How to Build a Fully Digital and Audit-Ready QMS in Confluence Cloud - Amiko's Story

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Featuring: Elisa Lo Blanco, QA/RA Manager at Amiko

Relevant for: Atlassian Solution Partners, Confluence/Jira administrators, MedTech software teams, and regulated-industry customers evaluating document control solutions

When digital health innovator Amiko set out to achieve CE marking under the MDR for its respiratory health platform, the team faced a challenge that’s increasingly common across regulated industries:

How do you maintain agile software development while building the structured, traceable, audit-ready documentation regulators expect?

Instead of deploying a complex standalone eQMS, Amiko built their controlled documentation environment directly inside Confluence Cloud, powered by SoftComply Document Manager.

The result was a scalable, intuitive, fully digital Document Management System built on tools their teams already loved - and a blueprint that any Atlassian Solution Partner can replicate for customers in MedTech, pharma, biotech, and other regulated sectors.

Check out the full video interview with Elisa Lo Blanco, QA/RA at Amiko, here:

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1. The MedTech Challenge: Structure Meets Agility

Amiko was transitioning from MDD to MDR and needed to align with:

• ISO 13485

• ISO 14971

• IEC 62304

• IEC/TR 81001-5-1

• IEC 62366

• GDPR and MDCG guidance

At the same time, they wanted to preserve their agile, sprint-based development workflow and avoid burdening engineers with compliance overhead.

This tension is familiar to any regulated software development team today:

• Fast development vs. rigorous documentation

• Decentralized tools vs. unified audit-readiness

• Teams in Jira vs. quality records in disconnected silos

Amiko’s solution is a perfect example of how Atlassian tools - when extended correctly - bridge this gap.

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2. Why Amiko Went Digital Early - and why other regulated teams should too

Amiko quickly realized that the traditional methods (Word, Excel, static SharePoint folders) couldn’t keep pace with their development velocity or MDR expectations.

The common pitfalls of manual document control are:

• Error-prone versioning

• Difficult (if not impossible) traceability during audits

• Scattered documentation

• Developer frustration

• Costly rework

The benefits of digital, integrated document management are:

• Automated version control

• Structured approval workflows

• Always audit-ready

• Real-time traceability across the software development lifecycle

• Dramatically reduced compliance risk

This is a common narrative of many regulated software teams:
Teams want automation, consistency, and tools that reduce audit stress - without learning entirely new platforms.

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3. Why Confluence Became the Foundation of a Compliant eQMS

Amiko’s engineering team already worked heavily in Jira and GitHub. Instead of introducing a disconnected eQMS system, they chose a solution that kept quality documentation inside the tools the team uses daily.

Why SoftComply Document Manager on Confluence Cloud was the perfect fit:

• Minimal learning curve for Jira users

• Pre-validated for medical device compliance

• Built-in ISO 13485–compliant workflows

• Configurable approvals and access control

• Full document locking after approval (critical for regulators)

• Seamless integration with Jira for requirements, risk, and test traceability

• Considerably more cost-effective than standalone eQMS platforms

For Atlassian Solution Partners, this presents a huge advantage:
The customer stays inside the Atlassian ecosystem - and the solution partner delivers a high-value regulated-industry solution without leaving Confluence.

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4. A Repeatable Implementation Approach Partners Can Use

Elisa engaged engineering early in designing the workflow - ensuring strong adoption and reducing the typical friction between QA and development.

The rollout leveraged SoftComply’s built-in structures, requiring no regulatory expertise from the administrators configuring the system.

Key benefits Amiko achieved - benefits any Atlassian Solution Partner can deliver to their regulated customer:

• Ready-to-use validated workflows

• Customizable approval processes

• Automated document versioning and locking

• Zero accidental overwriting

• Full validation documentation pack included

• Jira integration for traceability across the product lifecycle

For customers, this feels natural. For solution partners, it’s a straightforward implementation that unlocks long-term account value.

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5. The Breakthrough Moment: Intuitive Regulatory Controls

One of the biggest revelations for Amiko’s developers was understanding approved document locking - a core regulatory requirement.

