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From day one,
agile compliance
that empowers
your team!

 
24 de April de 2024

IT Infrastructure Qualification for Small & Medium Medical Devices Companies (and SaMD): ISO 13485:2016 Compliance

Networking opportunities are crucial at events, aren't they? However, many online events or webinars lack the chance for interaction not just with the speaker but also with fellow attendees, right?
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21 de August de 2023

FDA and EMA Trends for Computer System Validation (CSV) – Compliance Strategies

“By adopting agile methods, the aim is to save time, enhance agility, and avoid obstacles to innovation during the validation process.”, - Silvia Martins.
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25 de October de 2022

Challenges of SAP® Validation for Life Science Companies 

Perspective from Life Science SAP® user, Implementation Vendor, Project Manager, Validation Specialist, and Integrators.
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25 de March de 2022

Paperless Validation Q&A Session

Silvia Martins CEO and co-founder of FIVE Validation and Jon Nugent from CoursWorx have envisioned this session to help businesses better understand the importance of paperless validation.
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13 de October de 2020

Conducting Qualification and Validation in the Era of Covid-19

Qualification and Validation: Regulatory agencies such as FDA, EMA and WHO, require that the pharmaceutical, medical device and supply chain industries prepare documents that prove the proper functioning of processes, systems, and equipment. Read more.
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English

BR OFFICE

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sala 202, Condomínio Westpoint,
Parque Campolim | Sorocaba – SP – Brasil
Cep: 18.048-120
+55 15 3411-5550
[email protected]

USA OFFICE

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201 Washington Street | Boston, Massachusetts, Zip Code: 02108
[email protected]

EU OFFICE

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Mendelweg 32 | 2333 CS | Leiden, The Netherlands
+31 (0) 629 238859
[email protected]
  • Home
  • Institutional
    • About FIVE
    • Mission, Vision, Values
    • Projects
    • Policies and Certifications
      • Quality Policy
      • Information Security Policy
      • ESG practices
  • Expertise
    • Computerized System Validation
    • IT and OT Infrastructure Qualification
    • Equipment and Utilities Qualification
    • Data Integrity
  • Industry
    • Pharma Industry
    • Medical Devices
    • Clinical Trials
  • Products
    • Paperless Validation Software
    • Service Solutions
    • FIVE Academy
    • AI/ML Validation Lecture
  • Clients
    • Clients
    • Success case
    • Testimonials
  • Blog
    • Articles
    • Webinar
    • Awards
    • Events
  • Digital Validation
    • GO!FIVE® Software
    • Programs
      • GO!Startup
      • Partner Client
      • Be our Sales Rep!
      • Free Consultation
    • GO!FIVE® – Termos e políticas
    • GO!FIVE® Clients
  • Talk to Us
    • Schedule a meeting
    • Where We Are
  • Newsletter
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