GAMP

CFN People have together with customers in the healthcare industry worked with GAMP to ensure that ITIL® processes could be used together with the GAMP framework – thus ensuring the compliance.

Good Automated Manufacturing Practice (GAMP) aims to achieve validated and compliant automated systems meeting all current healthcare regulatory expectations, by building upon existing good practice in an efficient and effective manner.

GAMP covers all the current healthcare requirements for automated system validation and compliances.

GAMP is a common technically sound approach to validation of automated systems that is understood by suppliers and by regulators. Some of the benefits from using the GAMP principles are:

Introducing a common language and terminology
Reduce cost and time taken to achieve compliant systems
Improve compliance with regulatory expectation
Eliminate the need for expensive and time-consuming retrospective validation
Clarify the division of responsibility between user and supplier.