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 […]
Why Should Validation Work Silently in the Background?
Validation of software tools often leads to significant confusion as regulations mandate it but companies are often still unclear how to approach it. Validation is a regulatory requirement for safety-critical industries e.g. MedTech, aerospace, automotive. What is Validation? In essence, validation is the critical process of assessing a software tool to ensure it aligns with […]
AI in Medical Devices
The availability of AI on the web has not materialized like the murderous SkyNet from the Terminator Series or HAL9000 from 2001: A Space Odyssey. Instead, it is a consumer tool to generate funny pictures or get school assignments done with no effort. AI tools have, in fact, been around for a while – used […]
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? […]
Empower your Team Without Being a Constant Snag
The exact quote from our customer that inspired this heading was: “There’s a delicate balance between holding team members accountable and coming across like a jerk.” This speaks volumes of the additional complexity that comes with Risk Management. You would think that the complexity lies within putting the correct method, the models, the way we […]
