MACSQuantify™ 21 CFR Part 11 option for data submission to the FDA

Enabling compliance for electronic records and signatures

The Subpart 11 of the Code of Federal Regulations Title 21 (21 CFR Part 11) defines the requirements for submitting electronic records to the FDA as well as criteria for using electronic signatures. The optional 21 CFR Part 11 software module of our MACSQuantify Software enables this by:

  • Time-stamped audit trails that are recorded for all data files, which record the creation, modification and storage of the files
  • Secure user login with password controlled inactivity time-outs, renewals and attempted sign-in failures.
  • Controlled electronic signatures as necessary for submissions to the FDA
  • Optional: Connection to existing LDAP system
Download PDF

Download the 21 CFR Part 11 statement to learn more about:

  • Controls for closed systems
  • Signature manifestations
  • Signature/record linking
  • Electronic signatures
  • Electronic signature components and controls
  • Controls for identification codes/passwords

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