Verification or Validation
Current Regulatory Expectations and Recent Audit "Hot Buttons”
The Project Validation Plan
Product and Process / / Facilities / Equipment Software V&V
When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
GAMP / Other Considerations
The FDA's 11 Key V&V Documentation Elements
21 CFR Part 11, QMS, Electronic Records / E-Signatures
"White Box" and "Black Box" Validations
Current Regulatory Expectations and Recent Audit "Hot Buttons”
The Project Validation Plan
Product and Process / / Facilities / Equipment Software V&V
When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
GAMP / Other Considerations
The FDA's 11 Key V&V Documentation Elements
21 CFR Part 11, QMS, Electronic Records / E-Signatures
"White Box" and "Black Box" Validations
