by What is Computer System Validation?
Computer system validation is the documented process of ensuring that software and computer systems work as intended and meet applicable regulatory requirements. It includes establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a result meeting predetermined specifications and quality attributes.
Requirements and Specifications
The first phase of Computer System Validation involves clearly documenting the functional and non-functional requirements and specifications of the computer system. This includes defining what the system is expected to do and ensure it will perform tasks accurately, reliably and safely. Key requirements related to integrity, traceability of data, accuracy of output reports, security and compliance are established at this stage. Any risks to quality or safety are also identified and addressed.
System Design and Development
In the design and development phase, procedures are put in place to ensure changes to the system design are properly reviewed and approved. Development practices like version control, code review, testing and validation are established to verify the system performs as intended during design, coding and unit testing. Processes are followed to evaluate the appropriateness of algorithms, calculations and logic used in the system.
Testing and Validation
Comprehensive testing is performed to confirm the computerized system meets predetermined specifications and user needs. Validation testing involves testing integrations between hardware, software, databases and other systems. Different types of testing like unit testing, integration testing, system testing and user acceptance testing are conducted. Test plans are documented to ensure coverage of all planned tests. Problems discovered are logged, addressed and verified to be fixed.
System Configuration Management
Effective configuration management verifies that the right versions of software, data, equipment and related items are deployed, maintained, and modified in a controlled manner. This ensures continuity of the validated state of the system as upgrades or changes are introduced over time. Configuration management also helps prevent issues from older invalidated versions of the system or related components.
Operational Qualification and Performance Qualification
With operational qualification and performance qualification, the operational state and performance of the computer system is confirmed. Operational qualification involves verifying the system is installed correctly and operates within established parameters. Performance qualification testing measures outputs to validate the system is performing tasks as intended in an actual operational environment. This helps ensure continued validity of the validation process.
Change Control
A formal change control system manages all modifications to the validated computerized system. Changes are categorized as minor or major based on risk assessment. All changes undergo documentation, review and approval as part of the validation protocol. Post change validation is conducted for changes deemed significant enough to potentially impact the original validation state of the system. Revised documentation reflects changes made to maintain evidence of the validated state over time.
Reviews and Auditing
Periodic management system reviews ensure continued compliance, suitability and effectiveness of the CSV processes. Internal audits validate proper implementation and documentation of validation activities. External independent audits provide additional assurance. Any issues or deficiencies identified are tracked and addressed to maintain the validated state over time.
CSV and Regulatory Compliance
Under regulatory frameworks like 21 CFR Part 11, computer systems used in regulated industries must be validated. CSV helps demonstrate compliance and data integrity for inspection by authorities. Validated systems also build confidence in software quality for internal and external stakeholders. By ensuring only validated versions are maintained and changes undergo proper controls, CSV facilitates compliance in highly regulated environments.
In summary, computer system validation establishes documented evidence that software performs as intended through a structured, controlled and compliant validation life cycle. It provides confidence in system integrity and helps organizations meet regulatory requirements for computerized systems. A well-designed and executed CSV protocol promotes quality, safety and compliance throughout the life of validated computer systems.
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1. Source: Coherent Market Insights, Public Source, Desk Research
2. We have leveraged AI tools to mine information and compile it.
