Why Should Validation Work Silently in the Background?
Validation of software tools often leads to significant confusion as regulations mandate it but companies are often still unclear how to approach it. Validation is a regulatory requirement for safety-critical industries e.g. MedTech, aerospace, automotive. What is Validation? In essence, validation is the critical process of assessing a software tool to ensure it aligns with […]
Demystifying Software Tool Validation
Ever wondered why software tool validation is crucial in the medical device industry? With modern medical regulations putting more emphasis on the management of software tools, it’s become an important part of the puzzle. Companies use various applications in the lifecycle of a device, and they must ensure they work as expected, based on how […]
End App Fatigue with one Risk Management Solution
For decades organisations have been struggling with working in silos with different departments working with several stand-alone software tools, each for a specific task. With tools like Jira and Confluence that cater to a variety of different needs you can set up your entire organisation on one platform. So, there should be no more complaints? […]
Changes of Confluence Cloud in 2023: Detected by SoftComply
Confluence Cloud is constantly changing and not all the changes that are implemented by Atlassian are gated, i.e. they can’t be verified over the 2 weeks of Atlassian Release Tracks. SoftComply Validation app for Confluence Cloud is developed to monitor changes in and ensure the data integrity of your Confluence instance. The Validation app for […]
Data Integrity of Confluence Cloud
Ensuring Data Integrity of your Confluence Cloud instance with the SoftComply Validation app when Migrating from Confluence Server to Cloud – Automated Testing of Atlassian Confluence Migrating from Confluence Server to Confluence Cloud can be a complex process, especially when it comes to ensuring data integrity and maintaining validation status. Data integrity is a critical […]
Validation of Confluence Cloud
What to validate in your Confluence cloud instance and how to do it
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:
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 […]
