Computer System Validation (CSV)
Computer System Validation (CSV) in the pharmaceutical industry is a critical process to ensure the reliability and accuracy of computerized systems used in drug development and manufacturing. It involves a series of activities to confirm that these systems meet predefined specifications and fulfill their intended purpose. CSV helps to maintain data integrity, protect patient safety, and comply with regulatory requirements.
Installation Qualification (IQ)
In Computer System Validation (CSV) in the pharmaceutical industry, Installation Qualification (IQ) is the initial phase of verifying that a computer system is properly installed and configured. IQ focuses on ensuring that the hardware and software components are received as specified by the manufacturer, installed correctly in the designated environment, and that all necessary utilities and environmental conditions are met. This involves checking for the presence of all components, verifying serial numbers, and ensuring proper connections and cabling. IQ establishes a baseline for subsequent validation activities, confirming that the system is ready for further testing and operational use.
Operational Qualification (OQ)
Operational Qualification (OQ) in Computer System Validation (CSV) in the pharmaceutical industry is the second phase of the validation process. OQ verifies that the computer system functions as intended according to its specifications and user requirements. This involves testing the system’s functionality, accuracy, and reliability. OQ ensures that all system parameters, alarms, and safety features operate correctly. This phase confirms that the system is capable of performing its intended tasks consistently and reliably, providing confidence that it will deliver accurate and trustworthy results.
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Table of Content
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Approval
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Purpose
Scope
Description
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References
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Responsibilities
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Definitions
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Definitions
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Execution Instructions
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Installation Qualifications
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Installation Qualifications
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Installation Qualifications
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Installation Qualifications
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Record Verification During Installation Qualifications
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Record Verification During Installation Qualifications
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Record Verification During Installation Qualifications
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Record Verification During Installation Qualifications
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Record Verification During Installation Qualifications
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Operational Qualification
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Operational Qualification
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Operational Qualification
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Record Verification During Operational Qualification
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Test Data Verification During Operational Qualification
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Test Data Verification During Operational Qualification
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Test Data Verification During Operational Qualification
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Test Data Verification During Operational Qualification
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Verification of SOP and Disaster Recovery Plan Policy
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Verification of SOP
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Computer System Validation Test Status
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Discrepancy Report
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Recommended Corrective Action Plan and Responsible Person
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Corrective Action Taken
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Recommended Corrective Action Taken within Stipulated Period
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Acceptance Criteria
Summary
Conclusion
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Abbreviations
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List of Supporting Documents
Document Revision History
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