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.