Tag: "quality-management"

Managing Quality Management System (QMS) compliance has traditionally been a complex and time-consuming task. Ensuring compliance with ISO 9001 standards, conducting internal audits, and mitigating q...

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There are some electronic records that a medical device manufacturer can easily manage in Confluence while others require a compliant document management solution. This post describes which records f...

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• confluence-cloud
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• fda
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This case study describes the experience of a multinational medical device manufacturer meeting the FDA cybersecurity requirements. The company is operating in the MedTech sector developing a class 2...

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Join us on September 11th at 4pm CET for an online webinar on Document and Quality Management in Confluence & how to validate your Confluence Cloud instance. 

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• quality-management
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Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11, deals with the requirements for Electronic Records and Electronic Signatures to be considered “trustworthy” by the FDA. ...

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