This training course on Computer System Validation covers a risk-based approach in Computerized System Validation (CSV). The course provides an overview of GAMP5 guidelines, Validation Deliverables, Annex 11, ALCOA +, and the CFR Part 11.
Software testing courses offered at QCLYNX cover the entire testing domain which includes automation and manual testing, and they are all in line with standard industry certifications. Software testing is crucial to any organization, and it's important to make sure the software application runs smoothly without any issues. This testing course provides all testing techniques, documentation needed, Software Testing Life Cycle, Defects life cycle, and different types of tests performed for effective and efficient delivery of quality products
Have a thorough understanding of the Validation & it’s application to computer systems intended use.
Be able to use GAMP5 Risk based approach
Understand the major life cycle of computerized systems
Understand software categorization and the validation efforts required for various computerized systems based on category
Understand computerized system validation from a regulator’s perspective. Data integrity issues under control
Understand CFR Part 11 compliance and Annex 11 for CSV
Understand Good Documentation Practices
Learn how to write to effective qualification scripts
TOPIC 1 : BASICS OF VALIDATION
TOPIC 2 : GAMP 5
TOPIC 3: RISK ASSESSMENT
TOPIC 4: 21 CFR Part 11
TOPIC 5: MAINTENANCE PHASE
TOPIC 6: CLOUD COMPUTING
TOPIC 7: DATA INTEGRITY
TOPIC 8: VENDOR ASSESSMENT
TOPIC 9: TESTING OF COMPUTER SYSTEMS
TOPIC 10: GOOD DOCUMENTATION PRACTICES
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