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File extension index - KRN43a  Application notes and use cases
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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.

Topic

Requirement

NOTOCORD response

Security

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).

Traceability

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.