Standard Operating Procedure for Computer System Validation

1) Purpose

This SOP outlines the procedures for validating computer systems used in pharmaceutical manufacturing, testing, control, and documentation processes to ensure data integrity, reliability, and compliance with regulatory requirements.

2) Scope

This SOP applies to all computerized systems that manage or control GxP (Good Practice) activities, including but not limited to manufacturing execution systems (MES), laboratory information management systems (LIMS), electronic document management systems (EDMS), and quality management systems (QMS).

3) Responsibilities

The IT department or designated personnel are responsible for planning, executing, and documenting computer system validation activities. Quality Assurance (QA), Validation, and other relevant departments are responsible for providing support and ensuring compliance with validation requirements.

4) Procedure

4.1 Risk Assessment and System Classification

1. Perform risk assessment to determine the criticality and impact of the computer system on product quality, data integrity, and patient safety.
2. Classify computer systems based on risk assessment findings (e.g., critical, non-critical) to determine validation strategy.

4.2 User Requirements Specification (URS)

1. Develop User Requirements Specification (URS) document detailing functional and operational requirements of the computer system.
2. Include security, data integrity, audit trail, and user access requirements.

4.3 Installation Qualification (IQ)

1. Verify and document that the computer system and its components are installed correctly as per manufacturer specifications.
2. Ensure compatibility with existing IT infrastructure and security policies.

4.4 Operational Qualification (OQ)

1. Verify and document that the computer system functions as intended in all operational scenarios.
2. Test system functionality, interfaces, and performance under controlled conditions.

4.5 Performance Qualification (PQ)

1. Verify and document that the computer system performs reliably and consistently in a production environment.
2. Perform simulated or live data tests to demonstrate system compliance with predefined acceptance criteria.

4.6 Validation Report

1. Compile validation documentation, including protocols, test results, and deviations.
2. Review and approve the validation report to confirm compliance with validation objectives and regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
GxP: Good Practice (e.g., GMP, GLP, GDP)
IT: Information Technology
QA: Quality Assurance
LIMS: Laboratory Information Management System
EDMS: Electronic Document Management System
QMS: Quality Management System

6) Documents, if any

Risk Assessment Report, User Requirements Specification (URS), Installation Qualification Protocol, Operational Qualification Protocol, Performance Qualification Protocol, Validation Report

7) Reference, if any

Regulatory guidelines such as FDA Guidance for Industry – Computerized Systems Used in Clinical Investigations, EMA guidelines, ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients)

8) SOP Version

Version 1.0