FDA Compliance: Go West!

FDA Compliance: Go West!
26 Feb 2020

How MOXIS meets the requirements of the U.S. Food and Drug Administration.

The U.S. Food and Drug Administration (FDA) is the Food and Drug Administration of the United States. It reports to the Department of Health and Human Services. Its mission is to protect public health. The regulations of the FDA are correspondingly precise – even when it comes to electronic signatures. The food and pharmaceutical industry is required to act in close coordination with the FDA.

Our MOXIS solutions for the pharmaceutical industry you can find here.

The Title 21 Code of Federal Regulations (CFR) Part 11 is decisive for the requirements for electronic signatures. This part must always be applied when the paper-based signature is replaced by the digital one. It specifies in detail what companies must pay attention to when using the electronic signature. MOXIS, the enterprise tool for professional signature processes, is adapted to all requirements. The FDA requirements stipulated in Title 21 CFR Part 11 represent only a small part of the entire range of services offered by MOXIS.

(1) The Authority shall validate the authenticity, integrity and confidentiality of documents to ensure accuracy, reliability, so that invalid or altered records can be identified.

2. Protecting records so that they can be accessed correctly and easily throughout the retention period.

3. Restricting system access for authorized persons. Ensure that persons who develop, maintain or use electronic recording/signature systems have the education, training and experience to perform their assigned tasks.

(4) An electronic signature shall contain the following information in a human readable form:
(1) Name of the signing person
(2) Date and time of signature
(3) The reason for signature

5. Electronic signatures in electronic records must be linked to the records in such a way that removal, copying or similar misuse of the signature is not possible

6. Each electronic signature must be unique to a person and may not be reused or reassigned by other persons

7. Before an electronic signature is issued, the person concerned must be identified. Electronic signatures that are not based on biometric data must use at least two different identification methods such as an identification code and a password. Only the owner should have access to his signature.


For further information please read our complete german White Paper “CFR Title 21 Part 11” on the implementation of the FDA Compliance of MOXIS


Would you also like to design the signature processes in your company efficiently and without cross-media conversion while saving time and costs? The electronic signature folder MOXIS is your companion on the way there – numerous well-known customers have already deployed successfully with the enterprise solution for electronic signing. Why not requesting a free and non-binding live demo with one of our experts!

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