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The completeness, consistency and accuracy of data is of ever-growing importance in the pharmaceutical industry. This white paper explains how the ALCOA+ framework is designed to ensure data from equipment used in drug manufacturing is of the greatest integrity.
METTLER TOLEDO provides a tool to help your water system be in compliance with the highest standards for electronic record keeping.
In order to meet the requirements of ALCOA+ with regard to electronic record keeping and data integrity for pharmaceutical waters, METTLER TOLEDO Thornton has developed the RecordLOC™ data integrity package. RecordLOC is a two-part system comprising a PC software tool and a METTLER TOLEDO M800 2-channel, multi-parameter transmitter with 21 CFR Part 11 compatibility.
The 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 PC to better comply with the ALCOA+ requirement that data is legible, original and contemporaneous. Additionally, the solution is based on well-known and trusted METTLER TOLEDO instruments such as the 6000TOCi, UniCond® and pureO3™ sensors, combined with the M800 transmitter. This provides very high confidence in measurement accuracy and water system control.
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