A comprehensive list of audit trail events that are captured (software version 5.1.4.2004)
Rudolph Autopol IV, V, V Plus
21CFR11 Audit Trail Events
MENU
METHODS
- ADD METHOD
- EDIT METHOD
- DELETE METHOD
- 'Method1' was unloaded and 'Method2' was loaded by Administrator
MENU > OPERATIONAL PARAMETERS > COMMUNICATION SETTINGS
ENABLE PRINTING
- Enable Printing Changes
FORMAT PRINTING/OUTPUT
- Format Printing/output Changes
- User Field Changes
- Field Name Changes
- Prompt Option Changes
- Print Option Changes
FILE EXPORT OPTIONS
- Data Path Changes
- FILE NAMING OPTIONS Changes
- Option changed
- User Defined_File Order changed
- User Defined_Attribute changed
- User Defined_Attribute Delimiter changed
- User Defined_Date Delimiter changed
- User Defined_Date Format changed
- InstrumentID changed
- NETWORK DRIVE MAPPING
Add
Edit
Delete
COMMUNICATION LOG
- Communication Log Changes
MENU > OPERATIONAL PARAMETERS
TIME DATE
- Date is changed
- Time is changed
- Synchronize option changes
MENU > CALIBRATION AND SERVICE > CALIBRATION
QCP ADJUSTMENT
- QCP Calibration Settings Changes
- Measure/Calibrate was done
QCP DATABASE
- Add
- Edit
TEMPERATURE CALIBRATION
- Temperature Calibration was started
- Temperature calibration was aborted
- Temperature Calibration was ended
- Temperature calibration failed
- For Left Peltier Sensor, known values 1
- For Left Peltier Sensor, known values 2
- For Left Peltier Sensor, measured values 1
- For Left Peltier Sensor, measured values 2
- For Right Peltier Sensor, known values 1
- For Right Peltier Sensor, known values 2
- For Right Peltier Sensor, measured values 1
- For Right Peltier Sensor, measured values 2
- For Sample Peltier Sensor, known values 1
- For Sample Peltier Sensor, known values 2
- For Sample Peltier Sensor, measured values 1
- For Sample Peltier Sensor, measured values 2
- Coefficient values changes(b, m, a)
- Previous temperature calibration was abruptly aborted. Coefficients are reset after
instrument/software restart
MENU > CALIBRATION AND SERVICE > CALIBRATION > QCP VERIFICATION
PERFORM VERIFICATION
- Verification started by
- Verification completed
- Calibration verification is aborted due to communication lost
- QCP Verification terminated by
VERIFICATION HISTORY
- Verification detailed report exported to
- Verification summary report exported to
VERIFICATION SETTINGS
- QCP Verification Settings Changes
MENU > CALIBRATION AND SERVICE > CALIBRATION > TEMPERATURE VERIFICATION
PERFORM TEMPERATURE VERIFICATION
- Temperature Verification was started by
- Temperature Verification was completed
- Temperature Verification terminated by
- Temperature verification is aborted due to communication lost
MENU > CALIBRATION AND SERVICE
DARK SAMPLE SETTINGS
- Dark Sample Timer changes
GLOBAL SETTINGS
- Data Storage changed
MENU > CALIBRATION AND SERVICE > INSTRUMENT SETTINGS
CONTROL PANEL
- User has gone into the Windows Control Panel and actions while in Windows Control Panel are not logged
LAMP LIFE
- Hours of operation was reset
- Lamp life settings changes
MENU > CALIBRATION AND SERVICE > INSTRUMENT SETTINGS > BACKUP AND RESTORE
BACKUP
- A backup was performed
CONFIGURE
- Path Changes
- Number of Backups to retain changes
RESTORE
- A database restore was performed with backup dated
SET AUTO BACKUP
- Backup Day set to
- Backup Time set to
MENU > 21CFR11
AUDIT TRAIL
- Audit Trail was exported to
- Audit Trail backup was created to
REVIEW RESULTS
- Measurement done at 6/15/2022 10:10:00 AM is reviewed by
CHANGE USER PASSWORD
- User password changes
MENU > 21CFR11 > 21CFR11 ADMIN OPTIONS
SET 21CFR11
- Enable 21CFR11 changed
- Enable Operator changed
- Enable reviewer changed
- Delayed review changed
- Allow user to review their own results changed
- Enable Audit Trail Comment changed
- Require History Password changed
- Instrument Start
PASSWORD SETTINGS
- Password settings changes
- Password Complexity – UpperCase Enabled/Disabled
- Password Complexity – LowerCase Enabled/Disabled
- Password Complexity – Number Enabled/Disabled
- Password Complexity – Symbol Enabled/Disabled
TERMINOLOGY
- Accept Terminology changed
- Reject Terminology changed
LOGIN/LOGOUT
- Single Login changed
- Login for each Measurement changed
- Login for each Review changed
- Login for Menu access changed
MENU > 21CFR11 > 21CFR11 ADMIN OPTIONS > USER / GROUPS
ADD / EDIT USERS
- Add
- Edit
- Inactivate/Reactivate
ADD / EDIT GROUPS
- Add
- Edit
- Delete
MENU > 21CFR11 > 21CFR11 ADMIN OPTIONS > AUDIT TRAIL BACKUP
ARCHIVE SETTINGS
- Audit trail archive performed from “” to “”Performed by
- Archive Settings Changes
BACKUP SETTINGS
- Backup Type set to
- Event Count set to
- Backup Day set to
- Backup Time set to
- Backup Location set to
- Show message to user during export is enabled
MENU > RESOLUTION / UNITS
- Optical Rotation resolution changed
- Specific Rotation resolution changed
- Concentration resolution changed
- Deg_Z resolution changed
- Temperature resolution changed
- Concentration Unit changed
MENU > HISTORY
VIEW
- User "" went to data History
- User " " viewed measurement taken on
PRINT
- User " " printed measurement taken on
- Automatically printed measurement taken on
LIMS EXPORT
- User " " exported measurement taken on " " to LIMS
LOGIN
- Login failed due to invalid password
- “”account was locked due to too many invalid attempts
MEASUREMENT
- Measurement was started by
- Measurement terminated due to sample out of range
- Measurement terminated due to Screen Lock - Readings Out Of Range
- Measurement terminated due to screenlock
- Measurement completed and not reviewed due to screenlock.
- Measurement completed and waiting to be reviewed
- Measurement completed and reviewed by
- Measurement completed. Results file “”.pdf created
- Measurement was terminated by
SCREENLOCK
- Screen Locked
- Screen Unlocked
SINGLE LOGIN
- Administrator has logged in
- Administrator has logged out
MENU > OPERATIONAL PARAMETERS > AUTOFILL / BUBBLE INSPECTION
AUTOFILL SETTINGS
- Autofill settings changes
BUBBLE INSPECTION SETTINGS
- Bubble Inspection settings changes
MENU > CALIBRATION AND SERVICE > SERVICE / FACTORY SETTINGS
DEBUGGING
- Debug Log Enabled changed
- Debug Log IP changed