GO!FIVE? is a digital validation software designed for Life Science companies to manage the entire lifecycle. It simplifies processes and audit preparations. #validationsoftware #software #paperlessvalidation #pharmaceuticalindustry #lifescience #digitalvalidation
FIVE Validation
软件开发
Sorocaba,S?o Paulo 8,967 位关注者
Digital and agile framework with templates for AI and traditional technologies
关于我们
Life Sciences companies including pharmaceutical and medical devices are required by regulatory agencies such as the FDA, EMA, and WHO to validate and qualify their systems, processes, and equipment. This activity is time-consuming, bureaucratic, and done on paper. Validation is an activity that if not done successfully can impact the business by preventing it from operating. To solve this problem, FIVE developed a cloud tool that contains information (content) that allows the user to work 6x faster, in addition to protecting the environment by not using paper. FIVE's software product: - GO!FIVE paperless validation solution. FIVE provides the following professional services: - Computer System Validation - Equipment validation - Utilities qualification - IT and OT infrastructure qualification - Data integrity projects - Training and consulting
- 网站
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https://www.fivevalidation.com
FIVE Validation的外部链接
- 所属行业
- 软件开发
- 规模
- 11-50 人
- 总部
- Sorocaba,S?o Paulo
- 类型
- 私人持股
- 创立
- 2008
- 领域
- System Validation (CSV)、Production Equipment Qualification (CQV)、Utilities Qualification、IT and OT Infrastructure Qualification、AI Validation、Training、e-validation、Data Integrity、Valida??o de Sistemas (VSC)、Qualifica??o de Equipamentos de Produ??o、Qualifica??o de Utilidades、Qualifica??o de Infraestrutura de TI e TA、Valida??o IA、Treinamento、Gerenciador de Ciclo de Valida??o、Integridade de Dados、Agile Validation、Digital Validation、Qualifica??o de Infraestrutura de TI e OT、Valida??o Digital、VLMS和Valida??o Digital
地点
FIVE Validation员工
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Laura Matsumura
COORDENADORA | FIVE Validation - CSV / COMPLIANCE / QUALIFICA??O / GEST?O
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Silvia Martins
CEO and Co-Founder, Validation of AI and traditional technologies for Life Science companies | Digital and agile methods, from idea to patient | ISPE…
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Bruna Barros
Valida??o | Medical Copywriter | Informa??es Médicas
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Diego Galv?o
Fullstack Developer | React.js | Next.js | Typescript | Node.js
动态
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Data Security Matters ?? In the realm of technology, particularly for Life Science companies, firewalls are only the first line of defense. Robust IT infrastructure—including hardware, software, and cloud services—plays a critical role in safeguarding sensitive data. Ensuring product and patient safety must remain central to the supplier selection process, with stringent security controls and measures in place. For insights into IT and OT qualification for both AI-driven and traditional technologies, visit: https://lnkd.in/eRw_hAnT #CyberSecurity #LifeSciences #DataProtection #ITInfrastructure #CloudSecurity #AI #OT
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Yesterday, Silvia Martins, Co-Founder and CEO at FIVE Validation pitched Empowering Life Sciences with Validation tool and services for GxP AI and traditional technologies in digital and agile methods at the Life Science Café event at the Leiden Bio Science Park. GO!FIVE, a cloud tool that accelerates validation by 6x, reducing paper use and meeting regulatory standards. Thank you to the organizers, attendees, and everyone who made this an excellent opportunity to network with Life Science professionals. Special thanks to Chris Jaeger, Dani?l Bruning, Yaella Essed and Salomi Smyri. #lifescience #aivalidation #digitalvalidation #software #validationsoftware #pharmaceuticalindustry #paperlessvalidation #LifeSciences
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Why Data Governance in AI is Crucial for Life Sciences? In the world of Life Sciences, where patient safety and data integrity are top priorities, AI Data Governance plays a vital role. It’s more than managing data—it’s about safeguarding lives, ensuring compliance, and building trust in every product and process. The biopharma, medtech, and biotech industries operate in complex, high-stakes environments, making robust data governance a must. From categorizing and mapping data to defining who has access and when it’s shared, a strong governance framework answers essential questions and mitigates risks. Curious about how this framework can benefit your organization? Discover more in our latest article:
