The latest release of the Blackbelt Pro
supplies our Medical Device customers the ability to comply with 21 CFR Part 11 and EU Annex 11 requirements for storing and protecting electronic records.
Blackbelt Pro features that support 21 CFR Part 11 and EU Annex 11:
Unique User ID’s
250 unique User profiles may be stored within the instrument. User authentication requires a unique password and/or SmartKey for each user. Limits access for specific functions to permitted Users only.
Audit / Activity Log
A non-editable Audit Log is available from the instrument outlining events (logins/executions/edits time & date stamped) performed by all Users including Edit Reasons & Comments. Log entries are stored in onboard memory while the system stores all the activity with a built-in Autosave function.
Instrument Edit Comments
May be invoked to force users to enter Reasons & Comments when any changes are made to the instrument. Reasons & Comments are stored and reported under Audit/Activity Log.
PDF Report Generation
All reports such as Test Result Data, Program Configuration, Instrument Setup, Audit/Activity Log may be exported as a non-editable .pdf document.
The Administrator function of Blackbelt Pro allows the highest authorized user to assign and manage capabilities to other users in regard to: