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Computerized System Validation Specifications, Protocols, Traceability Matrix

In computerized system validation, various types of specifications and validation protocols are written to ensure that the system meets its intended requirements and functions correctly. The specific types of specifications and protocols can vary depending on the nature and complexity of the system. GAMP 5 provides a framework for understanding these documents and their relationships, including the concept of a Traceability Matrix.

Types of Specifications:

  1. User Requirement Specification (URS):

    • Definition: The URS defines the high-level requirements and expectations of the system as seen from the user's perspective.
    • Validation Protocol: The User Acceptance Test (UAT) protocol verifies that the system meets the requirements outlined in the URS.
    • Reference: GAMP 5 Section 4.2.1.
  2. Functional Requirement Specification (FRS):

    • Definition: The FRS details the specific functionalities and features that the system must have to meet user needs.
    • Validation Protocol: The Performance Qualification (PQ) protocol may verify that the system functions in accordance with the FRS.
    • Reference: GAMP 5 Section 4.2.2.
  3. System Design Specification (SDS):

    • Definition: The SDS describes how the system is designed to meet the functional requirements and includes details about the system architecture.
    • Validation Protocol: The IQ/OQ protocols ensure that the system is installed and operates according to the SDS.
    • Reference: GAMP 5 Section 4.2.3.
  4. Configuration Specification (CS):

    • Definition: The CS specifies how the system is configured, including settings, parameters, and customizations.
    • Validation Protocol: Configuration qualification (CQ) or, in some cases, PQ may verify that the system is configured correctly.
    • Reference: GAMP 5 Section 4.2.4.
  5. Test Specifications (TS):

    • Definition: Test specifications provide detailed instructions on how to perform testing activities, including test cases and expected results.
    • Validation Protocol: Test scripts or protocols (e.g., IQ, OQ, PQ) are executed based on the test specifications.
    • Reference: GAMP 5 Section 4.2.5.

 Traceability Matrix:

Definition: A Traceability Matrix is a document that links different levels of requirements and specifications to corresponding test cases or protocols. It demonstrates the "traceability" of each requirement through the validation process.
Purpose: The Traceability Matrix helps ensure that all requirements are tested and that no requirements are overlooked during validation. It also aids in change control by showing the impact of changes on requirements and tests.
Reference: While not explicitly outlined in GAMP 5, traceability is a fundamental principle in validation and is supported by various regulatory guidelines, such as FDA's 21 CFR Part 11.

In addition to GAMP 5, pharmaceutical and biotech companies must comply with regulatory requirements, such as FDA's 21 CFR Part 11 (Electronic Records; Electronic Signatures) in the United States and EU GMP Annex 11 (Computerized Systems) in Europe, which provide further guidance on validation practices and documentation.