Overview
The PTC Tempo Thermal Cycler Security Edition Software is an on-instrument functionality that will assist customers in a regulated environment in meeting 21 CFR Part 11 and cybersecurity guidelines. For customers working in regulated laboratory environments, it addresses customer needs by offering traceability in the form of audit reports and signed run reports.
The Security Edition functionality is offered on all four models of the PTC Tempo, PTC Tempo 48/48, PTC Tempo 96, PTC Tempo Deepwell, and PTC Tempo 384 Thermal Cyclers. To activate the Security Edition features of the software, you will need one (1) license per instrument.
Features & Benefits
- Run and copy protocols, generate and export run reports, export logs as a PDF for audit purposes, and manage users based on user role (Administrator, Principal, or Operator)
- Lock protocols to protect them from unauthorized modifications
- Authorization verification through user IDs and passwords to ensure appropriate permissions for specific functions
- Time- and date-stamped run reports and system logs that record user activity, run activity, and thermal cycler operations (such as pausing, skipping, and stopping a run)
- Electronic signature capability for run reports to ensure authenticity
- Lock the PTC Tempo Thermal Cycler to protect in-progress protocol runs
- Disable the PTC Tempo Thermal Cycler USB drive
Configuration Options
| System Types | Catalog Number |
| PTC Tempo 96 Thermal Cycler | 12015382 |
| PTC Tempo Deepwell Thermal Cycler | 12015392 |
| PTC Tempo 48/48 Thermal Cycler | 12015309 |
| PTC Tempo 384 Thermal Cycler | 12015394 |
User Roles and Permissions
| Description | Administrator | Principal | Operator |
| Enable security edition, system management, update software, network settings, perform factory reset | X | ||
| Connect to network folder | X | X | |
| Add new users, assign role to users, deactivate and activate existing users, reset passwords | X | ||
| Create, edit, lock, rename, save, and copy protocol; template protocol access | X | X | |
| Run, rerun, and delete unlocked protocol | X | X | |
| Run locked protocol; Run incubate protocol | X | X | X |
| Delete locked protocol (no one) | |||
| Lock and unlock their screen session | X | X | X |
| Unlock any screen session | X | ||
| Sign a run report | X | X | |
| Sign button on run report viewer, view run report, export only signed run reports | X | X | X |
| Delete system log that has been exported | X | ||
| Export system log PDF (audit trail, controlled document) | X | X | |
| Export signed run reports (controlled document), view system logs (audit trail) | X | X | X |
| Export diagnostic logs (system log, FW log for tech support) | X | X | X |
| Run set up - lid temperature and lid volume | X | X |
Documents
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