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 Watchdog V5 and Electronics Records Compliance

 
 

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Icon Bullet Watchdog
Icon Bullet ViewPort
Icon Bullet V5 Central
Watchdog Version 5 is a tremendous improvement over version 4, particularly when it comes to FDA's Electronic Records/Electronic Signatures rule (21 CFR part 11).  This document shows examples of how this rule is implemented in Watchdog V5.

Summary

  1. All collected data resides in protected files so users cannot modify it.
  2. System requires login with unique name and password for each user.
  3. Forced password changes at designated intervals.
  4. Logins time-out after 10 minutes idle.
  5. Notes attached to events have the user name and time attached to them.
  6. On-screen indication of who is logged into the system.
  7. Complete audit logging of configuration changes.
  8. Ability to add explanatory notes to configuration changes.
  9. Visual indicators of changed fields so users can see what they are about to save.
  10. No automatic entry of data - prevents users from accepting default values or choices without thinking about them.
  11. Ability to access archived data using the system configuration that was in place when data was collected.


Discussion
  All collected data resides in protected files so users cannot modify it. Database files are password protected and no software comes installed on the system which can open the database files for viewing or editing.

  Watchdog V5 requires users to login with unique name and password. Passwords must be at least 5 characters long and contain both letters and numbers.


  Watchdog V5 forces users to change their password at designated intervals.

Administrator can determine when Watchdog passwords expire. In this case, the password would expire in 180 days, after which the user would have to create a new one.


 
  In order to prevent users accessing the system under some other user's login, the system automatically logs-off after 10 idle minutes.

  When users enter notes of any kind, their name, date and time of day are automatically added to the record.


 


 

  On-screen indication of who is currently logged into V5 Central. This helps users know if they are improperly using someone else's account.

The name of the person logged in is visible at all times.


  V5 has complete audit logging, so every change to a room configuration parameter is logged in a FROM/TO format. For example, High Critical Limit changed FROM 95 F TO 80 F. The user making the changes is also recorded along with the date and time. Audit logs cannot be turned off.

 

 

  To further aid users in the entry of data, screens will automatically indicate changed parameters both by changing color and turning on an indicator (*). This helps users see exactly what changes were made before they commit them to the system.

Here is a configuration screen before any changes have been made.

Here is the same screen after a change has been made to the High Critical setting. Note the changed field is blue in color and is flagged by an asterisk.

 

  The V5 Report Writer allows users to utilize historical configuration files when accessing archived data. As a result, additions or deletions of monitoring points will not affect the ability to recover any historical data.

 To facilitate record keeping, an optional note prompt appears as the user saves the changes, so a reason for the changes can be entered and added to the audit record.

 


  Watchdog V5 does not provide any automatic entry of data. This prevents users from accepting default values or choices without thinking about them.

 

Conclusion
Watchdog V5 complies with the FDA's Electronic Records rules. Furthermore, the quality of records and data that the system collects will be improved because the system is easier to use, lowering the risk of user error and requiring less training. Watchdog V5 also comes with a data conversion service to move from V4 to V5, which gives you access to historic data without having to maintain the V4 system. And archiving of V5 data can be streamlined, if desired, by giving the backup responsibility to your institutions IT department via your LAN. This can greatly enhance data security and help make sure back ups are done regularly.


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