Analytical Software Validation in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for validating analytical software used in analytical method development, ensuring that the software meets predefined requirements for accuracy, reliability, and data integrity.

2) Scope

This SOP applies to all personnel involved in the validation of analytical software for analytical method development projects within the analytical development department.

3) Responsibilities

The purpose of this SOP is to define the roles and responsibilities of all personnel involved in the validation of analytical software.

4) Procedure

1. Software Requirements Definition:
   1. Define user requirements for the analytical software, including functional, performance, and regulatory compliance criteria.
   2. Ensure alignment of software requirements with method development objectives and regulatory guidelines.
2. Installation Qualification (IQ):
   1. Verify and document that the software installation meets predefined specifications and requirements.
   2. Ensure compatibility with existing hardware and operating systems.
3. Operational Qualification (OQ):
   1. Perform testing to verify that the software functions according to operational specifications under normal conditions.
   2. Validate software functionalities such as data acquisition, processing, and reporting.
4. Performance Qualification (PQ):
   1. Evaluate software performance through simulated or actual use scenarios.
   2. Assess software reliability, accuracy, and data integrity under operational conditions.
5. Validation Report:
   1. Compile validation results and documentation into a comprehensive validation report.
   2. Include software validation protocols, test scripts, test results, and validation conclusions.
6. Review and Approval:
   1. Review the validation report for accuracy, completeness, and compliance with regulatory requirements.
   2. Obtain necessary approvals from stakeholders before finalizing and implementing the software for method development.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to analytical software validation in analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Software Validation Plan
• Installation Qualification (IQ) Records
• Operational Qualification (OQ) Records
• Performance Qualification (PQ) Records
• Validation Report

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• 21 CFR Part 11: Electronic Records; Electronic Signatures

8) SOP Version

Version 1.0