Product/Service

Software Supporting US FDA Electronic Signature Compliance

Source: LabVantage Solutions
The latest release of LabVantage Sapphire software fully supports US FDA 21 CFR Part 11 Electronic Signature, which can help users reduce transaction costs and leverage B2B market opportunities
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The latest release of LabVantage Sapphire software fully supports US FDA 21 CFR Part 11 Electronic Signature, which can help users reduce transaction costs and leverage B2B market opportunities.

In order to comply with US FDA issued regulations governing electronic signatures, the manufacturer states that the software offers the following features:

  • Ensures the uniqueness of each combination of user ID and password.
  • Verifies that an individual is allowed to perform a given system function.
  • Log failed access to the system (all log entries should include time/date, user ID, device ID, meaning of action, and success/failure).
  • Captures electronic signatures at "save" points, and records links to the signature in all database records.
  • Uses secure, computer-generated, time-stamped audit trails for creation/deletion/modification of electronic records.

LabVantage Solutions, 245 Highway 22 West, Bridgewater, NJ 08807. Tel: 908-707-4100, ext. 621. Fax: 908-707-1179.