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 […]
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 […]
The Document Management Solution You Have Been Waiting For: THE SOFTCOMPLY DOCUMENT MANAGER
TL;DR INTRODUCTION Choosing the appropriate document management system for your company is a critical task. You will commit the company and employees to a specific software tools for years to come. The choice of the correct platform depends on many factors, such as user requirements, size of the company and requirements for compliance (e.g. 21 […]
HOW TO USE THE AUTOMATION ASSISTANT OF THE RISK MANAGER PLUS?
We have just released a new Automation Assistant for the SoftComply Risk Manager Plus app – a feature some of you have requested. We heard you and we have now delivered it 😉 With the Automation Assistant you can automatically set values to your risks without having to set them manually in the Risk Manager […]
