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:
Agile eQMS to Move Faster & Break Nothing
Our customer Orthogonal describes how to set up an agile eQMS solution on Atlassian Confluence and Jira
SoftComply Risk Manager vs Risk Manager Plus on Jira Cloud
Comparison between the risk management apps on Atlassian Jira – the SoftComply Risk Manager and the Risk Manager Plus on Jira Cloud
In Search of a Compliance Solution that Lets You Sleep at Night
How to find the best regulatory compliance solution for medtech on Atlassian
Software Validation: A Comprehensive Approach to Software Validation in the Medical Device Industry
Automated Validation of Confluence Cloud
On the New FDA Guidance on Software Assurance
On September 13 2022, the FDA issued a new draft guidance on “Computer Software Assurance for Production and Quality System Software”. This new guidance is intended to supplement the current approach described in the 2002 “General Principles of Software Validation” guidance. This guidance additionally discusses specific risk considerations, acceptable testing methods, and efficient generation of […]
How to Maintain a Documentation Baseline of Agile Development in Confluence?
most popular use cases for capturing and freezing the always dynamic data in Confluence with the SoftComply Static Snapshots app
Change Management & Medical Device QMS on Confluence
How to keep your QMS up to date when regulations and standards change over time with the help of a Compliance Matrix
Display Document Approvals on Confluence Pages with the SoftComply Change History app
display your document approval history on Confluence pages with the SoftComply Change History app
Introducing the Cloud eQMS Solution for Confluence
Why Confluence? Or perhaps the first question should be – why quality management? Most medical device companies need to have a compliant quality management system in place to assure consistent quality of their product. Quality management system consists of a number of written procedures and a multitude of records that will be generated during the […]
