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Marion Lepmets
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...
Marion Lepmets
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...
Marion Lepmets
On February 1, 2024 SoftComply held a webinar on Data Privacy and Security where Ocumetra shared their experience on preparing for and attaining the ISO 27001 certificate. Following is a summary of questions asked and answers provided – full case study can be viewed also in the YouTube video. Ocumetra...
Marion Lepmets
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...
Marion Lepmets
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...
Marion Lepmets
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...
