Computerized System Validation (CSV) PPT

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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
COMPUTERISED SYSTEM
VALIDATION
Presented by
M.CHARITHA
(24L81S0704)
Under the Guidance of
K.Vinod Kumar M. Pharm ,PhD
Head of the department
Department of Pharmaceutical Analysis

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• Introduction
• Objectives of CSV
• Key Regulatory Guidelines
• CSV Lifestyle
• Common CSV Documentation
• Challenges in CSV
• Benefits of Effective CSV
• Latest Trends
• Conclusion
Contents

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Definition:
Computerized System
Validation (CSV) is the
documented process of
ensuring that a computerized
system performs its intended
purpose consistently and
reliably.
Importance:
Required by regulatory
agencies like the FDA, EMA,
and under guidelines such
as 21 CFR Part 11 and
GAMP 5.
Introduction

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 Ensure data integrity, accuracy, reliability, and security
 Maintain compliance with regulatory standards
 Minimize risks associated with automated systems
 Support audit trails, electronic signatures, and traceability.
Key Regulatory Guidelines:
- FDA 21 CFR Part 11: Electronic records & signatures
- GAMP 5: Risk-based approach
- ICH Q7, EU Annex 11, WHO TRS 1019: International
harmonization
Objectives of CSV

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1. Planning:
-Validation Plan:
A Validation Plan outlines the strategy, approach, resources, and schedule for
conducting validation activities. It ensures that systems, equipment, or processes
meet their intended purpose and perform consistently. This plan typically
includes:
• Scope of validation
• Responsibilities
• Test requirements
• Acceptance criteria
• Documentation
CSV Lifecycle

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-Risk Assessment:
Risk Assessment involves identifying, analyzing, and evaluating
potential risks that could impact product quality, safety, or compliance. It
helps prioritize validation efforts by focusing on high-risk areas. Key
components include:
• Hazard identification
• Risk analysis (likelihood & severity)
• Risk control and mitigation strategies
2. Requirements Definition:
- User Requirements Specification (URS):
• The URS defines what the end user needs the system, equipment, or
process to do. It captures:
• Intended use
• Performance criteria
• Regulatory and business requirements

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- Functional Requirements Specification (FRS):
The FRS translates the user needs into detailed functional
capabilities. It defines how the system will behave and what functions
it must perform. It includes:
• Input/output definitions
• Functional logic
• Data handling and system operations
3. System Design & Development:
-Design Specifications:
• Design Specifications define the technical details of how the system will
be built to meet the functional and user requirements. This includes:
• Hardware and software architecture
• Network design

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• Interface requirements
• Security, performance, and compliance features
-Vendor Qualification:
• Vendor Qualification is the process of evaluating and approving
suppliers or vendors to ensure they can meet quality, regulatory, and
technical standards. It involves:
• Auditing the vendor’s processes
• Reviewing past performance
• Verifying certifications and capabilities

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4. Testing & Qualification:
-Installation Qualification (IQ):
• IQ verifies that the system or equipment is installed according to
specifications and manufacturer recommendations. It includes:
• Checking hardware, software, and environmental setup
• Verifying installation procedures
• Documenting configuration and calibration
- Operational Qualification (OQ):
• OQ tests the system’s functions and operations against predefined criteria. It
ensures the system performs correctly under controlled conditions. Includes:
• Functional testing of subsystems and controls
• Alarm and error handling checks
• Verification of system responses

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-Performance Qualification (PQ):
• PQ demonstrates that the system consistently performs according to
requirements under actual operating conditions. It involves:
• Real-world use case testing
• Repeated performance trials
• End-user validation
5. Validation Report:
-Summary of Results and Compliance Status:
• The Validation Report is the final document in the validation lifecycle. It provides
a comprehensive summary of all validation activities conducted, including:
• An overview of testing phases (IQ, OQ, PQ)
• Results and deviations (if any)
• Risk mitigation measures
• Assessment of whether predefined acceptance criteria were met
• A statement of compliance with regulatory and company standards

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6. Maintenance & Review:
1. Change Control:
This refers to a systematic approach for managing
changes to a process, system, or product. The goal is to ensure that
no unnecessary changes are made, that all changes are documented,
and that services are not unnecessarily disrupted.
2. Periodic Review:
This involves scheduled reviews of procedures, processes,
or systems to ensure they remain effective, compliant, and aligned
with current standards and practices. It helps identify outdated or
inefficient components that may need updating.

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3. Re-validation (if required):
Re-validation is the process of verifying that systems or processes
continue to operate within specified limits after changes or over time. It's
required if significant changes are made or if a previous validation has expired.

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- Validation Master Plan (VMP)
- Risk Assessment Report
- Test Plans and Protocols (IQ/OQ/PQ)
- Traceability Matrix
- SOPs and Training Records
Common CSV Documentation

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- Managing complex systems
- Keeping up with evolving regulations
-Balancing risk and compliance
-Ensuring cross-functional collaboration.
Challenges in CSV

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- Reduced regulatory risk
- Enhanced product quality and safety
- Improved data integrity and decision-making
- Cost savings over the system lifecycle
Benefits of Effective CSV

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- CSV to CSA: Emphasis on critical thinking and risk-based
assurance
- Emerging Technologies: Cloud Computing, AI/ML, and
Paperless Validation tools
Latest Trends

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- CSV ensures system reliability, data integrity, and
regulatory compliance
- A structured, risk-based approach enables robust
systems and smooth audits
Conclusion

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Computerized System Validation (CSV) PPT

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