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FDA Title 21 CFR Part 11 compliance

Ensuring compliance with auditing and electronic signatures.

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Colabra is an R&D cloud platform that helps organizations comply with US Food and Drug Administration's Title 21 CFR Part 11, a regulation mandatory for any laboratory that operates in, or does business with a company in an FDA-regulated space.

Colabra has been designed to ensure the integrity, accuracy and reliability of electronic data, making it admissible for patent applications, and in the court of law in case of IP disputes. Its built-in compliant workflows help teams focus on their research instead of spending resources on compliance.

In this whitepaper, you'll learn about:

  • Meeting FDA 21 CFR Part 11 requirements
  • Enforcement by the FDA
  • Establishing ‘shop rights’ to an invention
  • Establishing inventorship and ownership rights
  • Defending against unnamed inventors
  • Protecting against the invalidation of a patent
  • Demonstrating novelty during patent prosecution
  • Simplifying legal compliance with Colabra
Remote collaboration between labs

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