Marion Lepmets _SoftComply_ Community Champion

Project risk management is crucial for project success, and especially important to keep critical risks under check in case of (inevitable) changes. The hidden complexities of a project is the main reason why timelines are not met and the resources are spent mid-way. Below is a quick guide to a Project Manager how to best…

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 are an…

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 are an…

🙌 As Atlassians from across the world are making their way to Las Vegas for the Atlassian event of the year - Team '24, we would like to invite you to a Breakfast Workshop on May 2 at 9am PST in the Venetian. 🥞 🎙️ After you grab your coffee and breakfast, you will be treated to a fantastic set of talks & can join the…

Your medical device 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…

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…

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…

What is Hazard Analysis? Hazard Analysis is described as the Risk Management process in ISO 14971. It is a Top-Down type of risk analysis, starting from the end effects - Hazards and Hazardous Situations, and then proceeds backwards to identify the “reasonably foreseeable sequences or combinations of events that can result…

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…

🤔 𝑯𝒐𝒘 𝒕𝒐 𝒎𝒂𝒏𝒂𝒈𝒆 𝒄𝒐𝒏𝒕𝒓𝒐𝒍𝒍𝒆𝒅 𝒅𝒐𝒄𝒖𝒎𝒆𝒏𝒕𝒔 𝒊𝒏 𝑪𝒐𝒏𝒇𝒍𝒖𝒆𝒏𝒄𝒆 𝑪𝒍𝒐𝒖𝒅? 📣 Join us this Thursday to learn all about it! 🗓 Feb 29th 🕓 4pm CET / 10am EST 👉 👉 Register Here: https://us02web.zoom.us/webinar/register/WN_RyMfIWYuQ92zqJhnKaRNVQ 👈👈

“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) Image: Warner Bros. The same applies in business in general - no company operates without risks. For you to have started a business, you have…

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 list to their next…

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…

On February 1, 2024 SoftComply held a webinar on Data Privacy and Security where Ocumetra shared their experience of 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 is an Irish company…

🤔 𝐖𝐡𝐚𝐭 𝐚𝐫𝐞 𝐭𝐡𝐞 𝐛𝐞𝐧𝐞𝐟𝐢𝐭𝐬 𝐨𝐟 𝐡𝐚𝐯𝐢𝐧𝐠 𝐲𝐨𝐮𝐫 𝐑𝐢𝐬𝐤 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐢𝐧 𝐉𝐢𝐫𝐚? 🔔 Join us tomorrow, 𝐅𝐞𝐛𝐫𝐮𝐚𝐫𝐲 𝟕 at 𝟑𝐩𝐦 𝐂𝐄𝐓, to hear and see all about it --> SoftComply Risk Manager Plus on Jira Cloud. 👉𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐡𝐞𝐫𝐞👈

🧐 Join SoftComply to learn how to get Quality and Document Management audit-ready for the Regulated Industries on Confluence Cloud! ✍️ Register here ✍️

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…

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…

🚀 Join SoftComply for a Live Webinar on How to Manage All Organisation's Risks in Jira 🚀 🗓️ November 29th 🗓️ 🕒 3pm CET / 9am EST 🕒 REGISTER HERE

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…

🚀 Join our 45min Live Demo of the SoftComply Document Manager ✍️ REGISTER HERE ✍️

🚀 Join us this Wednesday for a Webinar & Live Demo of Risk Management 🚀 🗓️ Wednesday, November 8 🕒 3pm CET / 10am EST ✍️REGISTER HERE✍️