Data Integrity Risk Assessment Protocol for Software and SCADA System

1.0 INTRODUCTION

The purpose of this Data Integrity Risk Assessment (DIRA) is to systematically evaluate, identify, and mitigate risks related to data integrity issues associated with the operation of the system that generated both electronic and paper based records. This risk assessment follows the Failure Mode and Effects Analysis (FMEA) approach, ensuring compliance with:

• ICH Q9: Quality Risk Management
• ALCOA+ Principles for Data Integrity
• 21 CFR Part 11 (Electronic Records & Electronic Signatures)
• EU GMP Annex 11 (Computerized Systems)
• EU GMP Annex 15 (Qualification & Validation)
• WHO & MHRA Data Integrity Guidelines

2.0 PURPOSE

To assess the data integrity risks associated with the operation, maintenance, and data management of the HPLC that generated both electronic and paper based data by using the Failure Modes and Effects Analysis (FMEA) approach in compliance with ICH Q9.

3.0 SCOPE

This risk assessment applies to the entire lifecycle of HPLC data, including data acquisition, processing, storage, retrieval, and reporting. It covers software, hardware, user interactions, and procedural compliance related to data integrity principles, covering:

• Electronic Data Risks – Risks associated with data acquisition, processing, storage, access control, and audit trails.
• Paper-Based Data Risks – Risks related to manual transcription errors, document loss, unauthorized alterations, and reconciliation issues.
• Hybrid System Risks – Challenges in managing both electronic and paper records, ensuring consistency, and preventing compliance gaps.
• General Compliance & Operational Risks – Issues related to system qualification, user training, periodic reviews, and backup failures

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