Industry 4.0 has given new impetus to the introduction of integrated IT systems also in regulated areas. These systems are subject to the regulatory requirements of good manufacturing practices (GMP) and in particular the validation of systems and Data Integrity.
Regarding the validation of the systems, the reference guideline remains version 5 of the GAMP (of 2008). This proposes the basic concepts of the software life cycle, the software categories and the risk analysis to plan and execute the systems validation activities, as required by the GMPs.
These guidelines can facilitate the introduction of Industry 4.0 systems in the Italian pharmaceutical industry, allowing them to remain at the forefront in this important sector.
To deepen the fundamental concepts of validation such as the software life cycle, the software categories (and hardware) and Risk Analysis, download the PDF document (ITA).
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