details of csv :
Basics of Computer System Validation (CSV)
especially relevant in regulated industries like pharmaceuticals and life sciences:
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What is CSV?
Computer System Validation (CSV) is the process of ensuring that a computer-based system does exactly what it is intended to do in a consistent and reproducible manner — meeting regulatory requirements such as those from FDA (21 CFR Part 11), EMA, MHRA, and others.
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Why is CSV Important?
• Ensures data integrity, patient safety, and product quality.
• Compliance with regulations from agencies like the FDA and GxP (Good Automated Manufacturing Practices).
• Prevents costly mistakes, recalls, or audits.
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Key Regulations/Guidelines:
• 21 CFR Part 11 (Electronic Records/Electronic Signatures)
• Annex 11 (EU Guidelines)
• GAMP 5 (Good Automated Manufacturing Practice – Risk-based approach)
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Phases of CSV:
1. Planning Phase
• Validation Plan (VMP or VP)
• Risk Assessment
• System Inventory and Classification
2. Requirements Phase
• User Requirements Specification (URS)
• Functional Requirements Specification (FRS)
• Design Specification (DS)
3. Testing Phase
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
4. Reporting & Maintenance Phase
• Validation Summary Report (VSR)
• Periodic Review
• Change Control
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Common Documents in CSV:
• Validation Plan (VP)
• URS, FRS, DS
• Test Scripts: IQ, OQ, PQ
• Traceability Matrix (TM)
• Validation Summary Report (VSR)
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Key Concepts:
• GxP Systems: Systems that impact product quality or patient safety.
• Risk-Based Approach: Focus more validation effort on higher-risk systems/functions.
• Audit Trail: Track all changes to data or configurations.
• Part 11 Compliance: Controls over electronic records and signatures.
1. Validation Plan (VP / VMP)
Purpose:
Defines the scope, strategy, responsibilities, deliverables, and schedule for validation activities.
Includes:
• List of systems to be validated
• Roles and responsibilities
• Risk assessment strategy
• Reference to SOPs
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2. User Requirements Specification (URS)
Purpose:
Captures what the user expects the system to do — functional, regulatory, and business needs.
Interview Tip: Always trace each requirement back to a test case in the Traceability Matrix.
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3. Functional Requirements Specification (FRS)
Purpose:
Details how each user requirement will be functionally met by the system.
Includes:
• Input/output requirements
• Business rules
• Error handling
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4. Design Specification (DS or DDS)
Purpose:
Describes the technical design — how the system will be built or configured to meet the FRS.
Includes:
• Architecture
• Database design
• Interfaces and integrations