The iQue ® software module for 21 CFR Part 11 ensures next-level iQue ® productivity for regulated laboratories. Designed for speed and actionable results, iQue ® is the instrument of choice for busy ...

In 1997, the US Food and Drug Administration issued a regulation"Rule 21 CFR Part 11," that provides criteria for the acceptance of electronic records, electronic signatures, and handwritten ...

On 20 February 2003, the US Food and Drug Administration (FDA) published a new draft guidance relating to 21 CFR Part 11. The new guidance mainly affects the compliance requirements of systems with a ...

A recent report indicated that in 2016, around 79% of 483 warning letters from the FDA to the pharmaceutical industry highlighted weaknesses in data integrity. 1 The FDA outlines its expectations for ...

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced the release of new NovoExpress software that introduces integrated compliance tools for NovoCyte flow ...

Dublin, Nov. 03, 2022 (GLOBE NEWSWIRE) -- The "21 CFR Part 11 Compliance for SaaS/Cloud Applications" training has been added to ResearchAndMarkets.com's offering. This highly interactive two-day ...

DeNovix Inc. announces the launch of EasyApps Secure, a 21 CFR Part 11 Compliance Ready software option for CellDrop Automated Cell Counters. The new suite of controls for EasyApps software enables ...

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Box, Inc. (NYSE:BOX), the leading Content Cloud, today announced that its native e-signature product, Box Sign, has achieved support for compliance with FDA 21 ...

Dublin, Dec. 19, 2023 (GLOBE NEWSWIRE) -- The "21 CFR Part 11 Data Integrity Training for CSV, CSA, SaaS/Cloud - How to Reduce Costs for Compliance" seminar has been added to ResearchAndMarkets.com's ...