Health Care Industry

Gives you an overview of how supports you in your Computer System Validation (CSV)

If you are working in the health care industry you are aware of the regulatory requirements for computer system validation, for example

  • FDA 21 CFR part 820.70

  • FDA 21 CFR part 11.10

  • FDA 21 CFR part 11

  • FDA guidance document regarding software validation

  • ISO 13485 (chapters 4.1.6, & 8.2.3)

  • GMP directives

  • ISO 14971

For development purposes you are also aware of EN 62304. enables you to fulfill those norms, as well as other national standards, with a 90% reduction of overhead.

It starts with the selection of our default execution cloud, the Microsoft Azure cloud, which complies with FDA CFR Title 21 Part 11 (Click here for more information). It continues with being able to provide you requirement documents for your validation efforts as well as a maintained open issues list per component for your SOUP assessment.

To comply with the regulations on electronic records we do provide a workflow that requires a trained V&V engineer to accept or reject any generated test results.

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