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 […]
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 […]
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 […]
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 […]
Validation of Confluence Cloud
What to validate in your Confluence cloud instance and how to do it
Software Tool Validation in the Medical Device Industry – A White Paper
WHITE PAPER ON REGULATORY REQUIREMENTS AND BEST PRACTICES FOR VALIDATION For More News on Validation:
Agile eQMS to Move Faster & Break Nothing
Our customer Orthogonal describes how to set up an agile eQMS solution on Atlassian Confluence and Jira
