Prolink is proud to announce that QC-CALC now meets or exceeds the requirements
to be 21 CFR Part 11 compliant. The following is a brief list of features that our
medical customers are now using in order to be Part 11 compliant. Not in the medical
industry? We're finding more and more customers in other industries are using the
auditing and digital signature features to improve their quality practices so
please
read on.
Auditing Capabilities
Once enabled, QC-CALC’s password protected audit
functionality automatically challenges
users for
a username, password, and reason code whenever there are changes to the data or requests to print
a digitally signed report.
Digital and Electronic Signatures
When running reports, QC-CALC allows the creation of digitally
signed Adobe PDF documents rather than standard reports. Assuming a password is
entered correctly, the report will run and be digitally signed ensuring the report
cannot be edited without breaking the signature. In addition, you can choose
to add a picture of your hand-written signature to the report so it is present when printed to
paper.
Account Management Features
QC-CALC's Part 11 account management features ensure security by
allowing you to log
failed password attempts, enforce password expiration, activate/deactivate user
accounts, and even email administrators when a user has deactivated his account
after multiple failed password attempts.
How To Get It:
If the Administrative Tools menu is present in QC-CALC 3.2, simply choose Help > Run Update to get the latest revision. If you do not have the Administrative Tools menu, please download the evaluation for
QC-CALC v.3.2 w/Admin Tool and follow the instructions in the Administrative Tool Explained Tutorial or attend one of our daily live web demonstrations. Installing over your current version of QC-CALC 3.2 will not change any of your settings.
There is no extra charge for the administrative tools or Part
11 functionality in QC-CALC 3.2.
If you have an earlier version of QC-CALC, now is a great time to upgrade to the
latest version to take advantage of all the new features in 3.2.
Want to Learn More?
View our 6 minute Getting Started video >>
Read our 21 CFR Part 11 compliance page >>
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