EasyMatchQC ER Software Q&A Follow

Access privileges

To comply with FDA 21 CFR Part 11, deletion by any user (admin or regular) is strictly disallowed. Features related to deletion are permanently grayed out in the Access Privileges settings (EZMQC ER Options > System Configuration > Access Privileges). For other available access privilege features, customers can adjust settings to meet their specific needs.

Default access privileges are preconfigured for both user and admin groups. However, customers retain the flexibility to customize these settings as required.

E-signature 

By default, the E-signature feature is disabled (grayed out) for accounts in user groups. It can be enabled in Access Privileges if necessary. Once enabled, users with E-signature access can sign jobs. The system supports multiple E-signatures from different users for the same job.

E-signatures are stored in the job. Users can view or print the audit log of the job to track activities performed before or after the E-signature. To include E-signatures in a job report, simply add a footer in the print setup. All E-signatures will then appear in the footer section of the report.

Audit Trail

There are two types of audit trail, audit log and event log.

Audit log captures and records all steps performed within a job, such as naming standards or samples. These records are stored sequentially in each job, along with descriptive details. Below is a list of activities recorded in the audit log:

• Save Job
• Standardization (including adding and switching modes)
• Read Sample/Standard
• Rename Sample/Standard
• E-Signature
• Print

Event log records actions performed by users outside a job. These steps are associated with codes for different application operations. A comprehensive list of event log codes can be found here.

The event log is stored in the Windows Event Viewer, which offers an auto-archiving option for selected logs in native file formats (.evtx or .evt) when the log reaches capacity.

Example: To configure auto-archiving for EZMQC application event logs:

1. Open the Event Viewer.
2. Expand Application and Services Logs.
3. Select EasyMatchQC, right-click, and choose Properties.
4. Refer to the attached screenshot for detailed guidance.

Data Storage

Each measurement is saved within a job file. If the "AutoSave Measurement" option is enabled in EZMQC ER Options > System Configuration > Data Storage, the measurement will also be saved in the database.

In EZMQC ER > Options > System Configuration > Data Storage, you can:

• Configure the database (MS Access or SQL).
• Use a local or network-based database. Detailed setup instructions for configuring an EZMQC SQL database are available here.

To save measurement to database, make sure that "AutoSave measurement" is checked.

To setup Auto backup EZMQC ER files into a network drive, enable EasyMatchQC User Files Backup and specify the network path. The backup will be created automatically:

• Every time the application is closed.
• At regular intervals (in days) as configured in the "Backup Interval" option. The first backup occurs immediately after saving the configuration in the Data Storage dialog.
• If the application remains open, backups occur every three days regardless of the configured interval.