In 21 CFR Compliance element eleven, the meals and Drug administration (FDA) establishes its requirements for electronic records and signatures. Those guidelines, which apply to all FDA application regions, have
Part 11, Electronic Records; Electronic Signatures – Scope and ApplicationPart 11, Electronic Records; Electronic Signatures – Scope and Application
I. INTRODUCTION This guidance is intended to describe the Food and Drug Administration’s( FDA’s) current thinking regarding the compass and operation of part 11 of Title 21 of the law
FDA 21 CFR Part 11 And Compliance For FTIRFDA 21 CFR Part 11 And Compliance For FTIR
FDA 21 CFR Part 11 In the 1990’s, in order to promote a reduction in the quantum of paper used for attestation, the FDA( Food and Drug Administration, USA) established