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
