Preventive Maintenance

Preventive maintenance (PM) refers to the scheduled, routine maintenance tasks performed on equipment to prevent failures, extend service life, and ensure consistent, reliable performance. In a 503B sterile compounding facility, PM is a critical component of equipment qualification. Regulators expect that equipment is not only calibrated but also mechanically maintained according to a defined, documented schedule. Clarix tracks PM schedules separately from calibration, reflecting the operational distinction between the two activities.

Calibration vs. preventive maintenance

It is important to understand the difference between calibration and PM, as they are separate regulatory requirements:

A balance, for example, requires both annual calibration (to verify it measures accurately) and periodic cleaning, leveling checks, and internal mechanism servicing (PM). An autoclave requires calibration of its temperature and pressure sensors as well as PM tasks such as door gasket inspection, drain strainer cleaning, and safety valve testing.

Viewing PM schedules for an asset

Open any asset's detail page (Equipment → Assets → [Asset Name]) and click the PM Schedules tab. This tab lists all PM schedules configured for that asset. Each schedule shows:

• The PM schedule name
• The frequency in days
• The date of the last completion
• The date the next PM is due
• The assigned technician

Creating a PM schedule

1. On the asset detail page, click the PM Schedules tab.
2. Click New PM Schedule.
3. Enter a Name for the schedule. Be descriptive — for example, "Quarterly Filter Replacement" or "Annual Door Gasket Inspection." Staff will see this name on their task lists.
4. Enter the Frequency (days) — the number of days between required PM completions. For example, 90 days for a quarterly task, 180 for semi-annual, 365 for annual.
5. Enter a Description that explains exactly what tasks need to be completed during this PM. This becomes the work instructions for the technician. Include specific steps such as:
   • Check and clean internal mechanism
   • Inspect door seals for cracks or deformation
   • Test emergency shutoff function
   • Lubricate moving parts per manufacturer SOP
6. Select the Assigned Technician from the user list. This is the person responsible for performing and signing off the PM task.
7. Click Save to create the schedule. The system immediately calculates the first due date.

PM tasks on the equipment dashboard

All PM tasks due within the next 30 days appear on the Equipment Dashboard in the PM Tasks Due Soon list. Each item in this list shows the asset tag, asset name, PM schedule name, due date, and assigned technician. This list gives supervisors and QA staff a forward-looking view of the PM workload so that staffing and vendor visits can be planned accordingly.

Logging a PM completion

When a PM task has been completed, log it in Clarix to update the record and schedule the next occurrence:

1. Open the asset detail page and navigate to the PM Schedules tab.
2. Click Log Completion next to the relevant PM schedule.
3. Enter the Date Completed — the date the maintenance was actually performed.
4. Add Completion Notes describing what was done, any findings, and any parts replaced. If a part was replaced, record the part number and lot number if applicable.
5. Enter your Facility PIN to sign the PM completion record.
6. Click Save Completion.

The system records the completion, calculates the next due date (completion date + frequency), and removes the task from the due-soon list on the dashboard.

PM history

The PM Schedules tab shows a history of all past completions for each schedule, including the completion date, the signing technician, and any notes recorded at the time. This history is part of the asset's qualification record and may be reviewed during FDA inspections or audits.

Why PM records matter

Unplanned equipment failures in a sterile compounding environment can result in batch losses, contamination risk, and production downtime. More importantly, poor PM documentation is a compliance risk. FDA investigators routinely request PM logs for critical equipment such as autoclaves, HVAC systems, and isolators. A documented, current PM program demonstrates that your facility has a functioning quality system — not just on paper, but in practice.

Role required: All staff can view PM schedules and history. Creating PM schedules and logging completions requires the Equipment Manager or Admin role.

Related pages

• Calibration
• Asset Registry
• Equipment Overview