Part 11 Functionality

Total solution to FDA’s Part 11 requirements

• AS/400 based and using the available functionality of the operating system, DataThread ™does not require any modification to existing applications
• Highly configurable, able to identify at the file and field level, auditing and signature requirements
• Captures data changes into a secure auditable database
  • Capture the user id, user name, local time and date, before and after image of the data change
• Allows user to electronically sign for changes
  • Signature can be captured at time of change or grouped for signing at a later time
  • Multiple signatures can be required for the same change, allowing for work flow management and oversight.
  • Signature can be captured through biometric devices or passwords independent of the AS/400 password
• Provides user-friendly audit capabilities through electronic files, hard copy reports, and on-screen reports.
  • Auditable data from several AS/400 can be combined into network based data repositories for reporting and archiving
• Specifically developed for part 11, DataThread™has a very small footprint with efficiency as its cornerstone
• Infinitely scalable to the largest AS/400 environments