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The introduction of e-signatures brings enormous benefits in the pharmaceutical industry and can significantly accelerate the digitization process in this industry.

Lack of digitization, high archiving costs and long processing times are unfortunately still often standard in the pharmaceutical industry. In a regulated environment, such as the pharmaceutical industry, everything must be documented and proven, so constant signatures are required. This applies to a high number of documents, such as applications, checklists, forms, and manufacturing or inspection records. Since the signing process is mostly manual and some processes may even have to be checked by several people, this can result not only in long processing times, but also in immense paper consumption and costs.

Long archiving periods apply in the pharmaceutical industry, so all documents must be systematically organized so that they can be quickly retrieved in problem cases. However, with the high volume of printed and signed documents, so many quickly accumulate that extra storage halls have to be rented for them and employees hired to manage them.

With advancing digitalization, the topic of “data integrity” in particular is increasingly becoming the focus of pharmaceutical companies and monitoring authorities. The question of how robustly data is recorded, i.e. to what extent the data is correct, complete and consistent, and whether the applicable security requirements have been taken into account, is of particular importance in the GxP environment. With SIGN8, all these requirements can be met. Thus, the e-signature solution is perfectly suited to progressively digitize the pharmaceutical industry.

The advantages of digitizing these complex signature and storage processes in the pharmaceutical environment are obvious: in addition to a high degree of flexibility in everyday work, time and costs can be saved considerably by using digital archiving. A long search in old files is therefore a thing of the past, as you can easily search for the document in question using various functions, such as the filter function. Likewise, the susceptibility to errors and the risk of losing the protocol over time can be significantly reduced. However, the complete digital implementation of these processes is unfortunately much more difficult in reality.

SIGN8 is a suitable technology for ensuring compliance in digital form as well and for legally signing documents. There is still some way to go before the entire work process in the pharmaceutical industry can be carried out via a digital tool, but digital technical solutions such as SIGN8 already offer a great deal of added value for the still manual signature and approval processes in the pharmaceutical industry.

SIGN8 can also be used to advantage in the Healthcare sector in general.


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