GAMP 4 popularized the V-Model for computerized system validation. It gave industry a common language—User Requirements (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ. For the first time, auditors and suppliers could agree on what "done" looked like.
If your company is still strictly following GAMP 4, you are likely over-validating, spending too much money, and delaying time-to-market. It is time to upgrade your quality mindset to GAMP 5's "critical thinking" approach. GAMP 4 popularized the V-Model for computerized system
(Good Automated Manufacturing Practice) was a set of guidelines published by ISPE (International Society for Pharmaceutical Engineering) designed to ensure that pharmaceutical manufacturing systems are fit for their intended use. Functional Specifications (FS)
Ongoing processes ensure that any changes are formally reviewed so the system remains in a "state of control". Design Specifications (DS)