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

2

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

3

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 control

The 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 diagnostics

Millitrack® 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 maintenance

When 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 connection

Notebook/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

The Deputy Director of the Plentzia Marine Station is Dr. Manu Soto, former Associate Dean of the Faculty of Science and Technology (2007-2012), and researcher in the Department of Zoology & Animal Cell Biology at the University of the Basque Country. In a recent interview, he described the activities at the Plentzia center, as well as the importance of high purity water in his researchers’ work.

“Members of the ‘Cell Biology in Environmental Toxicology’ research group, now based at the Plentzia Marine Station, have worked together since the mid-1980s,” Dr. Soto explains, “and the participants attained consolidated research group status in 2001.”

The group’s research concerns basic and applied Cell Biology in Environmental Toxicology, both on land and in the water, and focuses speciically on:

▼ Effects of pollutants at the molecular, cellular, tissue, and organismic levels

▼ Development of biomarkers for pollution monitoring programs

▼ Development of toxicity tests (lethal, sub-lethal, in vitro genotoxicity)

▼ Distribution of contaminants in natural systems

▼ Contaminant uptake, accumulation, distribution and metabolism in sentinel organisms

The research group has well-equipped facilities that include both a histology and a molecular biology lab, together with cell culture rooms and image analysis facilities. “We try to approach all of our research using high quality standards that follow good laboratory practices,” says Dr. Soto. “Our research is focused on cell and molecular biology and we do a lot of cell culturing with invertebrate cells. For these reasons, we want to ensure the quality of all the consumables we use, including ultrapure water.

“In July 2012, after more than six years of construction, we opened the new Research Center for Experimental Marine Biology and Biotechnology in Plentzia Marine Station near Bilbao. In the marine station, our primary objective is to ensure that we conduct high-quality experimentation under controlled lab and ield conditions.”

Merck Millipore pure and ultrapure water systems meet marine biologists’ high quality standardsThe Plentzia Marine Station, near Bilbao in northern Spain, houses the brand-new Research

Center for Experimental Marine Biology and Biotechnology. In the Center, which is part of

the University of the Basque Country, researchers from the Department of Zoology & Animal

Cell Biology use Merck Millipore’s pure and ultrapure water systems to conduct world-class

experimentation under controlled laboratory and ield conditions.

Merck Millipore is a division of

Plentzia Marine Station near Bilbao, Spain

For more information about Merck Millipore: www.merckmillipore.com/labwater

For more information about the University of the Basque Country: www.ehu.es www.ehu.es/GrupoBCTA

For more information about the Plentzia Marine Station (PIE): www.ehu.es/PIE

Millipore, Elix, Milli-Q, BioPak, Millipak, Q-POD and E-POD are registered trademarks of Merck KGaA, Darmstadt, Germany. Merck Millipore and the M mark are trademarks of Merck KGaA.© 2013 EMD Millipore Corporation, Billerica, MA, U.S.A. All rights reserved.

The group’s research focuses on phenomena in the areas of cell biology, molecular biology and genetics, experimental physiology, toxicology and pathology, stress biology, systems biology and biopharmacy. Members use advanced manipula-tion and experimental techniques for their work with marine organisms, in vitro assays, genomics, proteomics, antibody tech-nology, cryotechnology, spectroscopy, microscopy, image analysis, and data treatment.

“The facilities in Plentzia are completely new,” Dr. Soto continues, “and we wanted to take advantage of this fact to avoid the installation issues that had been a problem in our old laborato-ries. This is why we decided to contact Merck Millipore for help in designing the pure and ultrapure water installation that would best it our needs today.

“We purchased a Milli-Q® Integral 5 system, and installed this new system, as well as a 60-liter reservoir, in a laboratory washing area. This Milli-Q® system feeds a Q-POD® ultrapure water dispenser with a BioPak® ultrailtration polisher (for pyrogen- and nuclease-free water) in our molecular biology lab, and an additional Q-POD® dispenser, along with an E-POD® pure water dispenser, in the adjacent histology lab.”

This E-POD® dispenser and second Q-POD® dispenser are both itted with Millipak® point-of-use polishers to provide bacte-ria-free and particulate-free water. In addition, pure water from the reservoir is used to manually feed small autoclaves in the washing room — and in the near future, the Center also plans to connect a washing machine directly to the reservoir.

Several other Merck Millipore systems also have been installed in other areas of the Center, including a Milli-Q® Integral 3 system with E-POD® and Q-POD® dispensers in the clean room, and two Elix® Advantage 3 systems — one in the microbiology lab, and the other in the autopsy room.

“During the selection process, we chose Merck Millipore over competitors for the Plentzia project because we knew the services provided by Merck Millipore are high class, and fulill all the quality standards that we want to ensure in our daily work,” says Dr. Soto.

“Before we decided on the systems for our new lab facilities, we worked closely with two Merck Millipore Application Specialists to evaluate our needs. The assistance they provided was fantastic, and absolutely professional. They gave us all the information we needed, and took the time to explain it so that it was easy to understand. More importantly, their help was pivotal in our inal choice concerning the pure and ultrapure systems we chose for Plentzia — I must admit that I learned a lot from them.

“In summary, I’d surely recommend Merck Millipore’s water puriication systems to other researchers working in life science labs,” concludes Dr. Soto. “Not just for their highly reputed sys-tems, but also for the invaluable help provided by their experts.”

Histology lab, with Q-POD® ultrapure water and E-POD® pure water dispensers,

fed by a Milli-Q® Integral 5 system installed in the adjacent washing room

Washing room with Milli-Q® Integral system and 60 L reservoir, supplying

ultrapure and pure water to the Q-POD® and E-POD® dispensers in the histology lab,

and ultrapure water to an additional Q-POD® dispenser in the molecular biology lab

Microbiology lab, with E-POD® pure water dispenser fed from an Elix® Advantage

system and 10 L reservoir installed under the bench