STUDIUS: Application Note

Introducing Continuous Audit Mode (CAM) on Solentim’s STUDIUS™ data management platform

Why a Part 11 ‘mind set’ should be a foundation to every cell line development workflow

Scientists and Quality Managers working in the clinical manufacturing of therapeutics will be familiar with the Part 11 regulations. These either regulate, in the case of the US FDA Part 11, or are key guidelines to compliance as in the case of EU Annex 11. In both cases they describe the requirements for computer systems and digital signatures within cGMP regulated pharmaceutical environments.


In this document, Solentim describes why it is important to adopt a Part 11 'mind set' and how STUDIUS, a data management system designed for cell line development processes, accommodates the requirements of Part 11 regulations.




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