Product labelling
Labelling in the Context of Validation
Besides the already complex processes involved in the production of medical devices, diagnostic products, pharmaceuticals and medical supplies, producers of medical and diagnostic technology and pharmaceutical companies confront the challenge of ensuring that all the (product) labels and package inserts they produce conform to legal requirements; they then have to deliver these via a multitude of distribution channels. In addition, extensive demands are placed on the companies’ IT systems designed to handle these needs, as well as on the processes mapped by the systems. Both must be designed to be compliant with guidelines and standards.
adesso provides support to companies introducing or optimising their respective labelling management systems or integrated archiving and enterprise content management solutions (ECM), as well as assisting them to conceptualise and then implement professionally and technically suitable workflows; the basis of this support is comprehensive industry know-how. In line with the prevalent good manufacturing practice (GMP) guidelines – above all those concerning the Annex 11 standard – adesso focuses on a CSV compatible generation of all relevant labelling and documentation and advises those handling computer-assisted validation processes.
Would you like to learn more about our expertise in the area of product labelling? Please feel free to contact us.
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adesso Services for the Healthcare Sector
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