Industry Resources

Bioanalytical Method Validation Guidance for Industry

FDA
- Guidance
Canadian Forum for Analytical and Bioanalytical Sciences

CFABS
- Organization
Global CRO Council

GCC
- Organization
Society of Quality Assurance

SQA
- Organization
Guideline on bioanalytical method validation

EMA
- Guideline
Bioanalytical Method Validation and Study Sample Analysis M10

ICH
- Guideline
Part 11, Electronic Records; Electronic Signatures - Scope and Application

FDA
- Guidance
Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies

FDA
- Code of Federal Regulation