The author discusses the collection and evaluation of data part of FDA’s definition of process validation. Process validation is more than just running three consecutive batches under manufacturing ...
Audit. Compliance. Team training. Process re-engineering. Every one of these activities requires that your team have accurate business process documentation in-hand to maximize success. Is it optional ...
Editor’s note: This article is the third in a series to help practitioners learn about the AICPA’s new quality management standards and prepare to implement them. The new final standards on quality ...