right through to QA and QC procedures.

As laboratories continue to move toward paperless solutions, laboratory equipment manufacturers have developed new technologies for storing data and signing documents. Millitrack® Compliance is the fi rst water purifi cation e-solution designed to comply with worldwide guidelines on electronic records and electronic signatures, such as U.S. FDA 21 CFR Part 11* and EU Annex 11**, or similar requirements set by other global regulatory organizations.

The Millitrack® Compliance e-Solution helps optimize laboratory performance and decrease downtime thanks to e-records and enhanced monitoring and diagnostic features.

*Part 11 of Title 21 of the FDA Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11 ).** EudraLex - Volume 4 Annex 11 Good manufacturing practice (GMP) Guidelines.

Full compliance

Zero-paper solution

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Ensures traceability

Minimizes downtime, optimizes productivity

* Not available in all regions. Please check with your local Merck Millipore office for information about your area.

Millitrack® Compliance provides users with a time-stamped audit trail that allows full traceability of all events related to the laboratory’s Milli-Q® water purifi cation system: daily water dispensing; system and maintenance operations; event records; consumable changes; and signed service records.

Only Millitrack® Compliance authorized users are able to electronically sign and date water quality records, thereby ensuring secure long-term archiving. The signature and the record are permanently linked to prevent any possibility of document falsifi cation, and the signed, time-stamped electronic records can be archived on a hard drive or a secured server, providing total control over both current and archived data.

If the water purifi cation unit is shared by several labs, Millitrack Compliance® software makes it easy to determine the costs of water usage for each lab and/or individual user.

Up to one year of records can be stored in the water purifi cation system’s memory, which stores and indexes all data related to Milli-Q® system events. The powerful Millitrack® Compliance search engine can be used to fi nd data whenever you need it on a daily basis, or also to retrieve data for use during audits. The basic search function allows records to be located very easily, and advanced search functions can be used for complex queries.

The integrity of archived data is guaranteed by a double protection: an electronic signature and a checksum for each record.

Full system controlThe intuitive Dashboard enables authorized users to see operating information at a glance, giving them full control over system operation, and making it possible to take any steps necessary to ensure continued optimal operation of their water purifi cation system.

In addition to making compliance easy, the Millitrack® Compliance e-Solution is also designed to facilitate work in the lab and boost lab productivity by giving you complete control over Milli-Q® Advantage and Milli-Q® Integral water systems.

Advanced remote diagnosticsMillitrack® Compliance also offers users a unique advanced remote diagnostics service*. When faced with an alarm or system issue, you can export a complete diagnostic report of your water system. This report, which is protected by a password known only to Merck Millipore, can be sent to your local Merck Millipore Lab Water Technical Service Representative. This data will assist the Service Representative in providing a faster diagnostic of your problem so that you experience minimal downtime.

Easy maintenanceWhen Millitrack® Compliance is activated on your Milli-Q® water purifi cation system, replacement of system consumables and other maintenance tasks are easier than ever: an automated assistant along with embedded step-by-step procedures help guide the user whenever any maintenance tasks must be performed. This facilitates daily work, saves time and prevents errors.

www.merckmillipore.com/labwater

Millipore, Millitrack and Milli-Q are registered trademarks of Merck KGaA, Darmstadt, Germany. Merck Millipore and the M mark are trademarks of Merck KGaA.GAMP is a registered trademark of the International Society for Pharmaceutical Engineering. Microsoft, Windows, Internet Explorer and Silverlight are registered trademarks of Microsoft Corporation. Lit. No. PB4277EN00© Copyright 2013 EMD Millipore Corporation, Billerica, MA, U.S.A. All rights reserved.

Smooth implementation

Millitrack® Compliance specifi cations

Getting started with Millitrack® Compliance

IT policies can sometimes restrict the use of certain software. This is not a problem for Millitrack® Compliance: the e-Solution is intelligently embedded within the Milli-Q® water purifi cation system, meaning that no software needs to be downloaded in order to access Millitrack® Compliance functionalities. Implementation is easy — even in the most secure of IT environments.

Using Millitrack® Compliance, all of the water system operations can be monitored at any time on any computer through a one-click web browser. In addition, Millitrack® Compliance allows data archiving in Open XML format compatible with most laboratory data management systems.

To purchase Millitrack® Compliance, just contact your local Merck Millipore Application Specialist or visit our website today: www.merckmillipore.com/millitrackcompliance

Computer & network connectionNotebook/Desktop PC, recommendedminimum confi guration

1GHz processor512MB RAM

Operating system Microsoft® Windows® XP operating system (SP3)Microsoft® Windows® 7 operating system (SP1)

Web browser Internet Explorer® 6, Internet Explorer® 7Internet Explorer® 8, Internet Explorer® 9

Web technology Microsoft® Silverlight® 4 web browser plug-in