How Technology Has Changed Regulatory Compliance in the Past Decade.
We live in a time of rapid change and information overload. It helps to pause and ponder the state of things once in a while. In the software industry, the Agile principles call for regular evaluation to sustain constant development work. In the quality field, the concept of continuous improvement is embedded in the Quality Management System (QMS) as a never-ending cycle of changes based on reviews and audits.
This book will explore how the use of technology in the past decade or so has helped both regulated companies and regulatory agencies in easing the pains of delivering those products to patients and consumers worldwide. Regulatory milestones enforced by the FDA helped define the book’s scope.