Equipment Validation Template

Use this Equipment Validation Template to confirm that machinery and tools meet all operational requirements, ensuring accuracy, safety, and compliance.

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Manufacturing
Equipment Validation Template

General Information

Documentation & Specifications

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Cleaning, Maintenance & Safety

Deviations & Corrective Actions

Final Approval & Sign-Off

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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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Equipment Validation Template

Use this Equipment Validation Template to confirm that machinery and tools meet all operational requirements, ensuring accuracy, safety, and compliance.

1. Equipment name, model, and unique ID/serial number:

2. Location:

3. Purpose or Intended use of the equipment:

4. Who are the responsible personnel (owner, operator, QA, maintenance)?

5. Validation protocol or reference document number:

1. Is the user requirement specification (URS) available and approved?

2. Is the equipment specification and vendor manual documented?

3. Have the design qualification (DQ) documents been reviewed and approved?

4. Are calibration certificates for instruments and gauges available?

5. Are material certificates and compliance reports attached?

1. Has the equipment been installed as per the manufacturer’s requirements?

2. Are all utilities (power, water, gas, compressed air, etc.) correctly connected?

3. Are safety features, guards, and emergency stops in place?

4. Is the equipment identification plate legible and accurate?

5. Has the installation been verified against layout drawings?

1. Were functional checks performed as per operating procedures?

2. Does the equipment respond correctly to control inputs?

3. Are operating ranges (temperature, speed, pressure, etc.) within limits?

4. Are alarms, sensors, and interlocks working correctly?

5. Has repeatability and consistency been demonstrated under test runs?

1. Does the equipment perform as intended under real operating conditions?

2. Were trial runs performed using actual materials/products?

3. Were critical process parameters maintained within specification?

4. Did output quality meet pre-defined acceptance criteria?

5. Was performance monitored over a defined period to confirm reliability?

1. Are cleaning and sanitation procedures validated and documented?

2. Are preventive maintenance schedules in place and verified?

3. Are operator safety instructions clear and implemented?

4. Are lockout/tagout procedures available where applicable?

5. Has risk assessment been performed and documented?

1. Were any deviations recorded during validation activities?

2. Were corrective actions implemented and documented?

3. Were re-tests conducted if required?

4. Were all deviations closed before final approval?

5. Is a summary of deviations included in the final report?

1. Has the validation summary report been prepared?

2. Has QA reviewed and approved the validation results?

3. Have all responsible parties (engineering, QA, operations) signed off?

4. Is the equipment released for routine use?

5. Are validation records stored in compliance with regulatory requirements?