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Computerized System Validation Lifecycle (GAMP 5)

The computerized system validation lifecycle, as defined by GAMP 5 (Good Automated Manufacturing Practice 5), follows a structured approach to ensure that computerized systems in the pharmaceutical and biotechnology industries meet regulatory requirements and perform reliably. This lifecycle consists of several key phases, each with its set of activities and deliverables. Here's an overview of the computerized system validation lifecycle according to GAMP 5:

1. Planning:

  • Objective: Define the scope and objectives of the validation project, including the identification of key stakeholders and regulatory requirements.
  • Activities:
    • Develop a Validation Plan that outlines the validation strategy, responsibilities, resources, and schedule.
    • Identify and document the criticality and category of the computerized system (e.g., Category 4 for bespoke software).
    • Establish the validation team and assign roles and responsibilities.

2. Risk Assessment:

  • Objective: Identify and assess potential risks associated with the computerized system and its impact on product quality, data integrity, and patient safety.
  • Activities:
    • Conduct a risk assessment to prioritize validation efforts based on risk.
    • Define risk acceptance criteria to guide validation activities.
    • Identify critical functions and data within the system.

3. User and Functional Requirements:

  • Objective: Document the user and functional requirements that the computerized system must meet.
  • Activities:
    • Develop User Requirement Specifications (URS) that outline user needs and expectations.
    • Create Functional Requirement Specifications (FRS) that detail the system's functionality.
    • Obtain approval and sign-off from relevant stakeholders.

4. System Design and Configuration:

  • Objective: Design the computerized system architecture and configure it to meet the specified requirements.
  • Activities:
    • Develop System Design Specifications (SDS) based on the approved FRS.
    • Configure the system to match the design specifications.
    • Ensure that all changes are documented and traceable.

5. Installation and Operational Qualification (IQ/OQ):

  • Objective: Verify that the system is installed correctly and operates according to design specifications.
  • Activities:
    • Perform IQ to confirm the proper installation of hardware and software components.
    • Execute OQ protocols to validate that the system functions as intended.
    • Document deviations and discrepancies and address them appropriately.

6. Performance Qualification (PQ):

  • Objective: Demonstrate that the system consistently performs within predefined operational limits in a simulated or real environment.
  • Activities:
    • Develop PQ protocols that define test scenarios and acceptance criteria.
    • Execute PQ tests using representative data and conditions.
    • Document and address any deviations or issues identified during PQ.

7. User Acceptance Testing (UAT):

  • Objective: Verify that the system meets user requirements and is ready for production use.
  • Activities:
    • Define UAT test cases and criteria based on user requirements.
    • Conduct UAT with involvement from end-users and stakeholders.
    • Obtain user acceptance and sign-off.

8. Change Control and Maintenance:

  • Objective: Implement and manage changes to the validated system while maintaining its validated state.
  • Activities:
    • Establish a change control process to evaluate and approve changes.
    • Document and validate any changes made to the system.
    • Conduct periodic reviews and revalidation activities as necessary.

9. Retirement and Decommissioning:

  • Objective: Safely retire or decommission the system when it reaches the end of its useful life.
  • Activities:
    • Develop a retirement plan outlining the steps for system retirement.
    • Archive and retain relevant documentation and data.
    • Conduct a final validation assessment and ensure data integrity.

Throughout the computerized system validation lifecycle, comprehensive documentation is essential to demonstrate compliance with regulatory requirements. The validation activities should be conducted following standard operating procedures (SOPs) and industry best practices to ensure that the system is fit for its intended purpose, maintains data integrity, and complies with Good Manufacturing Practices (GMP) and other relevant regulations.