SoftComply Document Manager makes this visible, automated, and unavoidable, turning a historically confusing concept into something developers instantly understand.

This is a recurring theme in regulated software teams, best described by Elisa:

Confluence becomes a compliant, audit-ready workspace without slowing down engineering.

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6. Immediate Improvements in Audit-Readiness and Document Control

Within weeks, Amiko saw measurable compliance gains:

ISO 13485 documentation became more structured

• Controlled versions with signatures and history

• Quality records centralized in one environment

Technical documentation became easier to maintain

• Design History File (DHF) evolved naturally

• Automated risk traceability

• Requirements tied directly to verification

Audits became smoother

Auditors praised:

• The structure and clarity of documentation

• The built-in validation of SoftComply Document Manager

• The ease of retrieving evidence

Atlassian Solution Partners often look for tools that win auditor approval - this is one of them.

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7. From Fragmentation to a Unified Source of Truth

Before adopting SoftComply Document Manager, Amiko struggled with:

• scattered files

• inconsistent versions

• outdated documents

• siloed information across Jira, GitHub, SharePoint

After implementation, they gained:

A single ecosystem

Confluence became their documentation hub - backed by live data from Jira.

A cleaner, faster workflow

Developers contribute naturally, QA ensures compliance, and the system enforces structure automatically.

A scalable platform

No siloed document management, re-platforming, or tool duplication needed.

For Atlassian Solution Partners, this makes SoftComply a sticky, long-term value driver within Atlassian user environments.

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8. What Sets SoftComply Apart for Atlassian Users and Partners

When benchmarking options, Amiko evaluated both standalone eQMS platforms and Atlassian-based solutions.

SoftComply Document Manager ranked highest for:

• Cost-effectiveness

• Regulatory validation of the app

• Seamless Atlassian integration

• Ease of developer adoption

• Support for agile practices

SoftComply enables:

• MDR & ISO 13485–ready document control

• Automated traceability from requirements to risks to testing

• Always audit-ready documentation

• Zero friction for Confluence and Jira users

• Scalable growth as companies mature

For Solution Partners:
This is a differentiated offering with strong market pull and minimal delivery complexity.

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9. A Replicable Model for Any Regulated Atlassian Customer

Amiko’s context is specific, but the model is universal.

Any company developing software in a regulated environment can:

• Build their QMS directly in Confluence

• Use SoftComply Document Manager as a validated eDMS

• Link documentation to Jira workflows

• Maintain real-time traceability

• Manage their risks in Jira with SoftComply Risk Manager Plus

• Keep teams compliant without slowing them down

Partners can position this as a clear, repeatable package.

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10. Why Atlassian Solution Partners Should Care: A Growing Vertical With Clear Need

Digital health, MedTech, biotech, and regulated software companies are all accelerating adoption of Atlassian Cloud.

Many are now looking for:

• Digital QMS

• Document control

• Requirements ↔ risk ↔ test traceability

• Auditor-friendly workflows

• Tools that engineers will actually use

SoftComply gives partners a turnkey solution to meet this demand - with high customer value and strong ecosystem alignment.

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Final Reflection From Amiko

As Elisa, QA/RA at Amiko puts it:

“SoftComply proved to be a reliable and highly knowledgeable partner for integrating compliance into the way our team actually works.”

The takeaway is clear:

Compliance doesn’t need its own platform - it just needs better workflows in the tools customers already trust.

SoftComply Document Manager brings:

• Regulatory structure

• Embedded compliance

• Compliant document control

• Audit readiness by default

All inside Confluence Cloud.

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Want to Bring This Offering to Your Team?

Whether you're an Atlassian Solution Partner or an internal Atlassian champion, you can explore how SoftComply works in practice:

👉 Book a live demo with SoftComply team
https://calendly.com/softcomply/softcomply-intro

👉 Start a free trial in Confluence Cloud
https://marketplace.atlassian.com/apps/1231336/softcomply-document-manager-for-advanced-document-management?hosting=cloud&tab=overview

This is a scalable, partner-ready solution your regulated customers will immediately understand.

Full case study with Amiko was originally published on SoftComply blog.