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7 de December de 2021

Return on Investment – Paperless Validation Approach

Return on investment, or ROI, is a financial metric used to measure the returns obtained from a given amount of invested resources.
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4 de October de 2021

System Validation leaves paper behind, projecting us into the digital era.

Probably we still validate using paper because we are used to it because it is the only way we know how to do it or because most companies still do so.
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24 de September de 2021
drug traceability serialization

Track and Trace for Pharmaceuticals in Brazil

In general, the serialization and traceability projects consist of obtaining information from each commercial drug unit in its entire chain.
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16 de August de 2021

What is paperless validation?

Paperless validation is an electronic process of ensuring that equipment, software, spreadsheet, utilities, cleaning, and processes.
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22 de January de 2020
SAP ECC HANA

SAP ECC® and SAP HANA® – Technical Upgrade

One of the most used systems in industries is ERP (Enterprise Resource Planning), which is the platform through which, among other functionalities.
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22 de January de 2020
paperless validation

What is Computer System Validation – CSV?

The validation proves with documentation that computer systems used in industrial production adequately fulfill their automatic functions and contribute to ensure the traceability of produced batches and meets GMP regulations.
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22 de January de 2020
LIMS-Laboratory-Information-Management-System

LIMS – Laboratory Information Management System

Laboratory Information Management Systems are quality control laboratory systems responsible for collecting and managing the flow of analytical data, approval of analyzes, traceability of samples and reagents, maintenance records.
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22 de January de 2020

Data Integrity in the Pharmaceutical Industry

Motivated by an increase in the number of nonconformities in the Pharmaceutical Industry, regulatory agencies have issued guidance in recent years on how to keep intact critical data.
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22 de January de 2020
data-integrity-automated-system

Ensuring Data Integrity in Automation Systems in the Life Science Industry

The concept of critical data integrity generated in production requires that a complete, consistent, accurate data throughout its life cycle is maintained.
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22 de January de 2020

Blockchain and Data Integrity in Computer System Validation

Blockchain was created in 1991 but it became known only in 2009 with Bitcoin. It aimed to be a viable alternative to financial relations that could be made directly between people.
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BR OFFICE

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[email protected]

BR OFFICE

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Sala 202, Condomínio Westpoint
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+55 15 3411-5550
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EU OFFICE

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Mendelweg 32 | 2333 CS | Leiden, The Netherlands
+31 (0) 629 238859
[email protected]

USA OFFICE

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201 Washington Street | Boston, Massachusetts
Zip Code: 02108
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  • 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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