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Pharmaceutical Manufacturing and Packing Sourcer

Secure Systems

Quality and safety in drug manufacturing are overriding concerns. Regulators are now tightening their grip on the integrity of all produced data. In the pharmaceutical industry, standards require close monitoring of drug development and logistics to guarantee their quality, safety and efficacy, which results in numerous differing measurements that produce an ever-growing amount of data. This information has to be kept safe, available and traceable. However, until now, the guidance provided by regulators has not focused on data integrity, thus inherent problems with data collection and storage are not being addressed.

Targeting Data Integrity

Regulators have found gaps between industry practice and existing technology. Many companies have misinterpreted earlier guidance or do not know how to apply its demands to their systems. As a result, they do not achieve sufficient data integrity.

Publication of Good Manufacturing Practice (GMP) non-compliance reports, warning letters, import alerts and notices have clarified that regulators are targeting honest information failures in their current inspections. Subsequent enforcement actions have led to supply withdrawals, product recalls and consent decrees across multiple markets. They have also damaged the reputation of the companies involved to a varying degree. With regulators increasingly targeting integrity, understanding correct data management practices is crucial.

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Piritta Maunu is an Industrial Measurement Expert at Vaisala, with many years of experience in biotechnology. She has worked in quality management, R&D and GMP production. Piritta holds an MSc in cell biology and is an instructor of general biology. As a manufacturer of environmental measurement and monitoring systems, Vaisala is invested in understanding the relationship between computerised systems, network functionality, device capabilities and data integrity. Over the past decade, Vaisala has continuously developed its viewLinc monitoring system software, which strives to ensure data integrity. 
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Piritta Maunu
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