Before being launched onto the market, cosmetics and medicines have to undergo extensive controls and tests. Thanks to DocuSign, a cosmetics manufacturer now has a binding, officially recognized solution for valid digital signatures. These are legally binding and forgeries are not possible. The fact that DocuSign is technically easy to integrate into the existing document management process leads to a signature and approval process without any media disruption.
Processes and approvals are not only easier to archive and retrieve, but have also become significantly quicker compared to the pre-existing IT-based solution. This ultimately leads to a faster approval process and reduces the time to market for products destined for the US market.
DocuSign proved itself as the perfect solution here. Not only was it able to be introduced quickly, but it also created a binding legal basis for the digital signature process.
The development, production and distribution of cosmetics and medicines are subject to strict requirements. All manufacturers wishing to offer such products on the US market require approval from the FDA (Food and Drug Administration) . Even though the standards required for cosmetics are significantly lower than those for pharmaceuticals, cosmetics must still meet certain FDCA requirements (Federal Food, Drug and Cosmetics Act). So cosmetics manufacturers and distributors are also subject to limited state supervision. Within this context, companies must prove to the FDA that they take responsibility for their products. An established acceptance and approval process with clear regulations ensures this. This process links the producing company with the FDA. In the course of modernizing document management for a European cosmetics manufacturer, the question arose of how to digitally handle the approval process. T-Systems solved this challenge with the help of DocuSign.
An internationally active cosmetics manufacturer produces an abundance of documents. Many of these are essential for documenting the production process and for quality control. And these in turn are hugely relevant to product approval. Together with T-Systems, the company is therefore implementing the ImageMaster document management system (DMS).
This not only stores the documents, but also supports workflows, such as approvals, for example. To this end, the option has been integrated to also include the signatures of responsible staff in various processes and sub-processes. ImageMaster's functionalities are sufficient even for complex internal processes. For official communication with regulatory authorities, however, the cosmetics manufacturer needs a solution that also makes legally binding signatures possible.
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The company has chosen DocuSign, which is able to provide certified digital signatures. There are 500,000 companies already using the solution to conclude contracts in a legally secure way. DocuSign is a web service with high levels of availability, provided from a European data center. T-Systems integrated the service with the ImageMaster workflows via DocuSign's API offering.
In this way, internal processes can be extended elegantly beyond the company's boundaries to reach reliable, auditable agreements with the FDA. Implementing DocuSign took just under four weeks. The development period for templates that map the signature processes and the roles involved also took place within this timeframe.