Ultimately, GAMP is the bridge between the speed of software and the safety of medicine. It is, quite literally, good practice. References: ISPE GAMP 5 Guide (Second Edition), FDA Guidance on Computer Software Assurance for Manufacturing and Quality System Software, ICH Q9 Quality Risk Management.
In 1991, a group of industry leaders in the UK formed the GAMP Forum. Their insight was revolutionary: . A simple temperature logger does not pose the same risk as a sterilization control system. Therefore, validation should be scaled and risk-based. gamp standards
Note: GAMP 5 dropped the old Category 2 (Firmware) as it was deemed obsolete. Ultimately, GAMP is the bridge between the speed
The key takeaway for any professional is this: gamp standards