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Key highlights of the appAutomated Validation App for SoftComply Risk Manager Plus
Weekly Automated Validation of Risk Manager Plus
Weekly validation tests are executed automatically, and results are made available for download. The Validation app includes automated tests on the main functionalities related to the risk models and risk tables.
Validation Report with Test Cases & their Statuses
Test Protocol & Test Report list all the tests that are run by the Validation app. Test Report indicates if the test case has passed or failed.
Test Results include Documented Evidence
The test results include the description of each test case with the expected result and a screenshot as documented evidence together with the status, i.e. pass or fail.
Supporting media
More details
SoftComply Validation for Risk Manager Plus tests the functionality of the Risk Manager Plus through automated checks generating validation reports with documented evidence.
The Validation App for Risk Manager Plus collects evidence of the continued data integrity of Risk Manager Plus app.
Validation is a key requirement for safety-critical industries e.g. MedTech, aerospace, automotive, etc.
The approach of continued automated tests provided by this app aligns with the latest FDA guidance of Computer Software Assurance for Production and Quality System Software, Part V Section C.
The Validation App also supports compliance with the requirements of ISO 13485:2016 Clause 4.1.6 and FDA 21 CFR 11.
Validation app for Risk Manager Plus generates four documents after each test run: Master Validation Plan, Validation Report, Test Protocol and Master Validation Report.
Book a DEMO CALL to learn more.
Resources
App documentation
Comprehensive set of documentation from the partner on how this app works
EULA
Get the End User License Agreement for this app
Privacy and Security
Privacy policy
Atlassian's privacy policy is not applicable to the use of this app. Please refer to the privacy policy provided by this app's partner.
Partner privacy policySecurity program
This app is not part of the Marketplace Bug Bounty program.
Version information
Version 5.12.0•for Confluence Cloud
- Release date
- May 17th 2025
- Summary
- Minor version update
- Details
- Minor version update
- Payment model
- Paid via Atlassian
- License type
- Commercial