Enhanced WinSPC security options ensure validity of collected data and uphold FDA 21 CFR Part 11 regulations
WinSPC Version 7.1 offers users a variety of password and audit trail settings to meet even the most stringent procedural requirements. Below are examples of controls in WinSPC to ensure system and data integrity.
Password and audit trail security options defined
WinSPC centralizes the administration of password security on an Audit/Security tab. Here are ten ways to customize your password security options using the Audit/Security tab settings:
1. Minimum password length
Specify the smallest number of characters that a password must contain.
2. Password mask
Define the format of acceptable passwords by using character-type specifications:
Spec Indicates the password character must be:
# A numeric digit (0-9)
A An uppercase letter (A-Z)
a A lowercase letter (a-z)
& An upper or lowercase letter (A-Z or a-z)
N An uppercase letter or numeric digit (A-Z or 1-9)
n A lowercase letter or numeric digit (a-z or 1-9)
? Any character
\ Identical to the character that follows the slash
3. Required password change every
Indicate a number of days after which a user is either reminded or required to change their password.
4. Password must be unique from previous
Stipulate that a password must be different from up to six previously used passwords.
5. Password changes allowed
Regulate the number of times a user can change their password within a specified number of days.
6. Maximum password failures allowed
Set the number of consecutive failed login attempts a station will tolerate before it locks.
7. Password required for administrative tasks
Require users to enter a password when attempting to perform an administrative task.
8. Password required to enter data collection
Require a password to go from the Navigator window into Data Collection.
9. Password required at beginning of each cycle in data collection
Require users to provide a password when beginning a data collection cycle.
10. Password required at end of each subgroup in data collection
Require a password each time a user completes the collection of a subgroup of data.
The Audit/Security tab also contains audit trail option settings. When the system audit trail is enabled, actions taken within the software are recorded. These events can then be viewed and filtered within the event log. A new feature included in Version 7.1 offers a setting to require users to enter a reason for the modifications they perform, providing an extra level of detail when auditing your processes.
For added security, check the Deleting events...check box to require any record deleted from the Event Log be archived to preserve the complete audit trail history. To learn more about event log filter criteria, click here.
Check the last check box in the Audit Trail Options pane to log Data Collection exceptions as well.
How to access the Audit/Security tab in WinSPC Version 7.1
On the Administrator window, from the menu bar, select Tools and then System Settings. On the System Settings dialog box that appears, click the Audit/Security tab. This tab is divided into the two parts discussed above, Password Options at the top and Audit Trail Options on the bottom.
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