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ACD/Labs Blog

Sanji Bhal
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.

nvision
How Chemical Manufacturing and Control (CMC) Software Helped a Major Pharmaceutical Company Improve Process Development and Regulatory Submissions Background: In 2019, a process development team at a top biopharmaceutical company felt data management was getting in the way of research and that too much time was spent preparing regulatory submissions. Challenge: The team wanted to...