The "ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management" discusses how critical thinking based on product and process knowledge and quality risk management can enable the removal of barriers to the introduction of new and innovative technologies. Practical considerations are presented, such as ways to increase the maturity level of an organization’s critical thinking ability, the appropriate use of traceability tools to eliminate duplicating documentation as audit evidence, and approaches to IT/IS service provider assessment and governance.
The Guide provides information to support the adoption of new and improved approaches to software engineering, data management, and “as a Service” offerings (XaaS), including the use of supporting tools. This helps regulated companies facilitate the best use of resources and encourages the application of appropriate and proportionate practices.
The Guide explains the benefits offered by adopting innovative practices combined with the experience and knowledge of the Subject Matter Experts (SMEs) to identify how best to realize opportunities to provide processes, services (and products) that are fit for their intended use and can be efficiently maintained in a state of control.