A mid-sized company in the medical technology sector faced a growing challenge: meeting the stringent requirements of the Medical Device Regulation (MDR) and FDA 21 CFR. As the company expanded, the existing ways of managing risks and documentation – such as Excel spreadsheets and paper-based processes – became increasingly inefficient and error-prone. This not only led to delays but also increased the risk of compliance violations.
Problem
The company, which had Jira Cloud and Confluence Cloud already in use, recognized that it needed an additional and comprehensive digital solution to meet the complex regulatory requirements without slowing down the innovation pace of its development processes. The company sought an approach that was both agile and scalable, while also ensuring necessary compliance.
Solution on Atlassian Cloud
By partnering with Eficode and SoftComply, the company was able to implement a robust and agile risk and document management solution, fully integrated into their existing Jira and Confluence platform. This approach enabled the company to centrally manage their risks and documentation, while remaining flexible to adapt to changes in regulatory requirements.
- SoftComply Risk Manager Plus: With the introduction of the SoftComply Risk Manager Plus app in Jira Cloud, a centralized location was created where risks could be systematically identified, assessed, and tracked. Each risk was linked to a specific process or product development project, ensuring full traceability.
- SoftComply Document Manager: The documentation requirements under ISO 13485 and FDA 21 CFR demanded precise management and versioning of documents. The integration of Confluence allowed the company to store compliance-related documents in a centralized and structured manner. With version control and audit trail functionality, documents could be updated and tracked at any time.
- Custom Jira Workflows by Eficode: Eficode developed custom workflows in Jira to automate the compliance processes and seamlessly integrate with the SoftComply tools. Manual and time-consuming tasks, such as generating risk and audit reports, were automated, leading to significant efficiency gains.
Results Achieved
- Accelerated Audit Preparation: Centralized storage and management of compliance documentation in Confluence reduced audit times by 30%. Company was prepared for the audit with continuously managed documents organised as needed.
- Increased Product Safety: By integrating safety and security risk management into development processes in Jira, product safety was ensured early on and by automating the risk management process the possibility of human error was reduced considerably. Automatically generated audit trail and risk traceability significantly reduced the time to prepare for the audit. Each risk now has an owner who gets automated notifications for risk reviews.
- Agility Despite Stringent Regulations: Thanks to the flexible, agile solutions, compliance processes could be quickly adapted to new regulatory requirements. This enabled the company to respond more rapidly to market changes while maintaining the highest standard of compliance.
Conclusion
Would you like to learn more about SoftComply’s apps for risk management and document management for MedTech companies in the cloud? Book an intro call here to discover more.
