Information Security (ISO 27001) Risk Management Best Practices for 2025
Keeping your data safe is vital for every business. One way to do this is by following ISO 27001. But how can we manage these information security risks with a tool like Jira? Let’s dive in! What is Information Security Risk Management Information Security Risk Management is all about identifying, assessing, and managing risks to […]
NIS2 and DORA Compliance and Protecting your Atlassian Cloud Data
This is a guest-article from Atlassian Marketplace Partner, Revyz In late 2022, the European Parliament introduced the Network and Information Systems Directive (NIS2) and the Digital Operational Resilience Act (DORA) to enhance cybersecurity across the EU. NIS2 requires compliance by EU member states by October 18th, 2024, focusing on robust security measures for digital service […]
Supporting Regulated Industries on Atlassian
On May 2, 2024 SoftComply hosted the 2nd edition of Regulated Industries workshop during Atlassian Team event. The workshop’s title was “How to best support Regulated Industries on Atlassian” and was aimed to discuss the customer feedback and best practices of collaboration between Atlassian, app vendors and solution partners to support our customers. For 2 […]
What are the FDA 21 CFR 11 Compliant Electronic Records?
Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11, deals with the requirements for Electronic Records and Electronic Signatures to be considered “trustworthy” by the FDA. If you work in the MedTech or Pharma sector, you probably have heard about this regulation plenty of times. And if you […]
What is an FDA 21 CFR 11 Compliant Electronic Signature?
Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11, deals with the requirements for Electronic Records and Electronic Signatures to be considered “trustworthy” by the FDA. If you work in the MedTech or Pharma sector, you probably have heard about this regulation plenty of times. And if you […]
3 Best Jira Cloud Risk Management Plugins Compared [2024]
Comparison of risk apps on Jira Cloud
Demystifying Software Tool Validation
Ever wondered why software tool validation is crucial in the medical device industry? With modern medical regulations putting more emphasis on the management of software tools, it’s become an important part of the puzzle. Companies use various applications in the lifecycle of a device, and they must ensure they work as expected, based on how […]
Don’t Leave Your Quality Team Behind!
Your Development team might find the instructions from Quality and Compliance team time-consuming – slowing down their delivery time, but the regulatory standards are put in place to ensure the safety, effectiveness and integrity of products from different industries. There are significant consequences for non-compliance ranging from loss of business and legal penalties to your products being […]
End App Fatigue with one Risk Management Solution
For decades organisations have been struggling with working in silos with different departments working with several stand-alone software tools, each for a specific task. With tools like Jira and Confluence that cater to a variety of different needs you can set up your entire organisation on one platform. So, there should be no more complaints? […]
Turning Confluence Cloud into a Compliant Document Management System
SoftComply Document Manager is the newest Confluence Cloud app for managing documents with dedicated Workflows and e-Signatures. With this app you will turn your Confluence Cloud into a compliant document management system with: Book a Dedicated Live Demo call to check out the full functionality of the SoftComply Document Manager! Following is a simple 5-steps […]
