GxP and 21 CFR Part 11 Compliance
There are a number of common misconceptions about software in validated environments. Many arise because previous deployments of software accompanied the installation of new hardware, or have involved informatics systems that are the source of data and reports submitted directly to regulatory authorities. Here we clear up some of the grey areas that seem to have become industry myths.
The Digital Transformation of MilliporeSigma’s Reference Materials
MilliporeSigma’s ChemisTwin™ leverages NMR Workbook Suite technology in the digital transformation of their industry-leading library of reference materials. The platform streamlines analytical testing, promising unprecedented efficiency, and accessibility.
ISO10993:18-2020—Simplifying the Chemical Characterization of Medical Device Materials
Chemical characterization of E&Ls in medical devices is integral to safeguarding the safety of medical products. The ISO10993-18:2020 guidelines provide comprehensive guidance to help address the fundamental questions “What substance(s) may be released from drug packaging or medical devices?” and “Will it cause harm to patients?”