Planisware’s Post

ℹ️ 𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝗿𝗶𝘀𝗸 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁–𝗔 𝗻𝗲𝘃𝗲𝗿-𝗲𝗻𝗱𝗶𝗻𝗴 𝗽𝗿𝗼𝗰𝗲𝘀𝘀 Software #RiskManagement is a continuous and iterative process that takes place throughout the product’s lifecycle. The infographic below illustrates the connection between typical system development activities and potential hazardous situations and risk control measures. 🔏 𝗧𝗶𝗽! 𝗚𝗼𝗼𝗱 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝗽𝗿𝗮𝗰𝘁𝗶𝗰𝗲 𝗶𝘀 𝘁𝗼 𝘀𝘁𝗮𝗿𝘁 𝗮𝘀 𝗲𝗮𝗿𝗹𝘆 𝗮𝘀 𝗽𝗼𝘀𝘀𝗶𝗯𝗹𝗲 since late discoveries can impact both your software safety classification and the complexity of your design. Learn systematic and practical knowledge about #software for #MedicalDevices and #IEC62304 from our software expert Christian Kaestner: https://lnkd.in/dEgrrKqB

Super nice development of the Kiwa Comply SaaS tool so far and even nicer developments on the way! Patrick Coomans really gives me way too much credit, compliments to Jyrki Lahnalahti and Laura Lindholm as founder of this very easy to use tool and willingness to work together for further developments. Also a thank you to Christiaan Woldendorp (Msc) for sharing his expertise on the #NIS2. I would like to note that ISO 27001 is an important standard and the #CyFyn can also help tremendously in the route to #NIS2 compliance. But don't forget that the #IEC62443 standards, among others, can also play an important role in the route to compliance. Would you like to stay informed about the route to compliance under the #NIS2 the #CRA or maybe even the #RED? Or perhaps you are interested about news and updates around #ISO27001, #IEC62443, #ETSI303645 or the #EN18031 standard, please sign up for Kiwa Cybersecurity.

Finding the right document in seconds is a game changer. qmsWrapper’s intelligent filtering and search functions help you locate any file instantly. Stay focused on what matters – compliance and quality. #QMS #DocumentControl

Believe it or not, there’s a more effective way to track and manage your compliance than using spreadsheets. And no, it’s not ignoring it all together. Compliancy Group’s software helps to automate everyday processes that have your head spinning. 🧑⚕️ Need to assign training? Our training module allows you to select certain employees/locations/groups that need to take training. ✏️ Need a new policy? Check out our library full of templated policies ready for you to use. 🤝 Need an Incident Response Program? Lucky for you we have a quick start guide that outlines everything you need. We'd write out the rest but let’s be real, this post would take up your entire feed. Learn what else we have to offer: https://bit.ly/3zl1yiz

🆕 Beaking news !🆕 We have just released our Auditing application today ! This application, entirely developped with the #powerplatform from Microsoft, covers the following area in its first version: - Hazard log/compliance - Mitigation/compliance plan - Audit checklists - Audit - Root Cause Analysis - Corrective Action plans It will now be tested internally and eventually integrated to our Audit Management application which covers auditor management and planning aspects of your #safety and #quality audit programs. We will keep you posted on the back of our first tests ! #QMS #SMS #AuditProgram Daniel Stocky Joanne Stocky Now I See Consulting #Dataverse

Is your team ready for the upcoming CMS audit season? Inovaare’s Program Audit Readiness Self-Assessment Tool will help you gain insights on critical audit areas and expose gaps so you can plan effectively for a Program and Focus Audit. https://bit.ly/48rny6Y Get started today! #CMSProgramAudit #selfassessment

More information on the new part of the standard for requirements for usage information for complex systems. The new part of the standard has been initiated in the ISO IEC 82079-x series.   Arguments in favor of the new standards section: ·       IEC/IEEE 82079-1, "Preparation of instructions for use of products - Part 1: Principles and general requirements" contains principles and general requirements for instructions for use. ·       IEC/IEEE 82079-1 already contains general specifications for instructions for use for complex systems in various sections. ·       The need for specific requirements for user information for complex systems goes beyond these general requirements. ·       The specific requirements for information for use in complex systems are developed in the standard as part of the ISO IEC 82079 series. The requirements of Part 1 are specifically supplemented. ·       The need for this new standard was recognized over 20 years ago. The work on the new standard will start shortly at international level.   Candidate questions to be answered by the new standard are ·       how can safety-related information on interfaces be designed? ·       what are the requirements for appropriate risk management? ·       how should the different terminology of the individual supplier documents be dealt with? ·       what should be done if the supplier information is not available in the required languages? ·       is a "main document" required for a complex system (see IEC 62023)? ·       how is reference made to which content from supplied information products in the main document, or how is information from them integrated? ·       how can project management / handover management be set up if the delivery of content extends over months or years? ·       how can information for the use of the numerous components and subsystems of complex systems in the various life cycle phases be made available in a user-friendly way? ·       how can the various media be linked together? What are the requirements for a suitable content delivery portal? ·       what specifications must be made for information models so that heterogeneous supplier usage information fits together and can be communicated in a comprehensible manner? ·       how can the digital type plate regulated in IEC 61406 Identification Link be interlinked with the unique usage information of the product in complex systems? ·       how can responsibility and compliance management be implemented in such complex information management processes? And many more questions.

Congratulations to tiller, who got their ISO 27001 certification in just 6 weeks through our Digital Trust Accelerator program! 🎉 Tiller provides conversation guidance software designed for sales and customer success teams, offering real-time prompts during video calls to help guide discussions, suggest questions, and identify pain points based on the conversation's flow. They pursued their ISO 27001 certification to meet strict information security requirements, enabling them to confidently approach accounting firms with their automated financial auditing software. By leveraging our Digital Trust Accelerator—combining our collaborative expert sessions, Vanta’s automated compliance platform (automating up to 80% of the policy work), and Insight Assurance’s seamless auditing—Tiller achieved their ISO 27001 certification in just 6 weeks! 🥳 Kudos to Alastair, Duncan, and the entire Tiller team for their dedication! 💪 #ISO27001 #Framework #GRC #Compliance

Simplify your Subject Access Request process! Our course offers practical tips and strategies to manage Subject Access Requests efficiently. Say hello to hassle-free compliance.

The primary purpose of a Document Management System (DMS) is to streamline document-heavy processes, improve efficiency and ensure easy access to information across the organization. Though a major issue with a typical DMS is that they are developed for documents and not users. How can we overcome these challenges with a few simple alterations without compromising on structure and security? Read our thoughts about this subject in our latest blog post: https://lnkd.in/dADDTauU #documentmanagement #dms #cms #bpm #borgent #blog