SOP for Regulatory Data Integrity

Purpose

This SOP aims to set rules and processes to guarantee data integrity in regulatory actions. Throughout the regulatory procedures, including data generation, collecting, analysis, and reporting, it seeks to prevent illegal access, loss, change, or falsification of data. Respecting the principles of data integrity is crucial to preserving regulatory compliance and guaranteeing the accuracy and credibility of data that has been submitted.

Scope

All employees who work on regulatory projects, such as creating, gathering, analyzing, and reporting data, must follow this SOP. It includes all regulatory activities, including clinical trials, product registration, post-marketing surveillance, and quality control, and it applies to both paper-based and electronic data.

Responsibilities

Quality Assurance: 

• Create and oversee the Data Integrity Policy and associated protocols.
• Employees should receive training on data integrity best practices and principles.
• To make sure that the requirements for data integrity are being followed, conduct audits and inspections.

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Owners and custodians of data: 

• Make sure the data is generated or gathered with accuracy, completeness, and integrity.
• Put in place the necessary safeguards to stop unwanted access, alteration, or deletion of data.
• Keep data up to date in compliance with internal policies and any applicable legal requirements.

IT Department (if relevant):

• Create and manage safe electronic systems for backup, retrieval, and data storage.
• Put in place data encryption, audit trail features, and access controls.
• To guarantee the integrity and dependability of data systems, validate and monitor them regularly.

Regulatory Affairs Department:

• Ensure that regulatory submissions are supported by accurate and reliable data.
• Verify the integrity and authenticity of data submitted to regulatory authorities.
• Maintain proper documentation of data sources, transformations, and validations.

Procedure

Data Generation and Collection:

• Use validated and calibrated instruments and equipment for data generation.
• Follow standard operating procedures (SOPs) for data collection, including data entry and recording.
• Document all relevant information for each data entry or modification, such as date, time, and personnel involved.

Data Storage and Protection:

• Store electronic data in secure, validated systems with appropriate access controls.
• Implement data backup and recovery procedures to prevent data loss or corruption.
• Store paper-based records in controlled environments with restricted access and proper labeling.

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Data Integrity Controls:

• Implement access controls to ensure only authorized personnel can access, modify, or delete data.
• Use unique user accounts and strong passwords for system access.
• Maintain an audit trail of data changes, including the identity of the person making the change and the reason for the change.

Data Review and Approval:

• Perform regular data reviews to ensure accuracy, completeness, and compliance with regulatory requirements.
• Document data review activities, including any discrepancies or corrective actions taken.
• Obtain appropriate approvals for finalized data before submission to regulatory authorities.

Training and Awareness:

• Provide training to personnel on data integrity principles, including data entry, handling, and storage practices.
• Conduct periodic awareness programs to reinforce the importance of data integrity and regulatory compliance.

Abbreviations:

SOP: Standard Operating Procedure

Documents:

• Data Integrity Policy
• Data Integrity Procedure
• Data review and approval templates
• Audit trail reports and documentation

Annexure

Nil

Revision History

Nil

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