Webinar: Data Integrity in Pharmaceutical Waters
Seminar

Data Integrity in Pharmaceutical Waters

For Pharmaceutical Manufacturers and Quality Teams

Have you heard of ALCOA and data integrity but are unsure how you can be certain that your water systems are compliant? Get answers in this on-demand webinar.

The webinar begins with an explanation of 21CFR Part 11, including the ALCOA/ALCOA+ framework for achieving compliance. It then introduces the principles of data integrity and electronic record keeping on a pharmaceutical water system.

The presenter concludes with how to "future-proof" your water system with RecordLOC™, a multi-parameter, multi-language data integrity package for TOC, conductivity and ozone that aids in the compliance of electronic record keeping for UPW/WFI water systems. The system is based on well known, and easy to use analytics tools such as the M800 transmitter and the 6000TOCi.

RecordLOC is a two-part data integrity system comprising software and a METTLER TOLEDO M800 2-channel, multi-parameter transmitter with 21 CFR Part 11 compatibility. The RecordLOC system can be configured with any combination of two sensors including TOC, conductivity and/or dissolved ozone. RecordLOC provides a transmitter-stored, encrypted, audit trail; however, all user data is stored on the computer to better comply with the ALCOA+ requirement that data is legible, original and contemporaneous. RecordLOC is unique in that it provides a complete audit trail of TOC as well as conductivity and/or dissolved ozone sensors. This multi-parameter ability is superior to a simple, single-parameter system because it allows users to find and record simultaneous excursions in TOC, conductivity or dissolved ozone, unlike similar solutions that only record TOC and/or conductivity.