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Is DicksonOne 21CFR Part 11 Compliant?

Yes. DicksonOne meets all requirements of the 21CFR11 (also 21CFR Part 11) codes/regulations.

21CFR11 has three main requirements:
  1. Access to the system and the data within is limited to specific users with their own passwords
  2. Data cannot be changed or manipulated in any way
  3. There must be an audit trail of all actions within the account
DicksonOne is perfectly in compliance with 21CFR11 requirements:
  1. Every user has their own account with their own password and is given specific permissions by an administrator.
    • Account administrators can specify password requirements for users.
    • Adding additional users and assigning permissions is easy!
  2. Data (both environmental and audit trail information) is unchangeable by any users, even the account administrator. Data cannot be altered by anyone while it is in the DicksonOne system.
  3. Every account has an easy-to-understand event log (same as audit trail) and includes every event and alarm that occurs within the system, any changes to settings, who made those changes, and what device received the changes (if applicable; changes can be made to the system's settings that don't affect one particular device, but the system as a whole.

For more information about 21CFR11 requirements visit the FDA's website.