Validation Center

Computer System Validation News

Are your procedures aligned with the FDA Guidance for Analytical Procedures and Methods Validation?
August 07, 2015

Last month, the FDA published this document for drug and biological license applicants submitting analytical procedures ...

Are you ready for the new version of ICH E6 Good Clinical Practice for Electronic Records?
July 16, 2010

R2 of E6 Good Clinical Practice has been published for consultation. Once approved, it will replace the original R1 vers...