Empower Tips: Ask Me Anything About Configuring Empower Software to Maximize Your Compliance
There are GxP regulations specifically relating to the controls required for the use of electronic records, electronic signatures, and computerized systems. These regulations require a combination of procedural, technical, and behavioral controls to achieve full and ongoing compliance.
It is important for Quality Units and regulators to understand the capabilities available for processing data and, the need for varied levels of flexibility within the Empower Software Solutions based on the chromatography and types of molecules being analyzed. There can be a perception that analysts may use Processing Method parameters or manual integration to introduce human bias, or even “polish results” in a way that would cause otherwise out-of-specification (OOS) samples to pass laboratory test requirements such as assays and impurity methods. To fully ascertain what is happening in the laboratory, both the Quality Unit and regulators should be fully aware of how an organization utilizes the Review window to optimize Processing Method parameters.
In this webinar we will examine the current system policies and privileges in Empower Software that affect what analysts can and cannot do when processing data, particularly in Review.
Please join us for a live discussion. As always, don’t forget to bring your questions for this exclusive opportunity to ask our experts anything about Empower Software.
Presenter: Neil Lander (Principal Product Manager - Informatics Group, Waters Corporation)
Neil has worked for Waters Corporation since 1994 and has held a variety of positions including Technical Support Specialist, Technical Trainer, Manager Customer Education and currently, Principal Marketing Manager in Waters in the Informatics group. Neil provides internal support for Empower CDS software and is focused on developing laboratory software solutions that help organizations achieve their scientific and operational objectives. Prior to joining Waters Corporation, he was an analytical chemist where he gained experience in both the cosmetics and specialty chemical industries.
Presenter: Nisar Ahmed (Empower Applications Consultant, Waters Corporation)
Nisar joined Waters Corporation in 1998 and has held a variety of technical positions including Technical Support Specialist, Customer Education Manager and currently Empower Applications Consultant. Nisar works with Waters as an Informatics Consultant. His current role is to act as a resource across Europe providing support, consultancy and training to laboratories implementing and/or using Empower Software as their CDS in a compliant and regulated environment. Nisar joined Waters after a career in the pharmaceutical industry as an analytical chemist. He also holds a Master of Science degree from the University of London.
