Validation Center
Computer System Validation News
What do you need to know about the new FDA guidance on Manufacturing Site Changes?
November 16, 2015Recently, the FDA drafted this guidance document to help the medical device industry make decisions around manufacturing...
Are you prepared for WHO draft guidance on Good Data and Record Management Practices?
October 05, 2015In September 2015, the World Health Organization (WHO) published a draft guidance document focused solely on data integr...
Are your procedures aligned with the FDA Guidance for Analytical Procedures and Methods Validation?
August 07, 2015Last 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, 2010R2 of E6 Good Clinical Practice has been published for consultation. Once approved, it will replace the original R1 vers...