For regulated industries – such as Pharma, MedTech, FinTech and Aviation – compliance isn’t optional; it’s mandatory. Tools like Jira and Confluence are powerful, but their true potential is only realized when configured to meet industry-specific regulatory requirements.
This is where industry consultants come into play, offering expertise that goes beyond standard configurations – translating the requirements into the configuration.
- Thorough Regulatory Expertise: Deep understanding of sector-specific regulations and how these can be implemented using the features of modern software tools.
- Customized Solutions: Tailored configurations that address unique compliance requirements and automate organisation’s processes, rather than one-size-fits-all approaches.
- End-to-End Support: From initial setup to ongoing maintenance, consultants offer comprehensive support focused on regulatory adherence.
The Unique Challenges of Regulated Industries
Operating in MedTech, for example, requires compliance with international standards such as ISO 13485, ISO 14971 and IEC 62304, to name just a few. There are also laws and regulations in place for different regions, some specific to Medical Device companies like MDR in Europe, FDA CFR in the US and some across industries (like GDPR in Europe). All these requirements must be considered when building your systems.
SoftComply develops apps for Atlassian Jira and Confluence to help regulated industries with Risk Management and Document Management, and automated Validation of Confluence Cloud.
By tailoring Atlassian tools and SoftComply apps to your organization’s specific needs – through customised Jira workflows, schemas, permissions, data retention settings, and backups – you can create a system that truly supports your internal processes and regulatory obligations.
Industry Consultants: Bridging the Compliance Gap
Industry consultants focus on aligning Jira and Confluence supporting agile development while ensuring regulatory compliance. Here’s how they make a difference:
- Compliance-Centric Configurations: They design workflows that incorporate electronic signatures, audit trails, and validation protocols essential for compliance.
- Integrated Risk & Quality Management: By embedding quality management systems within Jira and Confluence, they ensure that every step is documented and traceable.
- Tailored Training and Support: Understanding that teams need to adapt, these consultants provide customized training to ensure smooth transitions and ongoing compliance.
Watch the Webinar on Agile Risk Management
SoftComply is happy to introduce Aaron Morris from Agile Innovations. They specialize in deploying Jira and Confluence in Pharma and MedTech environments. Agile Innovations offers pre-configured solutions that address compliance gaps, ensuring systems are audit-ready from the outset. Their approach minimizes setup time while maximizing adherence to standards in MedTech and Pharma.
Aaron and his team also run an active YouTube channel “Jira for Life Sciences” where they answer frequently asked questions through practical and insightful videos.
On Jun 5, 2025, Aaron will join SoftComply for a webinar-workshop, where we’ll explore FDA-compliant agile practices – including a live demonstration of continuous Risk Management in the Software Development Lifecycle.
🚀🚀 Watch the webinar here. 🚀🚀
