FDA

FDA Compliance: Go West!

MOXIS is FDA-compliant and perfectly suited for all food and pharmaceutical companies whose trading partners are based in the United States.

The U.S. Food and Drug Administration (FDA) is the food and drug regulatory agency of the United States. It reports to the Department of Health and Human Services. Its task is to protect public health. This means that the FDA’s regulations are very strict – even when it comes to digital signatures. The food and pharmaceutical industry is required to act in close coordination with the FDA.

According to the FDA, Title 21 of the Code of Federal Regulations (CFR) Part 11 sets out the requirements for digital signatures and must be applied whenever paper-based signatures are replaced by digital ones. It specifies in detail the requirements that companies must fulfil when using digital signatures. MOXIS, the enterprise tool for professional signature processes, is customised to meet all of these requirements. This makes MOXIS FDA-compliant and perfectly suited for all food and pharmaceutical companies whose trading partners are based in the United States.

MOXIS fulfils all of the FDA’s requirements. As you can see below, the FDA requirements set out in Title 21 CFR Part 11 only represent a small part of the entire MOXIS range of services: 1. The authority validates the authenticity, integrity and confidentiality of documents to ensure accuracy, and reliability so that invalid or altered records can be recognised. 2. Protecting records so that they can be retrieved accurately and easily throughout the retention period 3. Restricting system access to authorised persons. Verifying that individuals who develop, maintain or use electronic recordkeeping/signature systems have the education, training and experience to perform their assigned tasks. 4. A digital signature must contain the following information in a format that is legible to humans: (1) Name of the person signing (2) The date and time of the signature (3) The reason for the signature 5. Digital 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 digital signature must be unique to an individual and may not be reused or reassigned to another individual. 7. Before a digital signature is issued, the person signing 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 their signature.
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Are you looking to organise the signature processes in your company efficiently and without media disruption, and save time and money in the process? The MOXIS electronic signature folder is your companion on the way there – numerous well-known customers are already working successfully with the enterprise solution for digital signatures. Request a free, no-obligation live demo with our experts now!

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