New to validating computerized systems? If so, it might be difficult to get started on this type of validation. Why? Because, even if you have experience in another area of validation, you will have to deal with new, unfamiliar terms. After all, it’s a very technology-related topic. In this article, you will learn what GAMP is, what GAMP categories are for, and where to start if you are facing computerized systems validation.
Curious? Be sure to read on!
What is GAMP?
In a nutshell, GAMP is the acronym used to summarize the term “Good Automated Manufacturing Practices“. These are a compilation of recommendations published by the International Society for Pharmaceutical Engineering (ISPE) in the form of a book to provide guidance on the compliance of computerized systems in regulated industries.
What are GAMP (5) categories for?
GAMP categories are mainly used to subdivide computerized systems according to their complexity. In this way, the validation strategy can be focused on the points where the system is riskier.
The more complex a system is, the greater its risks will be. These risks primarily involve data integrity, product quality, and patient safety.
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GAMP categories for computerized systems
In this whitepaper, you will learn what GAMP is and where to start if you are facing computerized systems validation.
GAMP 5 software categories with examples
There are 4 categories in which GAMP 5 groups computerized systems according to their complexity. These categories define the approach to full validation. In other words, they determine:
- the validation route to follow
- and the necessary documents to demonstrate that your system is suitable for the use that will be given and complies with the GxP regulation.
GAMP category 1: infrastructure
GAMP category 1 description
GAMP category 1 examples
Infrastructure.
Platforms on which computer applications or elements are necessary to operate and manage information technology environments run.
Operating systems, firewall, antivirus.
GAMP category 3: non-configurable software
GAMP category 3 description
GAMP category 3 examples
Non-configurable software. Software without configurable functions, they are marketed freely or are integrated into hardware to allow their operation.
As examples, there are tools for statistical calculation, software for data acquisition without configuration capacity, control panel viewers, spreadsheets used as databases or as documents without some level of configuration.
GAMP category 4: configurable software
GAMP category 4 description
GAMP category 4 examples
Configurable software.
They allow you to run a specific business process. These configurations include, but are not limited to, operating, measurement, control parameters, and may use other external interfaces to complete the function.
GAMP category 5: custom or bespoke software
GAMP category 5 description
GAMP category 5 examples
Custom or bespoke software.
They are those that are tailored to meet specific needs of the organization that optimize its processes.
What is considered a configuration?
The configuration of a computerized system refers to the values ​​that are assigned to a certain variable of specific software, which do not imply changes or modifications of the original functionalities, but rather indicate how the system should work to adapt to the needs of the users in the context of their processes.
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GAMP categories for computerized systems
In this whitepaper, you will learn what GAMP is and where to start if you are facing computerized systems validation.
Why is there no GAMP category 2?
GAMP category 2 is currently in disuse because, when the categories were defined in version 4 of GAMP, firmware had its own characteristics that differed from the rest of the categories.
Nowadays, firmware has evolved to the point the majority is counted as category 3, 4, or 5. So, when GAMP 4 transitioned to GAMP 5, category 2 was removed but the numbering was not changed, leaving only categories 1, 3, 4, and 5.
Conclusion
GAMP categories are useful for classifying systems according to their level of complexity to determine a validation strategy that can meet the requirements, but more importantly, to focus on the issues that pose a significant risk to the functionality of the systems.
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