21 CFR Part 11 Compliance
The control of inspection information as it applies to the medical industry is defined by FDA title 21 Code of Federal Regulations (21 CFR Part 11). QC-CALC’s data collection, storage, and reporting adhere to this important standard. Although this option has seen an increase in use by industries other than medical, it can be disabled for industries not requiring such strict control.
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. This screen is shown at right.
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 administator can take action. See screen shot on right.