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“headline”: “SOP for Device Accountability, Calibration and Maintenance”,
“description”: “This SOP outlines the standardized process for accountability, calibration, and maintenance of devices used in clinical trials, ensuring compliance with FDA, EMA, CDSCO, WHO, and ICH GCP requirements for investigational devices and trial-related equipment.”,
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Published on 21/12/2025
Standard Operating Procedure for Device Accountability, Calibration and Maintenance
| SOP No. | CR/OPS/106/2025 |
| Supersedes | NA |
| Page No. | 1 of 44 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
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
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
- Device Accountability Log (Annexure-1)
- Calibration Certificate File (Annexure-2)
- Maintenance Log (Annexure-3)
- Device Use Log (Annexure-4)
- 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
| Prepared By | Ravi Kumar, Clinical Engineer |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Clinical Operations |
Annexures
Annexure-1: Device Accountability Log
| Date | Device ID | Serial No. | Received By | Status |
|---|---|---|---|---|
| 01/09/2025 | ECG-100 | SN-2025-01 | Site Coordinator | Received |
Annexure-2: Calibration Certificate File
| Device ID | Calibration Date | Certificate No. | Vendor | Next Due Date |
|---|---|---|---|---|
| ECG-100 | 05/09/2025 | CAL-2025-22 | ABC Calibration Services | 05/09/2026 |
Annexure-3: Maintenance Log
| Date | Device ID | Activity | Performed By | Status |
|---|---|---|---|---|
| 10/09/2025 | ECG-100 | Preventive Maintenance | Engineer | Completed |
Annexure-4: Device Use Log
| Date | Device ID | Subject ID | Used By | Remarks |
|---|---|---|---|---|
| 15/09/2025 | ECG-100 | S101 | Study Nurse | Normal function |
Annexure-5: Device Disposal Log
| Date | Device ID | Disposal Method | Performed By | Status |
|---|---|---|---|---|
| 20/09/2025 | ECG-100 | Returned to Vendor | Site Coordinator | Closed |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Clinical Operations |
For more SOPs visit: Pharma SOP