The go-to Atlassian experts for pharma and medtech
If you’re in big pharma or medtech, meeting regulations is complex – and that’s before you’ve thrown digital transformation into the mix. Our tight-knit team of dedicated experts specializes in your sensitive regulatory processes. We help you embrace agile working, get the most out of Atlassian tools, while always keeping compliance top of mind.
Discover agile working that works with your regulations
Digital transformation is not the same for your industry – and we know it. We’re super-specialized and experienced in helping organizations like yours to step up processes across your software development life cycle, without losing sight of the strict regulations that govern pharma and medtech development.
And unlike some of our clients, we’re pretty small, so you always get attention from our most experienced team members.
Our Benefits
Expertise
We’re Atlassian experts – experienced at implementing, migrating, and customizing tools to suit our clients’ needs. We know your regulations too – from GxP to ISO 13485.
Communication
We bring your IT leadership and quality assurance and regulatory teams together, to understand their pain points, create and share improvements, and ensure alignment.
Speed
Our specific expertise and breadth of experience helps speed up your implementation, shortcutting your transformation journey so you can hit the ground running right away.
Collaboration
We’re an extension of your team, providing the support you need, the way you need it. Whether that’s a wide scope or a focused project, we’re all working towards the same goals.
Customization
We have the skills in-house to develop custom software extensions for cloud and on-prem Atlassian environments using Atlassian Forge, Atlassian Connect, and Java for DC.
Flexibility
Because each engagement is unique, pay as you go for the precise scope of support you need. There is no commitment to a fixed duration or a predefined capacity.
Embrace Atlassian for your SDLC
We can transfer your requirements and test management workflows into Jira and Confluence, making Atlassian a powerful platform for your software development life cycle and design controls.
Turn Confluence into an eDMS
We can enhance Confluence’s capabilities so it functions as a compliant document management system, including version control and audit trails, access control and permissions, approval workflows, and compliance and regulatory support.
Use Jira to support your QA processes.
We can configure Jira to work as a quality management system, supporting processes like nonconformities and CAPA management, and supplier and complaints management – from customizing workflows and automating approvals to enhancing traceability.
Validate Jira and Confluence
We can make sure your Atlassian tools meet regulatory requirements, validating them for compliance with FDA 21 CFR Part 11 and ISO 13485 – from defining validation protocols to implementing features like audit trails and e-signatures.
Train your teams
We provide mentoring and coaching, helping you to achieve Jira and Confluence validation, quality process automation, and eDMS implementation. We can help teams understand regulatory requirements, implement best practices, and configure tools effectively.
Validation for Atlassian
System validation for Jira and Confluence (Cloud or Data Center) with expert support from a team that understands your needs.
Meet Snapshots
Snapshots of Jira Data into Confluence
Confluence users can see Jira data at the time of each release (whether they have a license or not) and you can control exactly what fields show up in the snapshot – they get the data they need, without all the overwhelm.
And if you’re using Xray for testing, this is the no-code way to configure test reports and traceability matrices in just a few clicks.
See us in action
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Success stories
Lifting a Quality System on Jira and Confluence to a New Galaxy – Ada Case Study
Find out how we helped medical tech company Ada transform its quality processes using Jira and Confluence. The project team tells about the power of tailoring their Quality System on Atlassian.
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Let’s make things easier
Ready to streamline and stay compliant?
Wherever you are on your digital transformation journey, we can help. We know the regulations you need to meet and how to comply without compromising on agility. Get in touch today to find out more.