type="1">

System Selection:

• Select a GMP-compliant digital monitoring system with real-time tracking capabilities for temperature, humidity, and pressure.
• Ensure the system has data backup and alert mechanisms for deviations.

Installation:

• Install sensors in strategic locations throughout storage areas to cover all critical points.
• Document installation details in the Digital System Installation Log (Annexure-1).

System Validation:

• Conduct system validation tests to ensure accuracy and reliability.
• Record validation results in the System Validation Report (Annexure-2).

5.2 Daily Monitoring and Alert Management

1. Monitoring Process:
   • Check the digital dashboard daily for temperature, humidity, and pressure readings.
   • Set automated alerts for deviations beyond specified thresholds.
   • Record daily readings in the Digital Monitoring Log (Annexure-3).
2. Alert Management:
   • Respond to system alerts immediately to prevent material compromise.
   • Document alert details and corrective actions in the Alert Response Log (Annexure-4).

5.3 Data Integrity and Backup

1. Data Integrity:
   • Ensure all data entries are timestamped, accurate, and unalterable.
   • Enable user authentication to control access to the digital monitoring system.
   • Record data integrity audits in the Data Integrity Audit Log (Annexure-5).
2. Backup Procedures:
   • Perform automatic data backups daily to a secure, cloud-based server.
   • Conduct monthly manual backups to an external storage device.
   • Document backup activities in the Data Backup Log (Annexure-6).

5.4 System Maintenance and Troubleshooting

1. Routine Maintenance:
   • Perform monthly software updates and calibration of sensors.
   • Clean sensors and ensure they are free from obstruction or damage.
   • Document maintenance in the System Maintenance Log (Annexure-7).
2. Troubleshooting:
   • Identify system errors using diagnostic tools provided by the manufacturer.
   • Report unresolved issues to the IT department for escalation.
   • Record troubleshooting efforts in the Troubleshooting Log (Annexure-8).

5.5 Training and Compliance

1. Training Program:
   • Conduct bi-annual training sessions for warehouse personnel and QA staff on system use and data interpretation.
   • Maintain training records in the Digital Monitoring Training Log (Annexure-9).
2. Regulatory Compliance:
   • Ensure digital monitoring practices align with FDA, WHO, and GMP guidelines.
   • Conduct quarterly audits and document results in the Regulatory Compliance Audit Log (Annexure-10).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• IT: Information Technology
• IoT: Internet of Things

7. Documents

1. Digital System Installation Log (Annexure-1)
2. System Validation Report (Annexure-2)
3. Digital Monitoring Log (Annexure-3)
4. Alert Response Log (Annexure-4)
5. Data Integrity Audit Log (Annexure-5)
6. Data Backup Log (Annexure-6)
7. System Maintenance Log (Annexure-7)
8. Troubleshooting Log (Annexure-8)
9. Digital Monitoring Training Log (Annexure-9)
10. Regulatory Compliance Audit Log (Annexure-10)

8. References

• 21 CFR Part 11 – Electronic Records; Electronic Signatures
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
• FDA Data Integrity and Compliance with CGMP Guidance

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Implementation	QA Head
06/04/2025	2.0	Updated with new monitoring protocols, data integrity measures, and digital backup procedures.	Regulatory Compliance Update	QA Head