VALIDATION OF COMPUTERIZED SYSTEMS

In addition to setting up quality management systems (business and IT), we take on validation tasks in part or in their entirety and thus ease your daily workload.

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Documented evidence that a system meets the previously specified process requirements reproducibly in operational use

The processes of research, development and manufacture of chemical, pharmaceutical and medical technology products have been subject to regulation for many years. The demand for the validation of computerized systems (also known as IT validation), which have a direct or indirect influence on the key parameters product quality, patient risk and data integrity, was only intensified as late as 1990s with the increasing use of computerized systems.

“Where a computerized system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process”.

(Excerpt EU-GMP Guideline, Annex 11)

In concrete terms, this means that all processes, systems and activities directly and indirectly related to product manufacture must be validated / qualified and documented in an appropriate manner. In regulated industries, information relevant to product quality is therefore part of the product. The product‘s documentation, use and availability require appropriate, validated systems.

In our project work, we ensure that clear structures, demarcations and assignments create an efficient organisational and quality management system that remains manageable at all times.