Waters Corporation has signed a cooperative marketing agreement with Taratec. Under the terms of the agreement, Waters will extend the capabilities of its Connections Compliance Services for chromatography instruments and software by adding the global computer systems validation and 21 CFR Part 11 expertise of Taratec.
This partnership is designed to provide Waters' customers with a proven approach to achieving compliance with FDA (Food and Drug Administration) and ICH (International Conference on Harmonisation) requirements, by complementing the existing suite of Waters'qualification services with a portfolio of compliance services designed specifically for those HPLC (High Pressure Liquid Chromatography) systems that operate in a networked environment. This is of critical importance given the recent increase in the frequency, breadth and depth of FDA inspections coupled with the need for life science laboratories to integrate and analyze instrument data across enterprise-wide computing environments.
"We are constantly seeking ways to improve our ability to assist customers in meeting their regulatory compliance objectives" said Rohit Khanna, vice-president of strategic business at Waters. "Taratec has an established track record in developing and implementing compliance strategies in a networked environment. This agreement takes an already excellent working relationship with Taratec and formalizes it into one that will allow Waters to extend its Compliance Services by connecting customers with proven validation consulting and services professionals."
"This partnership of industry leaders represents an exciting opportunity for Taratec," said Bill Gargano, president and COO of Taratec. "With the proven stability of Waters chromatography applications and qualification services coupled with Taratec's established compliance expertise, we will be able to offer a comprehensive solution that will allow life science laboratories to have a compliant, fully integrated instrument network in a minimum of time."
This partnership extends an existing agreement adopted by Waters and Taratec in 2000 which recognizes Taratec as a Premier Partner with the Waters Software Partnership Program for the integration of Millennium32 and Empower software into commercial and in-house developed LIMS (laboratory information management systems).
Regulatory compliance for life science companies requires adherence to all government regulations for the development and manufacture of safe and effective products including drugs and medical devices. Achieving compliance for laboratory analysis systems and software requires documented evidence that they are developed and implemented according to quality software engineering principles, provide the functional capability required by its users and the associated government regulations, and that they will continue to do so over time. Waters, by providing compliance-ready instruments, software, and qualification services together with Taratec's global solutions for addressing corporate compliance requirements, will assist customers in meeting the highest levels of regulatory compliance.