06.23.20 -- Data Integrity In A Cloud-Based World: Regulations & Best Practices

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Introduction To Science- And Risk-Based Cleaning Validation Using ASTM E3106 & E3219
		By Andrew Walsh, Thomas Altmann, Joel Bercu, Ph.D., Alfredo Canhoto, Ph.D., David G. Dolan Ph.D., Andreas Flueckiger, M.D., Igor Gorsky, Jessica Graham, Ph.D., Ester Lovsin Barle, Ph.D., Ovais Mohammad, Mariann Neverovitch, and Osamu Shirokizawa This article discusses some of the history that began the movement from compliance-based approaches to cleaning validation to the science- and risk-based approaches introduced in the American Society for Testing and Materials (ASTM) E3106 Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation and the ASTM E3219 Standard Guide for Derivation of Health Based Exposure Limits (HBELs).

Data Integrity In A Cloud-Based World: Regulations & Best Practices
		By Kip Wolf, Tunnell Consulting, @KipWolf There was a time when cloud computing was thought of skeptically by the life sciences community, through both the critical observations that are typical of science-based industry and the ingrained cultural resistance to change that comes along with a heavily regulated environment. But today, cloud solutions are ubiquitous in the industry.