How to Automate Confluence Cloud Validation

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Medical device companies face a constant challenge: how do you validate cloud software tools that update daily? If you’re using Confluence Cloud for your quality management system, you need validation documentation that keeps pace with Atlassian’s frequent updates.

I’ll walk you through exactly how to automate this process using the SoftComply Validation for Confluence Cloud app, and show you why manual validation simply doesn’t work for cloud tools anymore.

Watch the complete demo to see automated validation in action.

Why Software Validation Matters for Medical Device Companies

In medical device regulations, validation means confirming through objective evidence that your software tool consistently meets its intended use. Basically, you need to prove it does what it’s supposed to do.

ISO 13485 mandates validation of software used for quality management, including both initial validation and revalidation when changes occur. The validation requirements are proportionate to the risk level.

Here’s how the risk analysis works:

1. First, assess if the software tool is part of production or quality system – If yes, you will need to validate the software.
2. Next, determine if software tool is directly used in device production/quality system or merely supports them – Both require validation but at different levels.
3. Finally, evaluate if software failure could create safety risks – High-risk functions need more scrutiny during validation and re-validation.

Analysing the risk of a software tool/feature for validation

The FDA has issued numerous warning letters specifically targeting software tool validation issues. Companies that skip validation face serious nonconformities during audits.

Challenge of Validating Cloud Software Tools

Cloud tools like Confluence Cloud offer amazing benefits – security, scalability, and low maintenance. But they also push daily incremental updates that you cannot opt out of.

Manual validation typically takes weeks to complete. With daily updates to the Cloud software tools, this approach becomes impractical (if not impossible). You’d need a validation team working around the clock just to keep up with Atlassian’s release schedule.

This is where automated validation becomes essential.

How Automated Validation of Confluence Cloud Works

The SoftComply Validation for Confluence app runs periodic integrity checks that produce validation reports with documented evidence like screenshots. You will always have proof of compliance without the manual effort.

Key features:

• 40 tests cover all key Confluence features including user management, space and page management, restrictions and permissions management
• Runs 1 x a week generating full validation documentation after each run
• Runs on dedicated environment (doesn’t affect your data integrity)
• Supports regulatory frameworks like ISO 13485, FDA 21 CFR 11
• Tests Confluence as a black box – the app presses buttons and enters data
• Detects changes in Confluence, including UI changes

When tests fail, SoftComply troubleshoots the failure. If it’s a real Confluence bug, users get notified and we open a ticket with Atlassian. When Atlassian changes the UI (which happens frequently), we update the test cases.

Confluence Cloud Validation Status

Once the Confluence Validation app is installed, you will see the global app page with:

• the dates when the validation tests have been run,
• the status of each validation run, i.e. how many test have passed, failed and been skipped,
• link to the validation documents.

Validation for Confluence Cloud app global page

Complete Validation Documentation Package

After each test run, you get four validation documents:

Master Validation Plan

Describes the scope and process of Confluence Cloud validation, including intended use and risk assessment that determines which features are tested.

Validation Protocol

Details each of the 40 test cases with expected results and step-by-step testing procedures.

Validation Results

Provides detailed test result descriptions with documented evidence like screenshots, showing whether tests passed or failed.

Validation Report

Summarizes how the planned validation activities were executed and completed.

Full validation documentation pack available after each validation run

Confluence Risk Analysis for Validation  

The master validation plan describes exactly which Confluence features we validate and why. It covers:

• Intended use of Confluence for medical device quality system
• Whether Confluence functions are considered high process risk
• If feature failures could compromise medical device safety
• Risk-based determination of which functions require validation testing

Based on this risk assessment, we derived 40 test cases that run during each validation cycle, covering user management, space and page management, permissions, and backup/restore functions.

Validation Results with Objective Evidence

Each of the 40 test cases includes:

• Detailed test case description
• Step-by-step testing procedures (with sub steps where needed)
• Expected results
• Actual test results with screenshots for objective evidence
• Pass/fail status

This documentation provides the objective evidence auditors expect to see, with screenshots proving how each test was actually performed.

Fragment of the Validation Results document

Fragment of one step in a validation test case with time-stamped screenshot for documented evidence

Making Confluence Cloud Compliant for Medical Device Companies

With the SoftComply Validation app, you can confidently use Confluence Cloud for your quality management system documents. The software stays validated automatically, even with Atlassian’s frequent updates.

This solves the fundamental challenge of cloud tool validation – maintaining compliance without the impossible task of manual revalidation after every update.

Ready to see automated validation in action? Try SoftComply Validation for Confluence free for a month or book a live demo to see exactly how it works with your Confluence instance.

For comprehensive risk management solutions beyond Confluence validation, check out SoftComply’s complete product suite.

This article was originally published on SoftComply blog.

[Mia Tamm _Simpleasyty_]

Thanks @Marion Lepmets _SoftComply_ for sharing this detailed walkthrough. The explanation about why manual validation doesn’t work for Confluence Cloud anymore and how automated evidence is generated with screenshots was really clear. I especially liked the risk analysis part. It makes the regulatory context much easier to understand.

— Mia Tamm from Simpleasyty