FDA Software Assurance
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:
Orthogonal-Agile-eQMS
Agile eQMS to Move Faster & Break Nothing
Our customer Orthogonal describes how to set up an agile eQMS solution on Atlassian Confluence and Jira
Skinuvita Team Tablet© Skinuvita copy
In Search of a Compliance Solution that Lets You Sleep at Night
How to find the best regulatory compliance solution for medtech on Atlassian
Risk
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
Validation
Software Validation: A Comprehensive Approach to Software Validation in the Medical Device Industry
Automated Validation of Confluence Cloud
FDA Software Assurance
On the New FDA Guidance on Software Assurance
On September 13 2022, the FDA issued a new draft guidance on “Computer Software Assurance for…
Capture&Freeze
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
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 approval
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
Cloud_eQms_logo_Final-02
Introducing the Cloud eQMS Solution for Confluence
Why Confluence? Or perhaps the first question should be – why quality management? Most medical device…
Traceability-report
How to Create a Risk Traceability Matrix in Jira
Introduction Risk Traceability is a great way to get a quick overview of the completeness of risk…
Create-New-selection
Risk Management in Jira: Streamlining the Process with Powerful Tools
Risk Management in Jira In today’s fast-paced and ever-evolving business landscape, effective risk management plays a…