Process Control Systems GAMP 5 Software Categories

In the article Validation Determination the use of categorising software was discussed and how this can support the approach to the validation. In this post we are looking at types of software which fall in to these categories for Process Control Systems / Automation Systems.

Categorising software is used to support the approach to the validation based on complexity and novelty of the

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CSV Periodic Review

Regulatory requirement
Both the FDA and EU GMP’s detail the requirement for demonstrating that a computer system remains in a validated state throughout its operating history.

FDA 21 CFR 211.68(b) States:
“Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based

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Spreadsheet Validation

Spreadsheets have become commonly used within a wide range of applications within the pharmaceutical and biotechnology industries. These range from the management of documentation lists through to complex algorithms used to support batch release.

This post provides a description of a risk based approach to the validation of spreadsheets. As with all posts comments are welcome.
The approach to

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What is a risk based approach?

As discussed in a previous article (Changes in Validation) a risk based approach to computer systems validation has change the way validation is performed.

Spend LessMany in the pharmaceutical and biotech industries miss understood the message of a Risk Based Approach as an opportunity to take quality risk and spend less on the introduction of new equipment; that is to take a risk.

However this

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Efficient Software Testing

Testing, as with all validation activities, is not only performed to demonstrate regulatory compliance but to ensure that the system operates correctly.

The level of testing performed should be dependant on the complexity, maturity and criticality of the system.

A standard laboratory instrument should not need the same level of testing as a bespoke automated control system. This is where the

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GAMP5 Software Categories

As discussed in ISPE GAMP 5 the GAMP Categories for hardware and software have been retained in GAMP 5, all be it in a modified format from GAMP4.

The software categories identified in GAMP 5 do not fit with determining the risk to product quality, efficacy or data integrity and no longer plays an integral part to determining that a computer system is fit for purpose.

The complexity and the

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Changes in validation

There have been many changes to the approach to validation of equipment, including computerised systems over the last few years. This has culminated in the release of GAMP 5 in 2008.

The changes in approach started with the publication of the ICH Q9 (Quality Risk Management) in 2005 and adopted by the major agencies. This presented a risk based approach to quality management including validation

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