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What are the FDA 21 CFR 11 Compliant Electronic Records?
Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11,…
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What is an FDA 21 CFR 11 Compliant Electronic Signature?
Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11,…
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Managing Documents in the 21st Century
INTRODUCTION Although paper records still have their place in the modern industry, most companies use one…
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Demystifying Software Tool Validation
Ever wondered why software tool validation is crucial in the medical device industry? With modern medical…
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Don’t Leave Your Quality Team Behind!
Your Development team might find the instructions from Quality and Compliance team time-consuming – slowing down…
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Turning Confluence Cloud into a Compliant Document Management System
SoftComply Document Manager is the newest Confluence Cloud app for managing documents with dedicated Workflows and…
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The Document Management Solution You Have Been Waiting For: THE SOFTCOMPLY DOCUMENT MANAGER
TL;DR INTRODUCTION Choosing the appropriate document management system for your company is a critical task. You…
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Validation of Confluence Cloud
What to validate in your Confluence cloud instance and how to do it
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Software Tool Validation in the Medical Device Industry – A White Paper
WHITE PAPER ON REGULATORY REQUIREMENTS AND BEST PRACTICES FOR VALIDATION For More News on Validation:
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Agile eQMS to Move Faster & Break Nothing
Our customer Orthogonal describes how to set up an agile eQMS solution on Atlassian Confluence and Jira
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In Search of a Compliance Solution that Lets You Sleep at Night
How to find the best regulatory compliance solution for medtech on Atlassian
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On the New FDA Guidance on Software Assurance
On September 13 2022, the FDA issued a new draft guidance on “Computer Software Assurance for…