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The integration of Artificial Intelligence (AI) into the Life Sciences industry brings innovative potential, from drug discovery to personalized medicine. However, incorporating AI into GxP (Good Practice) environments, which are governed by regulations to ensure product safety and efficacy, introduces additional challenges in AI validation. AI validation levels define the control measures needed for regulatory compliance. Check our article for more details about what should be addressed, key principles, steps to validate AI, and more. #AIValidation #ArtificialIntelligence #GxPCompliance #LifeSciences #PharmaceuticalIndustry #MedicalDevices #RegulatoryStandards #FDACompliance #EMAGuidelines #ControlSystems #AIRegulation #AICompliance #ValidationProcess
Validating Artificial Intelligence in GxP Environments: A Guide for Life Sciences
Silvia Martins,发布于领英
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Do you know the importance of AI validation in GxP environments? With over 16 years of experience in validation services for Life Science industries, FIVE Validation developed GO!FIVE?—a digital validation software with templates for AI and traditional technologies, built on agile methodology and trusted by over 90 clients. For assistance with your AI validation system, feel free to reach out to us at [email protected] #validationsoftware?#software?#paperlessvalidation?#pharmaceuticalindustry?#lifescience?#digitalvalidation #aivalidation
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The second day of the MEDICA 2024 exhibition in Düsseldorf is buzzing with activity at the FIVE Validation booth! We’d love to connect with you at Hall 15 / C36 in the Dutch Pavilion, NL Health~Holland. If you’re in the Life Sciences sector and interested in advanced validation tools and services with GO!FIVE? for both GxP-compliant AI and traditional technologies, be sure to stop by! ? Health~Holland is hosting two networking events today (Nov 12, 2024) and tomorrow (Nov 13, 2024) from 16:00 to 18:00. Join us to explore how our solutions can streamline your path to compliance, quality, and innovation. Let’s work together to create a smarter, more agile Life Sciences landscape. We look forward to seeing you there! #Medica2024 #LifeSciences #ValidationTools #GxP #Innovation #DigitalTransformation #AgileMethods #AI #Compliance #Dusseldorf #GoFive #VLMS #DigitalValidation #FiveValidation #TFHC #DutchPavilion #NLHealthHolland
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Visit FIVE Validation in MEDICA 2024 Dusseldorf! We’re thrilled to announce that we’re participating in Medica 2024, at Hall 15 / C36, Dutch Pavilion NL Health~Holland. For those in the Life Sciences sector looking for cutting-edge GO!FIVE? validation tool and services for both GxP-compliant AI and traditional technologies, we invite you to connect with us! Our expertise spans digital and agile methods that support every phase of the journey — from idea to patient. Whether you’re interested in innovative solution for validation in AI, or efficient methods for traditional processes, we’re here to discuss how we can elevate your projects. Stop by to discover how our solutions can streamline your path to compliance, quality, and innovation! Let’s connect and make improvements toward a smarter, more agile Life Sciences landscape. See you there! #Medica2024 #LifeSciences #ValidationTools #GxP #Innovation #DigitalTransformation #AgileMethods #AI #Compliance #Dusseldorf #gofive #VLMS #digitalvalidation #fivevalidation #TFHC #dutchpavilion #NLHealthHolland
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Exemplifying Machine Learning, in particular supervised models. If you need assistance in validation for AI and Non-AI systems, contact our specialist at [email protected] --- #machinelearning #supervisedlearning #aiassistance #fivevalidation #techvalidation #aitechnology #mlmodels #datascience #aidevelopment #aivalidation #techspecialists #aiandml #systemvalidation #datadriven #artificialintelligence
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Small and medium Life Sciences companies face the same validation regulatory requirements as larger organizations but often with fewer resources. Tight deadlines and audit pressures make compliance even more challenging. By adopting Agile methods for validation, teams can improve efficiency and our GO!FIVE? tool helps streamline these processes while ensuring full compliance. This allows teams to focus on higher-value tasks, meet deadlines, and minimize errors, rework, and regulatory risks. Want to learn more? Schedule a consultation with one of our specialists today! https://lnkd.in/dfjT_Vcq #validationsoftware #software #paperlessvalidation #pharmaceuticalindustry #lifescience #digitalvalidation