Pharmaceuticals, cold chain controls, internal audit
Documentation and Records
Temperature Monitoring Equipment
- Schedule inspections at defined intervals.
- Use certified calibration tools.
- Document calibration results in a log.
- Adjust settings according to manufacturer specifications.
- Retest equipment after adjustments.
- Identify critical areas requiring monitoring.
- Ensure equipment is away from heat sources.
- Place sensors at different heights as needed.
- Verify accessibility for maintenance.
- Document the locations in a facility map.
- Create a log for temperature deviations.
- Investigate causes immediately.
- Document findings and corrective actions.
- Review excursion data for trends.
- Report significant excursions to management.
- Develop a maintenance schedule.
- Assign responsibilities for servicing.
- Keep records of maintenance performed.
- Use only approved service providers.
- Review maintenance effectiveness regularly.
- Select a reliable centralized monitoring software.
- Ensure all equipment is properly integrated.
- Test data transmission regularly.
- Set alerts for temperature deviations.
- Train staff on using the monitoring system.
- Develop a training program.
- Include equipment operation and troubleshooting.
- Conduct hands-on training sessions.
- Provide written manuals and guidelines.
- Schedule refresher courses periodically.
- Establish an audit schedule.
- Use a checklist for equipment evaluation.
- Engage independent auditors if possible.
- Document audit findings and recommendations.
- Follow up on corrective actions from audits.
- Create handling guidelines to avoid damage.
- Store equipment in a controlled environment.
- Label storage areas clearly.
- Ensure equipment is deactivated when stored.
- Review procedures regularly for compliance.
Use in Manifestly