Computer System Validation (CSV) Solutions

Computer System Validation (CSV) Solutions
Product Description

ProPharma's validation professionals leverage the latest risk-based Computer System Validation (CSV) and Computer Software Assurance (CSA) techniques to ensure that our clients' systems are ready for inspections from the FDA, EMA, MHRA, and other regulatory agencies. Our consultants have extensive experience in the pharmaceutical, biotech, medical device, clinical research, and software industries. - Cloud-based (SaaS and PaaS) applications - Configured Off-the-Shelf (COTS) applications - On prem and cloud-based (IaaS) infrastructure - Initial validation, retrospective validation, and ongoing validation for software updates

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ProPharma Group

  • Country/Region:
    Netherlands
  • On CPHI since:
    2022
  • Certificates:
    5
  • Employees:
    1000 - 4999
Company types
Consultancy
Contract Research Organisation (CRO)
Contract Service
IT/Software solution provider
Primary activities
Biopharmaceutical
Clinical Research
Contract Research Organisation
Regulatory Affairs
Supply Chain
Technology
View company profile
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ProPharma Group

  • Country/Region:
    Netherlands
  • On CPHI since:
    2022
  • Certificates:
    5
  • Employees:
    1000 - 4999
Company types
Consultancy
Contract Research Organisation (CRO)
Contract Service
IT/Software solution provider
Primary activities
Biopharmaceutical
Clinical Research
Contract Research Organisation
Regulatory Affairs
Supply Chain
Technology
View company profile

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ProPharma Group resources (1)