PART 11 FILE MONITOR MANUAL
PART 11 FILE MONITOR SERIES

The electronic record may be kept safely and securely, but the data it contains may not be correct, or may simply be missing!

PART 11 FILE MONITOR MANUAL

A manual SOP is where the instrument set-up and configuration is performed manually by the user or where the QC test results are manually transcribed into electronic record format.

One area however still very much remains a concern: the potential for affecting the integrity of Quality Control (QC) test result data by human error through the use of manual Standard Operating Procedures (SOPs). The introduction of the FDA’s Guidance for Industry Part 11, Electronic Records Electronic Signatures prompted the pharmaceutical industry to take a closer look at how it stored and controlled electronic records. This paper describes how Quality Control instruments can be optimised for pharmaceutical use, helping to improve the integrity of the data in the final electronic record. With manually implemented Standard Operating Procedures for Quality Control testing and manual transcription of the test results still common practices in the pharmaceutical QC world, the resultant opportunities for human error raises concerns over the integrity of the data in the final electronic record, no matter how safely the final record is stored. The FDA’s 21CFR part 11 guidance1 on the use of electronic records for data retention or submission is clear.

PART 11 FILE MONITOR SERIES

CytoFLEX Violet-Blue-Red Series Upgrades.Biomek NGeniuS Next Generation Library Prep System.Navios EX – Powerful, Dependable Flow Cytometer.

Part 11 file monitor