diCELLa Compliance

Since its beginnings in the market of research software companies, diCELLa unlimited has attributed extraordinary importance to the security of the medical data of patients who participate in the clinical study.

Every day while designing software and operating research, we ensure your confidential medical data is safe. Each of our employees - developers and customer service representatives - has completed training on GCP. Therefore, we are confident that their knowledge is up-to-date. Our team is constantly improving its qualifications through numerous trainings on data security and protection. We make sure that they follow all the procedures implemented in our company.

diCELLa unlimited operates by ISO 9001 and 27001 standards granted in November 2023. While acting internationally, we also follow U.S. FDA requirements, 21 CFR (Part 11) and HIPAA. We guide our workload on the principles written into these documents to ensure the security of our customers' data.

In addition, our work practices comply with standards and guidelines, such as the ICH GCP (E6), the 2022 renewed ISPE GAMP5 guideline (specifically CSV), and EU GMP Annex 11 ("computerized systems").

Day after day, we have been working and regularly implementing security solutions and features that we test and improve to ensure that all the data is safe because patients are all that matters!

Compliant with ISO Standards - details

We are proud to announce that our company has been granted certification for the ISO 9001 and ISO 27001 standards
ISO 9001

ISO 9001:2015 Design, production, sales and after-sales support of software for the medical industry of clinical research.

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ISO 27001

ISO 27001:2013 Information security management in the field of design, production, sales and after-sales support of software for additional equipment in accordance with SoA of October 1, 2023.

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