Agile Software Development in GxP Regulated Environments GAMP® Special Interest Group
User Requirements (Specification)
Successful delivery requires ensuring we build the right system that is fit for the intended use, not just ensuring we build the...
Then and Now – From Certainty to Discovery Mindsets
Advancement in technologies have forced organisations to rethink business models. Organisations that were once controlled and orderly are now more chaotic and complex, serving patients and customers...
There is sometimes a perception that computer systems validation requires a V-Model approach using a waterfall methodology. This means all requirements must be agreed before design can progress and in turn all design must be signed off before the system...
Online Live Overview This Virtual course includes the new revised EU GMP Annex 11, and an update on 21 CFR Part 11. This two-day fundamental course* introduces participants to regulatory requirements for computerized...
Online Live Overview This highly interactive virtual course describes how the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems, and GAMP® RDI Good Practice Guide: Data Integrity -...
In the previous blog, GAMP® Support for Pragramtic Quality & Risk-Based Approaches, we saw how as part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) are promoting a risk-based, product quality and...
This webinar provides an overview of new and forthcoming ISPE GAMP® Data Integrity guidance and real-world experiences on applying data integrity in the field. The speakers will address the following topics: Overview of...
This webinar will discuss the lifecycle of computerized laboratory equipment, with some discussion of the similarities and differences to computer system validation, and the use of quality risk management to right-size...
Background
As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting...
The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management...
