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.
Limited system access to authorized individuals
Dedicated data manager account to protect data access (restricted access to data folder).
Recording of user actions in an electronic Audit Trail
Recording of administrative actions
AccessManager modifications registered in Windows Event Log.