#GAMP CATEGORIES EXAMPLES SOFTWARE#

This is widely available software that can be used by anyone and in any industry. The least risky and most widely available software is in category 1 (operating systems, databases, office software, and other widely available software). If you look at Table I there is a built-in risk assessment. What benefit does this software classification provide? Refer to Table I as we discuss the changes in the software classification in more detail in the next section.īefore we go into a detailed discussion of the software categories, perhaps we should ask the question 'Why bother to classify software?'. So we now have the following four categories: This is a natural evolution of this approach to software classification. To help resolve this debate, in GAMP 5 the software categories have been revised and refined - most for the better and one for the worse. The constituents of each category are outlined in Table I however, there was always a debate about some commercial software packages - were they category 3 or 4? Many spectroscopists would argue that an application should be classified as category 3 and not 4, as it should be less work to validate and evade the real classification. In the beginning, or at least in GAMP 4, there were five categories of software: Table I: Comparison of software categories in GAMP 4 and GAMP 5

To appreciate the scope of these changes fully we need to look at the classification of software from GAMP 4 (2) and compare this with GAMP 5, as shown in Table I. Īs I mentioned earlier, the software categories in GAMP 5 have been revised (1). Note that GAMP is a guide and you can deviate from it - all that is required is the application of thought and intelligence coupled with effective risk management that is well documented. The key message is that now a single size life cycle model does not fit all systems. However in GAMP version 5, I'm very pleased to say that the 'one size fits all' approach has been replaced by a breath of fresh air with different life cycles depending on the classification of the software being implemented. However, the model does not make it into version 5 of the Guide, which is a shame as mentioned above, the model is very good for process equipment. The first version was written by a group of volunteers in the UK in the early 1990s as a mechanism to control suppliers of process equipment to the pharmaceutical industry, and this legacy survived through to version 4. The problem lay in the origins of the GAMP guide. For example, when a commercially available laboratory system was validated, functional and design specifications were written for virtually no gain but at a great cost in time and resources. Therefore, every validation was shoehorned into an inappropriate model because there was little thought and intelligence applied and the model followed blindly. It had very little to do with computerized systems, especially laboratory ones. My rationale for this position is that versions 1–4 of the guide presented a single life cycle V model that was really only applicable to process equipment and manufacturing systems. I love the classification of software outlined in Appendix M4 and hate the life cycle V model. However, before we continue much further I should also declare a vested interest: I have a love–hate relationship with the GAMP guide.

We will explore version 5 of the software classification and see what changes we need to make to ensure that it can be implemented practically and effectively in any laboratory. This is one of the best parts of the guide as it has an in-built risk assessment, as we shall see in this column. This publication has been available since 1994, when version 1 was informally published in the UK, and since its inception it has always contained a classification of software. Version 5 of the Good Automated Manufacturing Practice (GAMP) guide (1) was released last year. This column will look at what the changes mean for the laboratory and whether all of these should be implemented.

The GAMP (Good Automated Manufacturing Practice) guide version 5 was released in March 2008 and one of the changes was that the classification of software was revised again.

Gamp categories examples