Confluence and Jira in Quality Management System
The QMS Built on Tools Your Teams Already Use
Confluence and Jira don’t have to be just your collaboration tools — they can become your compliant electronic QMS.Atlassian tools like Confluence and Jira are widely adopted across industries. These tools gained their popularity for their:- intuitive and user-friendly interface
- fast and straightforward implementation
- scalability and flexibility across teams
- strength in collaboration
Can a QMS based on Confluence and Jira be compliant with ISO 13485, IEC 62304, or FDA 21 CFR 820?
Are electronic records and signatures in Confluence accepted by auditors?
The short answer: Yes!
Confluence and Jira as Your eQMS Compliant Tools
With the right strategy and setup, Confluence and Jira can fully support:- QMS and Quality System Regulation based on ISO 13485 or FDA 21 CFR 820
- IEC 62304 design controls for medical device software
- 21 CFR Part 11 requirements on electronic records and signatures
- Good Documentation Practice (GxP)
Our Expertise Proven in Audits
We have guided numerous medical device companies through ISO 13485 certification audits, FDA inspections under 21 CFR 820, and notified body EU MDR audits.By preparing their Confluence- and Jira-based eQMS with the right configurations, documentation structure, and regulatory anchoring, these companies were able to demonstrate their full compliance with applicable standards and regulations.Our consulting approach ensures that:- audit readiness is built into your daily QMS operations
- Atlassian tools are tailored to meet ISO, IEC, and FDA requirements
- your teams can work confidently in tools they already know and love
Choose the right partner with both regulatory and technical expertise — and ensure your eQMS compliance.
Confluence as a Document Management System
Confluence can be more than a collaboration hub — it can become your compliant, structured, and audit-ready document management system.Teams love Confluence for its simplicity, collaboration features, and intuitive content management. Information flows fast, knowledge is easily shared, and adoption comes naturally.But when it comes to a quality management system (QMS), good operations require more than just content sharing. Documents shall be organized and controlled as defined in the ISO 13485 standard or the FDA 21 CFR 820 regulation.Turning Confluence into a Driver of Operational Excellence
As organizations grow, content in Confluence often expands organically. Without structure, it can become challenging to:- Ensure information is always up-to-date
- Apply a reliable access control process to sensitive information
- Ensure standardized authoring, reviewing, and approving procedures
- Distribute documents effectively to the right audiences
- Controlled versioning (which version was effective, when, and for whom)
- Archiving procedures for historical documents
- Audit trail and logs for regulatory inspections
- Review and approval workflows that ensure accountability
With QML Logic at your side, Confluence goes beyond compliance to deliver the structure every growing organization needs.
How We Support You Make Confluence QMS-Ready
We help organizations design a compliant documentation architecture in Confluence with:- Structured naming convention and versioning system
- Defined archiving process aligned with applicable norms and regulations
- Integration of proven third-party modules for access control, approvals, and audit trails
- Aligned workflows for document reviews, approval, and distribution
Going Beyond Standard Setup
Where standard Confluence features or add-ons are not enough, we build customized solutions tailored to our clients’ needs.You can rely on us when it comes to:- Dashboards for document monitoring and KPIs
- Automation scripts for repetitive or bulk operations
- API integrations for advanced workflows and system interoperability
With the right design, Confluence becomes more than compliant — it becomes fast, convenient, and empowering for your teams.
Jira Across Development, Operations, and Compliance
Jira is widely used both in product development, from requirements engineering, agile workflows, testing, and design reviews, and in operational processes such as complaint handling, incident reporting, and problem resolution. Its flexibility makes it a backbone for engineering teams and support functions alike.From Everyday Use to Regulatory Compliance
What makes this relevant for medical device companies is that these same activities, requirements engineering, verification, complaint handling, and change management, are also core elements of ISO 13485, IEC 62304, MDR, and FDA QSR.At QMLogic, we bring these worlds together:- Configuring Jira for end-to-end traceability from requirements to verification
- Embedding audit trails and controlled electronic records
- Supporting automated generation of technical documentation for regulators
- Closing gaps so that your existing Jira workflows meet regulatory expectations
With QMLogic, Jira evolves from an everyday project tool into a compliant, audit-ready QMS platform.
Beyond Core Jira: Tailored Solutions for QMS
Setting up Jira’s core functionalities is just the first, yet important step. At QMLogic, we help companies go further by integrating third-party modules that extend Jira’s capabilities for:- Requirements engineering and traceability
- Verification and testing activities
- Risk management aligned with ISO 14971
- Build workflow automations using tools such as ScriptRunner or utilising Atlassian’s REST API
- Connect Jira with AI agents and large language models to support QA, consistency checks, and smart content generation
- Develop custom dashboards and review statistics that power KPI evaluation, trend analysis, and management review preparation
- Integrate Jira seamlessly with other systems in your organization, eliminating manual and repetitive work
Atlassian Tools Always Scalable, Always Compliant
With QMLogic, our clients can be certain that every Jira or Confluence setup, including integrated modules, custom workflows, and AI-powered solutions, is fully validated and compliant with the key standards for modern eQMS systems:- ISO 80002-2 – validation of computerized systems
- ISO 42001 – lifecycle management of AI in quality systems
Questions and Answers
Answer:
This depends largely on the size and complexity of your organization:
- For smaller organizations, setting up a QMS in Confluence is straightforward and can often be implemented within days or weeks. It offers an efficient, cost-effective solution for controlled document management.
- As organizations grow in size and complexity, additional requirements on document and record control may emerge. Many companies use Confluence successfully at first, but as their needs expand — e.g., managing contracts, invoices, HR records, and confidential information — Confluence may face limitations in access control, scalability, and information security.
- Up to ~50–60 people, Confluence as an eQMS is easy to set up, maintain, and operate.
- Beyond that scale, especially when hundreds of thousands of documents with different confidentiality levels are involved, maintaining compliance and security can become challenging.
