Yesterday, Verena Wieser successfully presented on the topic "Requirements Management: Building a Robust Framework for Secure Software" at MedConf 2024.🎉 Below are some valuable insights from the presentation: 📌A good requirements management is the base for the development of safe and secure medical device software. Many problems that occur with medical device software are the results of unclear and faulty requirements that led to misunderstandings by the involved stakeholders. ❌ 📌The EARS methodology provides a set of key words and simple rooms to depict requirements in a simple and understandable way in English language. 📌A term that is strongly related to requirements management is traceability. Its aim is to provide evidence from the initial idea to the delivered software. This includes traceability between system requirements, software requirement, risks, risk control measures, verification, and validation activities. 🔗 📌The obvious way to document this traceability is to create a trace matrix but this can get an exhaustive and error-prone activity. 📌It is more efficient to use the various tools that are available on the market to support requirement management. The choice of the right tool depends on the team and the established processes. Each tool has its advantages and disadvantages that need to be considered in software tool validation as required by ISO 13485 before productive use. 🛠️ 👉 For more insights, contact us for consultancy: info@lorit-consultancy.com 📧 #MedConf2024 #RequirementsManagement #ISO13485 #LoritConsultancy
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│CASE STUDY│Thank you, Andreas Antoniou, for sharing Biomni's experience with Conformio. Check out this case study to learn how Biomni ensured ISO 27001 certification on deadline and within a set budget using our compliance software. #Conformio #ISO27001 #compliance
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In our latest blog post, we delved into the principles of validation, exploring the Computerized Systems Lifecycle and the collaborative dynamics between suppliers and regulated companies. The structured quality system of suppliers serves as a guiding force in this symphony, while users play a crucial role as the regulatory bridge. The discussion extends to the realm of third-party validation, presenting a neutral perspective aimed at streamlining the validation process. FIVE Validation, our company, helps with meticulous documentation, ensuring impartiality throughout. Discover how a Validation Lifecycle Management System, such as GO!FIVE® Software, coupled with expert assistance, can not only simplify but also enhance your validation journey. Our database and templates, enriched with over 15 years of experience, provide a resourceful means to save both time and costs. Read more: https://lnkd.in/d2dxRNPV #ValidationPrinciples #Collaboration #ThirdPartyValidation #GOFiveSoftware #ExpertAssistance
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In our latest blog post, we delved into the principles of validation, exploring the Computerized Systems Lifecycle and the collaborative dynamics between suppliers and regulated companies. The structured quality system of suppliers serves as a guiding force in this symphony, while users play a crucial role as the regulatory bridge. The discussion extends to the realm of third-party validation, presenting a neutral perspective aimed at streamlining the validation process. FIVE Validation, our company, helps with meticulous documentation, ensuring impartiality throughout. Discover how a Validation Lifecycle Management System, such as GO!FIVE® Software, coupled with expert assistance, can not only simplify but also enhance your validation journey. Our database and templates, enriched with over 15 years of experience, provide a resourceful means to save both time and costs. Read more: https://lnkd.in/d2dxRNPV #ValidationPrinciples #Collaboration #ThirdPartyValidation #GOFiveSoftware #ExpertAssistance
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Once again, the GENEO Software team has flown through its ISO 9001 accreditation, this time with only one NCR. In the three years we have held accreditation, we have only received 5 NCRs. Certificate: FS 688736 We have achieved this only by using our very own GEN-OPS software, which has proven essential for simplifying the process of achieving compliance. The assessors reviewing our QMS are always complimentary about how effectively GEN-OPS aligns our processes. While striving for ISO 9001, organisations often encounter the same obstacles that impact the effectiveness of their QMS. Our GEN-OPS software mitigates many of these common problems by enhancing engagement across the entire workforce and by encouraging sharing while driving compliance and improvement. This is why GEN-OPS helps to overcome the common difficulties associated with achieving ISO accreditation, namely: - Lack of top management commitment - Insufficient employee involvement - Incomplete documentation - Non-alignment with business processes - Overcomplicating the system - Lack of continuous improvement - Limited internal communication - Underestimating the time and effort required #ISO9001Software #QualityManagementSoftware #QMSsoftware #ISOCompliance #ISOTools #QualityAssuranceSoftware #ISO9001Solution #AuditSoftware #processautomation #ISOImplementation #QualityControlSoftware #ISO9001Technology #compliancemanagement #ISO9001Systems #qualitysoftware #documentcontroller #documentcontrol #ISO9001Consultancy #RiskManagementSoftware #ISO9001Audits #ISO9001Reporting #iso9001 #iso90012015 #iso9001certified #iso9001certification #qms
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With manual, paper-based quality systems, preparing for your annual management review can be a time-consuming nightmare. But there's a better way: with Qualio. Download our user guide to learn how to apply our eQMS software and make management reviews quick, easy and painless 📖 #managementreviews #qualitymanagement https://bit.ly/49sCSlV
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Navigating software validation can be a challenge, especially for regulated companies with limited resources. To streamline the process, consider these expert tips from MasterControl. ⬇️ #MedTech #MedicalDevices #RegulatoryAffairs #SoftwareValidation
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Account Executive at Compliance Group Inc. | Specializing in Pharmaceutical, Medical Device, and Biotechnology Industry Solutions | Driving Compliance Success
Compliance Group Inc experts are driving key industry trends! Please join us for our first FREE webinar of 2024 "Enabling Advanced Manufacturing with Digital CSA," and break free! Mark your calendars for February 20, 2024! Our panel of experts will dissect how Digital #CSA is the game-changer revolutionizing time-to-market, efficiency, and compliance in FDA-regulated environments. Demystify Industry 4.0: Understand the key concepts driving this transformative movement. Unlock CSA's potential: Discover how risk-based CSA streamlines software control, boosts efficiency, and accelerates innovation. Learn from Flex: Hear their firsthand experience implementing Digital CSA and witness the tangible benefits they've achieved. Interactive Q&A: Get your industry 4.0 CSA and CSV questions answered by our expert panel and gain personalized insights. Actionable takeaways: Walk away with a clear roadmap to implement Digital CSA within your own organization and unlock the full potential of Industry 4.0. 🎙 Speakers: 🎤 Khaled Moussally-EVP Quality – Clients & Regulatory Relations, Compliance Group Inc. 🎤 Garth Conrad-Vice President, Quality at Flex Health Solutions Date: February 20, 2024 ,10:00 AM(EST) Don't miss this pivotal opportunity to: Supercharge your product development cycles. Gain the competitive edge in the Industry 4.0 race. Navigate FDA compliance with confidence. Future-proof your operations for continued success. Register Now: https://lnkd.in/gCYkfKWR #fda #csa #manufacturing #digitalization #advancedmanufacturing #industry4point0 #quality #regulatorycompliance #regulatoryrelations #qualityassurance #flex #complianceg #qualitycompliance
Securing Industry 4.0:Navigating the Digital CSA Landscape
https://www.complianceg.com
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Just released OpenQMS.NET 1.0! Sign documents digitally, manage trainings, track deviations, changes and CAPA on products, processes, plant assets and more. #qualitymanagement #qualitysystem #qualityassurance
Open Source and Free Quality Management System | OpenQMS.net
c-realize.com
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Upcoming #webinar | *Can ISO 27001 implementation be automated using Conformio?* I’ll discuss if compliance software can bring value to ISO 27001 project - register here: https://lnkd.in/gUsbhG-Q #ISO27001 #ComplianceAutomation
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