GAMP5 2nd Edition and CSA (Computer Software Assurance) GAMP – Good Automated Manufacturing Practices was founded in 1991 and is a trademark of the International
Electronic Records and Electronic Signatures (ERES) The 21 CFR Part 11 Regulation Electronic Records and Electronic Signatures are utilised in Pharmaceutical and Medical Device industries
WHY CRITICAL THINKING IS ESSENTIAL TO YOUR DATA INTEGRITY STRATEGY What is Critical Thinking? Critical thinking is a method of objectively analyzing the data on
COMPUTER SOFTWARE ASSURANCE (CSA) IN ACTION A Risk Based Approach Preparing and testing documentation on average takes 80% of the time dedicated to validation. The
SHIFTING THE VALIDATION PARADIGM: From CSV to CSA. In 2011 the FDA launched their “Case for Quality”. The FDA carried out an in-depth review on
Remote Versus On-Site The 2019/2020 period has been unique for the Medical Device Industry around the world. This has led companies to seek innovative methods
Here’s What You Need To Know… What Is Process Mapping: The purpose of Process Mapping is for organisations to improve efficiency. It is the gathering
Do you need help Validating Software and Systems to meet Regulations? Have you a temporary shortfall in testers or qualified Validation Engineers to manage current
What is Critical Thinking? Critical thinking is a method of objectively analyzing the data on any problem, subject or content in order to form a
Integrity in the Data LifeCycle If you are working with data in a Life Sciences organisation it is imperative that you can guarantee its integrity