Electronic records, File security and validation – Bio-Rad Bio-Plex Software® Upgrades and Conversions User Manual
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Bio-Plex Manager Software 6.1 User Guide | Electronic Records
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Users are required to enter their user name and password when they:
•
Start the application
•
Start a reading
•
Unlock the application
•
Sign a document, such as a Protocol or Results file
Different users may authenticate operations. For example, a Clinician
1-level user may be logged into Bio-Plex Manager, but a Supervisor-level user
may enter his user name and password to authenticate a particular reading.
Note that in this case, the Clinician 1-level user will remain logged onto the
application.
Your organization must establish its own guidelines for user authentication of
specific operations.
Electronic Records
Bio-Plex Manager
Security Edition supports the creation and control of secure
“electronic records,” as defined by 21 CFR Part 11. In Bio-Plex Manager, the
following are electronic records:
•
Protocol files
•
Results files
•
Calibration Log (included in the bioplexdata.mdb file)
•
Validation Log (included in the bioplexdata.mdb file)
•
Instrument Operations Log (included in the bioplexdata.mdb file)
These records are accessible only through Bio-Plex Manager and its
associated utilities.
File Security and Validation
The files used by Bio-Plex Manager Security Edition cannot be opened or
edited using other programs. Bio-Plex Manager checks the integrity and
validity of a file each time it opens. If a file becomes damaged or shows signs
of tampering with an outside application, it will not open in Bio-Plex Manager.
BioPlex_6.book Page 130 Friday, September 23, 2011 11:55 AM