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Computerized-System-Validation

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Chí Nguyễn
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7 views9 pages

Computerized-System-Validation

Uploaded by

Chí Nguyễn
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPTX, PDF, TXT or read online on Scribd
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Computerized System

Validation
Ensuring the reliability and integrity of computerized systems in
regulated industries.

by Chí Nguyễn Tấn


Introduction to Computerized System
Validation
What is CSV? Why is CSV important?

CSV is a critical process used to demonstrate that a CSV ensures data integrity, compliance with
computerized system meets predefined requirements regulations, and patient safety in industries such as
and performs as intended. healthcare, pharmaceuticals, and biotechnology.
Regulatory Requirements
and Guidelines
FDA GMP
The Food and Drug Good Manufacturing
Administration (FDA) Practices (GMP) require
publishes guidelines for validation of computerized
computerized system systems to ensure product
validation in the quality and consistency.
pharmaceutical and medical
device industries.

GAMP
The Good Automated Manufacturing Practice (GAMP) provides
guidance on computerized system validation principles and
best practices.
Risk-Based Validation Approach
Risk Assessment
Identify potential risks and their impact on system performance and
1
compliance.

Risk Mitigation
2 Develop and implement strategies to reduce or eliminate risks,
ensuring system reliability.

Validation Scope
3 Define the scope of validation based on the identified
risks and critical system functions.
Validation Planning and
Documentation

Validation Plan Validation Protocol


Define the validation objectives, Outline the specific tests and
scope, methodology, and timeline. procedures to be conducted
during validation.

Validation Report
Document the results of the
validation activities and conclude
on system performance and
compliance.
Verification and Testing Strategies
Unit Testing
1
Test individual components of the system to ensure they function as expected.

Integration Testing
2
Verify the interactions between different components of the system.

System Testing
3
Validate the overall system functionality and performance.

User Acceptance Testing


4 Ensure that the system meets user needs and
expectations.
Qualification of Equipment
and Instruments

1 2
Installation Qualification Operational Qualification
Verify that the equipment is Confirm that the equipment
installed correctly and meets functions as intended and meets
specifications. performance criteria.

3
Performance Qualification
Validate that the equipment
consistently produces accurate and
reliable results.
Ongoing Maintenance and
Change Control
Preventive Maintenance
Regularly maintain the system to prevent failures and
ensure optimal performance.

Change Control
Establish a formal process for managing changes to the
system and ensuring their impact is assessed and
validated.

Periodic Revalidation
Conduct regular revalidation activities to ensure continued
compliance and system integrity.
Conclusion and Key
Takeaways
Computerized System Validation is a crucial aspect of maintaining
the integrity and reliability of computerized systems in regulated
industries.

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