GAMP5 Insights

What is GAMP5?

GAMP 5 (Good Automated Manufacturing Practice) is a guideline for computer system validation (CSV) in the pharmaceutical and other regulated industries. It provides a risk-based approach to validating automated systems to ensure they are fit for their intended purpose and comply with regulations. It covers the entire lifecycle of an automated system, from planning and specification to operation and decommissioning, and promotes a common understanding of computer system validation among manufacturers and regulators.

Find organizations using GAMP5 on Sumble →

What other technologies are related to GAMP5?

GAMP5 Competitor Technologies

Kneat

Kneat is a validation lifecycle management platform that can be used as an alternative to the GAMP5 methodology.

mentioned alongside GAMP5 in 8% (78) of relevant job posts

GAMP5 Complementary Technologies

21 CFR Part 11

21 CFR Part 11 is a regulation regarding electronic records and signatures, and GAMP5 provides guidance on how to comply with it.

mentioned alongside GAMP5 in 15% (385) of relevant job posts

ASTM E2500

ASTM E2500 is a standard for verification, and GAMP5 is a methodology for validation. Both aim to ensure the reliability of pharmaceutical manufacturing systems.

What is GAMP5?

What other technologies are related to GAMP5?

GAMP5 Competitor Technologies

GAMP5 Complementary Technologies

Which job functions mention GAMP5?

Which organizations are mentioning GAMP5?