Don't miss our LinkedIn Live session next week with Sware's Bryan Ennis as he unpacks "GxP Compliant AI: A Strategic Guide to Modernize Quality Management." As life sciences organizations increasingly adopt AI technologies, ensuring GxP compliance becomes more complex. Learn how to navigate this changing landscape while reducing validation debt and maintaining regulatory alignment. Register now to secure your spot and discover strategies for building a GxP-compliant foundation for AI implementation. https://lnkd.in/eQd99q-4 #GxPCompliance #AI #QualityManagement #LifeSciences #ValidationStrategy #LinkedInLive #RegulatoryCompliance
Sware
软件开发
Chelsea,Massachusetts 3,142 位关注者
Leading digital validation and process automation across the healthcare, life sciences, and medical device industries.
关于我们
Sware's mission is to rescue organizations of all sizes — from startups to multinational enterprises — from the grip of validation debt; the unpaid cost of release, testing, GxP, and business requirements. The Res_Q? software platform offers life sciences companies and CDMOs a leading-edge, data-first validation solution, helping organizations eliminate validation debt and ensure peace of mind in an increasingly complex technology ecosystem. Sware was founded by a team of experts who have been at the forefront of life sciences software for nearly 20 years. We have helped many companies transform how they research, manufacture, and monitor the safety of their therapies. As the leader in paperless validation process automation, we help organizations reduce validation time by up to 75% while increasing transparency, ensuring traceability, and maintaining the highest standards of compliance. Our unified platform consolidates validation across enterprise systems, streamlines workflows through intelligent automation, and provides unprecedented visibility into validation status and KPIs. Visit www.sware.com to learn more.
- 网站
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https://www.sware.com/
Sware的外部链接
- 所属行业
- 软件开发
- 规模
- 51-200 人
- 总部
- Chelsea,Massachusetts
- 类型
- 私人持股
- 创立
- 2015
- 领域
- Validation、Test Execution、SOP、Quality Systems、SaaS、NetSuite、Veeva、GxP、21 CFR Part 11、Automated Testing、Compliance、FDA、Computer Software Assurance和Release Management
产品
Res_Q
自动化测试软件
At Sware, our mission is to rescue life sciences companies from the grip of validation debt; the unpaid cost of release, testing, GxP, and business requirements. Our Res_Q? platform offers the most complete validation solution available today. Res_Q eliminates validation debt and ensures peace of mind in an increasingly complex technology ecosystem.
地点
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主要
214 Arlington St
US,Massachusetts,Chelsea,02150
Sware员工
动态
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In our latest video, Sware's Chief Quality Officer Bryan Ennis breaks down: - The different types of AI impacting life sciences - Key considerations for implementing AI in regulated processes - How to approach AI validation strategically from a Quality perspective Watch now to understand the fundamentals of AI in regulated life sciences and prepare your organization for this technological shift. #AIinLifeSciences #GxP #QualityManagement #RegulatoryCompliance #Biotechnology
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"The difference pre- and post-Res_Q is simply night and day." When validation needs threatened to overwhelm this growing pharma research company, they took action. The results? - Accelerated validation by 75% - Eliminated validation debt completely - Freed up FTE hours for strategic work - Reduced validation packages from 15 to under 10 - Automated end-to-end validation workflows From weeks to days—see how they transformed their validation approach while scaling operations. Read the full case study here. https://lnkd.in/eTjkxEJE #Pharma #ValidationTransformation #LifeSciences #QualityExcellence #Innovation
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Manual validation processes aren't just inefficient—they're unsustainable in today's rapid-release environment. Forward-thinking organizations are discovering that automation delivers more than just efficiency. Automation also delivers: - Reduced validation cycle times - Enhanced traceability and compliance - Eliminated manual errors and rework - Improved resource utilization - Real-time visibility across operations Read our latest blog to learn how automated, paperless validation is transforming life sciences operations. https://lnkd.in/e-MzDwky #LifeSciences #Validation #DigitalTransformation #QualityManagement #Automation
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?? LIVE EVENT: Join us for an insightful LinkedIn Live session with Bryan Ennis, Chief Quality Officer and Co-Founder of Sware! ?? March 26, 2025 | ? 11 AM EST GxP Compliant AI - Modernizing Quality Management The life sciences landscape is evolving rapidly. As organizations adopt AI and machine learning technologies, traditional validation approaches are creating bottlenecks rather than enabling innovation. Bryan Ennis will share his expertise on: - Implementing data-first strategies that prepare you for AI adoption - Transitioning from CSV to CSA methodologies - Reducing validation time by up to 80% while maintaining compliance - Creating collaboration between IT and Quality teams Register now: https://lnkd.in/eQd99q-4 #biotechnology #lifesciences #computersystemvalidation #AIhealthcare #quality
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As AI revolutionizes life sciences operations, understanding its impact on GxP regulations is crucial. Whether you're in R&D, manufacturing, or quality control, staying informed is key. Explore our curated resource library covering: - Clinical Development AI - Manufacturing Intelligence - Quality Management - Regulatory Compliance - Data Governance Download or review our resources focused on AI in regulated environments and stay ahead of the curve. https://lnkd.in/ejEpvAb4 #biotechnology #lifesciences #computersystemvalidation #AIhealthcare #quality
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The challenge: deliver a validated solution without redirecting valuable internal resources or rebuilding core platform functionality. See how one leading software solutions provider: - Achieved seamless GxP validation integration - Maintained development velocity - Met customer compliance requirements - Protected core engineering resources - Accelerated market entry Ready to transform your approach to GxP validation? Request a demo to learn how we can help you achieve similar results. https://lnkd.in/g77787vm #SoftwareValidation #GxP #ProductDevelopment #Innovation #Compliance
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Building solutions in GxP spaces shouldn't mean choosing between innovation and compliance. Yet many software providers find themselves at this crossroads. GxPNext helps you: - Simplify validation integration into your product - Accelerate time-to-market in regulated industries - Execute compliance requirements without rebuilding - Scale confidently in GxP environments Stop letting validation slow your growth. Learn how GxPNext can help you build compliance-ready solutions without compromising innovation. https://lnkd.in/eN7NA2n9 #SoftwareDevelopment #GxP #Validation #Innovation #LifeSciences #TechInnovation
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As AI capabilities expand into regulated operations, Quality Teams face a critical question: how do we maintain control while enabling innovation? Watch our expert panel explore: - Practical approaches to AI validation in GxP environments - Quality system considerations for AI implementation - Best practices for IT and Quality collaboration - Real-world examples of controlled AI adoption Don't miss an essential discussion on building a foundation for AI success in regulated environments. Click the link now to watch our webinar: "Building Quality into GxP AI." https://lnkd.in/eFPGyins #ArtificialIntelligence #QualityManagement #GxP #LifeSciences #Compliance #Innovation
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When validation processes don't scale with your business, something has to give. See how two leading CDMOs transformed their operations: Company A: - Unified validation across 9 global manufacturing sites - Successfully validated 3 critical SaaS systems - Enabled strategic reallocation of quality resources Company B: - Achieved 1.5 FTE annual savings on ERP validation - Eliminated 5+ release validation backlog - Created single source of truth for documentation "The [Sware] team really understands the unique challenges CDMOs face. What impressed me most was their ability to provide both a sleek, modern validation tool and skilled resources who deliver results quickly." Ready to write your own success story? Request a demo of Res_Q, the leading-edge GxP validation platform, today. https://lnkd.in/g77787vm #CDMO #ValidationTransformation #QualityExcellence #LifeSciences #Manufacturing
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