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
Software Risk Analysis in Medical Devices
In the Medical Device industry software components, whether standalone or as part of a physical device, must follow the same rules as any other component, i.e. ISO 14971 “Medical devices – Application of risk management to medical devices”. BUT .. but there are significant deviations required by IEC 62304 and the GDA guidance document “Content […]
Risk Management of Off-The-Shelf (OTS) Software
Your software is likely to contain a number of components, items, packages, libraries, etc. not developed directly by your company. It may include open-source or purchased software. Unless you have a very close relationship with the developer and access to the source code, these components are black boxes for you. According to IEC 62304, the […]
Hazard Analysis and FMEA: the Most Common Approaches to Risk Management for Medical Devices
What is the difference between Hazard Analysis and FMEA. Which approach should you use. Comparison and examples.
4 Key Reasons Why you should move your Risk Management to Jira
Risk management in the regulated industries is often viewed as a necessary evil, but what if we approached it as a secret weapon instead? It’s a common misconception that risk management slows down innovation and adds unnecessary layers of bureaucracy. Yet, in reality, effective risk management is the linchpin of sustainable growth and resilience, especially […]
4 Steps to ISO 27001 Compliance – Start with Risk Management in Jira
Being an ISO 27001-compliant company means that you protect your information assets and client data against possible data breaches. It supports your business growth as it builds trust in your company and your products. In the hopes of achieving ISO 27001 compliance quickly, many companies purchase a huge ISO 27001 requirements checklist and templates for […]
3 Simple Steps to Prioritising your Critical Risks
“It’s a dangerous business, Frodo, going out your door. You step onto the road, and if you don’t keep your feet, there’s no knowing where you might be swept off to.” (B. Baggins) The same applies in business in general – no company operates without risks. For you to have started a business, you have […]
Risks? We don’t have any… 6 Steps to Identify Organisational Risks
More often than not, Risk Managers confess to us that when they ask their colleagues about the critical risks in their department, the answer is: “We have no risks!” This is a problem, since it highlights that the concept – what is a risk – is unclear. We recommend Risk Managers to take an actionable […]
Managing Documents in the 21st Century
INTRODUCTION Although paper records still have their place in the modern industry, most companies use one or more software applications to manage documentation. Choosing the appropriate electronic document management system (eDMS) for your company is a critical task. You will commit the company and employees to a specific software tools for years to come. The […]
