FDA Compliance: Go West!

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.