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  • Types of Computerized Systems
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  • Validation Lifecycle (GAMP 5)
  • Specifications & Traceability
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  • 21CFR Part 11 Compliance
• Process Validation
  • Process Qualification Approach
  • General Principles (FDA Guidance)
  • Establishing Acceptance Criteria
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• Validation Approach
  • Validation Vital Role
  • Validation Steps, V-Model
  • Qualification Phases↓
    • Design Qualification
    • Installation Qualification
    • Operational Qualification
    • Performance Qualifications
    • Process Validation
  • Sequential Validation
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  • Validation vs Testing
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  • Change Control Impact
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Computerized System Qualification

The qualification of a computerized system, which includes Installation Qualification (IQ), Operational Qualification (OQ), and sometimes Performance Qualification (PQ), is closely related to the system's specifications, including the User Requirement Specification (URS), Functional Requirement Specification (FRS), and System Design Specification (SDS).

The qualification approach for a computerized system, including the extent and depth of validation activities, depends on the system's GAMP 5 category. Categories range from infrastructure software (Category 1) to tightly integrated hardware/software systems (Category 5). Lower categories may require simpler qualifications like Installation Qualification (IQ) and Operational Qualification (OQ), while higher categories may involve more comprehensive testing, including Performance Qualification (PQ) and User Acceptance Testing (UAT). The choice of category reflects the system's criticality to product quality and regulatory compliance, guiding the validation strategy and documentation process.

1. Installation Qualification (IQ):

• Objective: IQ verifies that the system is correctly installed according to the manufacturer's specifications and that it operates in the intended environment.
• Relationship with Specifications:
  • IQ protocols reference the System Design Specification (SDS) to ensure that the installation aligns with the system's design.
  • The URS and FRS may also be referenced to verify that the hardware and software components meet the intended requirements.

2. Operational Qualification (OQ):

• Objective: OQ verifies that the computerized system functions according to its functional specifications and that it can perform the intended operations reliably.
• Relationship with Specifications:
  • OQ protocols are closely tied to the Functional Requirement Specification (FRS). They validate that the system's functionalities, as outlined in the FRS, are working correctly.
  • OQ also examines the system against the Configuration Specification (CS) to ensure that any configured settings or parameters are correctly implemented.

3. Performance Qualification (PQ):

• Objective: PQ, which is not always required but can be, verifies that the computerized system consistently performs within specified operational limits in a simulated or real environment.
• Relationship with Specifications:
  • PQ protocols may reference the User Requirement Specification (URS) to ensure that user expectations are met during real-world usage.
  • In some cases, PQ can also be related to the Functional Requirement Specification (FRS) to validate critical functionalities under real-world conditions.

4. Traceability to Specifications:

Throughout IQ, OQ, and PQ, there is a strong emphasis on traceability. This means that each test and verification activity should be traceable back to the relevant specifications.

The Traceability Matrix is a document that links the individual test cases or protocols to the specific requirements or specifications they verify. It ensures that every requirement is tested and that no requirements are overlooked during the qualification process.

5. Change Control and Specifications:

After qualification, any changes made to the system must be evaluated against the original specifications. This is where the Configuration Specification (CS) becomes important. Changes to the system's configuration should be documented and validated to ensure they do not adversely affect the system's compliance with its specifications.

In conclusion, the qualification of a computerized system is a structured process that ensures the system meets its intended specifications and requirements. Each qualification phase (IQ, OQ, PQ) corresponds to specific types of specifications (SDS, FRS, URS) and aims to verify that the system functions correctly, reliably, and in accordance with these specifications. The Traceability Matrix helps maintain a clear and documented connection between requirements and qualification activities throughout the lifecycle of the computerized system.