Page tree
File extension index - KRN43a  Application notes and use cases
Skip to end of metadata
Go to start of metadata

In a GLP environment, 21 CFR Part 11 rules require electronic records and electronic signatures to be trustworthy, reliable and secure. NOTOCORD-hem Evolution® enables GLP & 21 CFR Part 11 compliance thanks to AccessManager and LabManager (for video data streams), two dedicated and license-dependent applications (details available in AMG50a and LMG10a reference documents).

The table below presents key features available in NOTOCORD-hem Evolution®, with the AccessManager application, to address GLP requirements. This list is non-exhaustive.



NOTOCORD response


Limited system access to authorized individuals

  • User identification managed by Windows Group Policy and Active Directory.
  • User access to NOTOCORD-hem functions controlled by AccessManager strategy.


Records protection

Dedicated data manager account to protect data access (restricted access to data folder).


Recording of user actions in an electronic Audit Trail

  • Automatic recording of all actions inducing data creation, modification and deletion.
  • For each action: recordings of:
    • date and time,
    • action name and category,
    • name of user who executed the action,
    • comments,
    • old and new values.
  • Audit trail embedded in the NSS data file.
  • Audit trail report print function.


Recording of administrative actions

AccessManager modifications registered in Windows Event Log.