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Computerised System Validation
Master scope, lifecycle, and regulatory requirements
60 hours (11 modules)
Professional Certification
About This Course
Comprehensive online training on computerised system validation covering GxP determination, GAMP categories, validation lifecycle, risk assessment, and regulatory compliance with industry-recognized certification.
Ideal For:
- Quality Assurance professionals
- Validation Engineers
- System Administrators
- Compliance Officers
- Regulatory Affairs specialists
- Project Managers in regulated industries
Enrollment Options
This Course Covers
GAMP 521 CFR Part 11Annex 11Data IntegrityER/ES Requirements
What You'll Learn
Understand CSV scope, boundaries, and interfaces
Apply the seven determinations framework
Classify systems using GAMP 5 categories
Design qualification protocols
Conduct installation and operational qualification
Perform performance qualification
Build traceability matrices
Prepare validation documentation
Meet regulatory requirements (FDA, EMA, Annex 11)
Obtain professional certification
Course Structure
1
Before Anything Is Validated
Scope, determinations, ownership
2
The Assessment
Seven determinations explained
3
User Requirements
Defining what the system must do
4
Risk Management
Risk assessment frameworks
5
Functional Specification
System behavior and logic
6
Design Qualification
Design phase validation
7
Installation Qualification
Installation phase validation
8
Operational Qualification
System operation validation
9
Performance Qualification
Performance under real conditions
10
Traceability
Requirements tracing and audit trails
11
Final Exam & Certification
Assessment and certificate issuance
Key Features
Expert-led content from specialists in NABL Traceable calibration
Progressive modules with sequential unlocking
Server-graded exams with detailed feedback
Professional numbered certificates (RNC-CSV-2026-XXXX)
Lifetime access to course materials
Optional one-to-one coaching available
Support via calibration@ranucal.in
Ready to Master CSV?
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