A pharmaceutical process should be managed according to a series of quality assurance measures to facilitate the meeting of regulation quality requirements, and these measures are not all time under the unique responsibility of Quality Assurance personnel.

K2Pharma module for Process Quality Management is the only one software that fully covers the new standard for Pharmaceutical Quality Systems defined by International Conference for Harmonization (ICH Q10, Pharmaceutical Quality System guideline): this standard basically requires that Process should be at the center of interest, in other terms you have to assure the quality of your process, not just the quality of your procedures… and this also means that you need a full knowledge and criticality analysis of your process, sharing the responsibilities with many colleagues belonging to different company departments. K2Pharma Process Quality Management

Easy to say, but how to do it?

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