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IT Validation – the Direct Way to Compliance

20.07.2012 -

There is rarely a topic which polarizes experts more than the validation of IT-systems. Some would even comprehensively validate systems which only have a remote influence on product quality while others undervalue the meaning of obviously critical systems. A huge uncertainty can be observed everywhere as well as constant competition between too much and too little until the point of a complete and an escape to the good old world of paper.

The reasons for the uncertainty are manifold. They range from the basically abstract character of this topic through an increasing distribution of data and applications (catchword cloud) to a hindered access for people who are not familiar with IT; due to a technical language overload with English expressions and acronyms. Also, the general pressure on cost does not stop at IT-validation. Times in which IT-systems were analyzed down to their last bit belong to the past.

When facing these problems and looking for help from manufacturers and distributors one will often be disappointed Because even Software manufacturers who advertise with industry specific know-how, often have little knowledge of the execution of validation projects.

The key to handle all these problems and to avoid IT-validation projects engulfing resources lies in three basic characteristics of which there is a lack of in the majority of projects: pragmatism, comprehensibility and transparency.

A pragmatic approach to IT-validation projects means focusing all activities on to the two overriding aims: "product quality" and "patient safety". These are clearly defined under GMP. This can only be achieved through a strictly risk-based approach in which the basis of all validation activities is a documented risk assessment. From system overall validation master planning down to system specific single functions the validation effort can thereby be focused on the really critical IT-processes.

The (correct and above-all controlled) integration of manufacturers and distributors is essential in a pragmatic approach. This should already be defined during supplier selection in the validation planning phase. Basically: the more technical knowledge is needed in certain validation activities; the more worth doing supplier integration is.

The second essential characteristic is comprehensibility. The important interdisciplinary cooperation between process owner, IT-expert and quality assurance can only be managed with a mutual understanding of the required content.

The third and last component for a successfully and efficiently conducted IT-validation project is transparency. This really is a question of project culture and the willingness to break down complex problems to calculable working packages. Finally, every single step of the whole course of the project has to be justified, based either on regulatory guidelines, on Good Practices or on specific risk assessments.

But how can this be ensured - the pragmatic, comprehensive and transparent approach to IT-validation projects - and done in a simple way?

At this point an independent, external IT-validation expert comes in. Knowledge of processes, regulations, IT-expertise and quality assurance are combined in this one person. His experience and neutral view represents the perfect moderator in risk analysis. Furthermore, he helps to keep the focus on the essentials during the whole validation process. He forms the perfect interface in an interdisciplinary validation team and contributes to a consistent comprehensibility of complex and abstract issues.

With a transparent project culture, the external IT-validation expert is the right partner on the direct way to GMP-compliant IT-systems.


gempex GmbH – THE GMP-EXPERT

Besselstraße 6
68219 Mannheim

+49 621 819119 0
+49 621 819119 40