Validation Center
Computer System Validation News
Are you ready for the FDA guidance on Data Integrity and Compliance?
September 23, 2024The FDA just published a new, draft guidance document on good manufacturing practices (cGMP) for drugs. This document is...
Are Active Pharmaceutical Ingredient Manufacturers Compliant With New FDA GMP Guidance?
December 10, 2016In September, the FDA published Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients to provide AP...
Are you complying with the European Commission's new version of Annex 16?
November 23, 2015In October, a new version of Annex 16 was published due to significant changes in the globalization of pharmaceutical su...
Are you prepared for WHO draft guidance on Good Data and Record Management Practices?
October 05, 2015In September 2015, the World Health Organization (WHO) published a draft guidance document focused solely on data integr...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 ...