Computer System Validation (CSV) Toolkit
Ready-to-use CSV toolkit for validation, QA and IT professionals and job candidates. It has 3 fillable PDFs to plan a risk-based validation, trace requirements to tests and evidence, and practise 60 interview questions aligned with 21 CFR Part 11, EU GMP Annex 11, GAMP 5 and FDA CSA.
What you’ll get
- 3 fillable PDF resources
- 6 validation planning worksheets, from scope to plan
- GxP impact and risk-classification templates
- Traceability matrix with column guide and worked example
- Electronic records and signatures checklist
- 60 CSV interview questions with key answer points
- 12 common mistakes and 3 practical scenarios
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