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Standard Operating Procedure for Device Accountability, Calibration and Maintenance

Purpose

The purpose of this SOP is to define standardized procedures for the accountability, calibration, and maintenance of devices used in clinical trials. Proper management of devices ensures reliability of data, subject safety, regulatory compliance, and inspection readiness.

Scope

This SOP applies to all investigational devices and equipment used in clinical trials, including diagnostic instruments, monitoring devices, laboratory equipment, and therapeutic devices. It covers device receipt, storage, accountability, calibration, preventive and corrective maintenance, documentation, and disposal.

Responsibilities

• Sponsor: Ensures overall compliance with device accountability and calibration requirements.
• Investigator/Site Staff: Maintain device logs, perform accountability, and ensure timely calibration and maintenance.
• CRA: Verifies device accountability during monitoring visits.
• QA: Reviews calibration and maintenance records for compliance.
• Vendors: Provide calibration certificates and maintenance support.

Accountability

The Principal Investigator is accountable for site-level device accountability, calibration, and maintenance. Sponsor QA is accountable for ensuring oversight and compliance across sites and vendors.

Procedure

1. Device Receipt and Accountability
1.1 Record device receipt in Device Accountability Log (Annexure-1).
1.2 Verify device identification, serial numbers, and condition upon receipt.
1.3 Store devices securely with restricted access.

2. Device Calibration
2.1 Calibrate devices prior to study initiation and at defined intervals.
2.2 Use qualified vendors or accredited laboratories.
2.3 Retain calibration certificates in Calibration Certificate File (Annexure-2).

3. Device Maintenance
3.1 Perform preventive maintenance as per manufacturer’s guidelines.
3.2 Record all maintenance activities in Maintenance Log (Annexure-3).
3.3 Address corrective maintenance promptly when malfunctions occur.

4. Device Use Tracking
4.1 Record device use in Device Use Log (Annexure-4).
4.2 Reconcile device usage with study records.

5. Device Disposal/Return
5.1 At study completion, return or dispose of devices per sponsor/vendor instructions.
5.2 Document in Device Disposal Log (Annexure-5).

Abbreviations

• SOP: Standard Operating Procedure
• CRA: Clinical Research Associate
• QA: Quality Assurance
• PI: Principal Investigator
• IDE: Investigational Device Exemption
• WHO: World Health Organization

Documents

1. Device Accountability Log (Annexure-1)
2. Calibration Certificate File (Annexure-2)
3. Maintenance Log (Annexure-3)
4. Device Use Log (Annexure-4)
5. Device Disposal Log (Annexure-5)

References

• ICH E6(R2/R3) – Device Management Standards
• FDA 21 CFR Part 812 – Investigational Device Exemptions
• EMA – Medical Device Trials Guidelines
• CDSCO – Device Accountability and Calibration
• WHO – Medical Device Accountability and Maintenance

Version: 1.0

Approval Section

Annexures

Annexure-1: Device Accountability Log

Annexure-2: Calibration Certificate File

Annexure-3: Maintenance Log

Annexure-4: Device Use Log

Annexure-5: Device Disposal Log

Revision History

For more SOPs visit: Pharma SOP