Lab water purification system is a critical component in pharma, biotech and contract research labs. Merck Millipore’s Lab Water division has unveiled a revolutionary technology to enable regulatory compliance. This solution helps facilitate daily laboratory work as it offers remote monitoring, reduces costs and easy on maintenance, says Vivek A. Par chur, Director – Lab Water, Merck Millipore India Private Ltd, in an email interaction with Nandita Vijay. Excerpts:
Merck Millipore's recently launched Millitrack is considered as a revolutionary product in the lab water purification space. Could you please provide its details?
Yes, the Lab Water division of Merck Millipore recently launched Millitrack Compliance software. This is a novel e-solution designed to enable regulatory compliance for lab water purification system users. Millitrack Compliance is the first water purification e-solution designed to comply with worldwide guidelines on electronic records and electronic signatures, such as USFDA 21 CFR Part 11 and EU Annex 11, or similar requirements set by other global regulatory organizations. It has been designed specifically for the pharmaceutical, biotech and contract research labs that follow GxP regulations which cover good laboratory practices (GLP), good clinical practices ( GCP) and current Good Manufacturing Practices (cGMP). This solution helps facilitate daily laboratory work as it offers remote monitoring, reduction in costs, as there is no room for human error, as well as easy maintenance. The Millitrack Compliance e-solution was launched in India in 2013 end.
Which segment of research is it useful?
The Millitrack Compliance e-Solution is used in laboratory water purification systems. It is an important tool for lab water system users in regulated industries, who wish to comply with global regulatory organization guidelines, such as FDAs Title 21 CFR Part 11. Its key benefits are five:
Firstly, lab users can have real-time as well as remote access to Milli-Q and Elix systems courtesy the system’s Dashboard, which provides information about water purification system status, configuration, instant quality parameters, settings and identification.
Secondly, it archives in a compliant electronic format which can be retrieved easily and efficiently when needed using the powerful, integrated Millitrack Compliance search engine.
Thirdly, Millitrack Compliance e-solution is designed to ensure full compliance with electronic record as per pharmaceutical reporting requirements and can provide data starting at the drug development phase, right through to quality assurance (QA) and quality control (QC) procedures, thereby providing a zero-paper solution.
Fourthly, it is compatible with any lab data management system such as LIMS, ELN, SDMS/ECM
Fifthly, Millitrack Compliance also provides users with a time-stamped audit trail that allows full traceability of all events related to the laboratory’s Milli-Q water purification system: daily water dispensing; system and maintenance operations; event records; consumable changes; and signed service records.
What has been the response so far?
Millitrack software offers users four important key benefits, including full system control, audit trail, electronic signature and account management. The industry has given this offering a warm welcome with some leading pharmaceutical companies already incorporating it into their standard operating procedures (SOPs).
Which markets have evinced interest?
The pharmaceutical and biotech sectors have shown interest in this unique compliance software.
Is this a new product or a new version of an existing product?
The Millitrack Compliance software is a first-of-its-kind system for ultra pure water usage in analytical applications and can be used in combination with Merck Millipore’s Milli-Q and Elix Systems.
What is the competition in the market for this product?
The Millitrack Compliance software is a first-of-its-kind system for ultra pure water usage in analytical applications and has no competition.
What are the future plans of the company?
The Lab Water division of Merck Millipore offers lab water instruments, consumables and services to meet the diverse water purification needs of our customers. The Lab Water division in India is committed to partnering closely with the Indian pharmaceutical industry. In so doing, we would be meeting the industry’s requirements by focusing on providing solutions that will help our customers prove that they are using stringent quality controlled products to test and market products which are manufactured at their sites. For instance, the high-end integral range of products, along with solutions like the Millitrack Compliance software, will help the pharmaceutical industry cope with the stringent audit requirements of the various global agencies because these are the only products which come with the complete validation documents.