CMM-Manager software functionality for 21 CFR Part 11

21 CFR Part 11 (FDA) Guidelines

What is 21 CFR Part 11?

21 CFR Part 11 is a regulatory framework designed by the FDA to guide drug and medical device makers on how to create, manage, and maintain electronic records (i.e. - CMM reports) and electronic signatures.

What CMM-Manager functionality supports 21 CFR Part 11 compliance?

Enhanced Global Security Settings

- Prevent unauthorized program and software changes
- Globally assign permissions including:
   - View, Modify, Run, Load and Save Programs
   - Change Preferences
   - Option for password protection



File Security

- Permissions to View, Modify, Run part program
- Password protection to change the permissions of a part program



Project revision history is saved in file with optional comments

 -Track revision history of each CMM-Manager Program / Project file
 - Revision info is added automatically to Program or Project files during Save (As)


Monitoring Settings / Event Logging

 - Monitor events such as Program Start, End, Error, Application Open / Close, Tip Calibration status, etc.



Example Event Log Contents:
{"_timestamp":"2024-10-01T11:35:27.518-0400","Program":{"state":"stop","reason":"program execution error - user aborted"}}
{"_timestamp":"2024-10-01T11:56:14.446-0400","Program":{"state":"start","reason":"normal"}}
{"_timestamp":"2024-10-01T11:56:14.446-0400","Program":{"info":{"program_name":"Part4","programmer":"N8","company":"QxSoft","date":"Oct 01, 2024  11:06 AM","description":""}}}
{"_timestamp":"2024-10-01T11:56:27.784-0400","Errors":{"message":"Program Execution Error: Operation: '003 3-2-1 Alignment' Error: 'Operation cancelled by user.'"}}
{"_timestamp":"2024-10-01T11:56:28.883-0400","Program":{"state":"stop","reason":"program execution error - user aborted"}}

What third-party software supports 21 CFR Part 11 compliance?

QC-Calc by Prolink - 21 CFR Part 11 Compliance

In the Administrative Tool for QC-CALC, the administrator sets up the Part 11 audit control creating valid users (or choosing LDAP) and reasons codes for changes in the application.

Part 11 Trackable Changes

Once enabled for a particular group, QC-CALC’s password protected audit functionality automatically triggers when there are:
Changes to the measured value
Changes to the measure date or time
Changes to the number of fails count
Changes to the name of any factor (non-measurement trace field)
Changes to the value of any factor (non-measurement trace field)
Deletions/undeletions of individual points
Deletions/undeletions of records (parts)
Remeasurements of a part.
Additions, removals, or display order changes of assignable causes
Additions, removals, or display order changes of corrective actions
Print actions of a signed report

Part 11 Account Management/Deactivation

Our convenient account management features allow you to set user account password expirations, activate/deactivate user accounts, and keep watch over the system. Optionally log failed login attempts by users and deactivate user accounts after a preset number of failures to prevent brute force password guessing. Upon deactivation, optionally notify an administrator via email of the deactivation so the administrator can take action. See screen shot on right.


Digital and Electronic Signatures

We chose to go beyond the Part 11 specification and offer support for both digital and electronic signatures when printing your report using the Signed PDF format.

Digital signatures are simply invisible wrappers placed around the document by Adobe Acrobat that verify the signer, the reason code, the time it was signed and that no changes have occurred to the document since it was signed. This is a part of the Part 11 specification and is shown at the bottom left of the report.

Read more here - Prolink Software - Features


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