Software Categories from GAMP 5.

GAMP 4, Introduction. Due to the great variety of medical devices, processes, and manufacturing facilities, it is not possible to state in one document all of the specific validation elements that are applicable. However, a general application of several broad concepts can be used successfully as guidance for validation. These broad concepts provide an acceptable framework for building a comprehensive approach to software validation.

GAMP Class	Category	Validation Action
1	Operating systems	Record Version
2	Instruments and controllers	Record configeration and calibration
3	Configerable packages	Audit supplier validate any bespoke code. Apply full life-cycle requirements.
4	Systems that the code or part of the code are configurable.	Audit supplier and code, validate any bespoke configurations apply full life cycle requirements.
5	Systems utilizing custom or bespoke code which develope predicate rules information.	Audit supplier, validate all code, apply full life-cycle requirements.

The Guide for Validation of Automated Systems, has been released in December 2001 in Amsterdam. The guide aims to assist companies in the healthcare industries to achieve validated and compliant automated systems.

It provides guidance to the suppliers of those automated systems on their development and maintenance by following good practice, and assists the suppliers in producing the necessary documentation required to support validation.

The guide is a significant advance on previous versions of this widely accepted guidance on validation of automated systems. The complete document has been revisited and refined to reflect current regulatory expectations and good practice. It has been considerably enhanced and restructured, following principles and recommendations defined by the Industry Board>
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GAMP 5

GAMP 5 SOFTWARE CATEGORIES.

GAMP 5 SCOPE