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Digital signatures according to FDA (Part 11) create traceability in FDA-regulated industries

Vanessa Frühbeiss
Updated on 01.04.2024

The Food and Drug Administration (FDA) plays a central role in the US healthcare system and oversees a wide range of products, from food to medical devices. This regulation serves to protect public health and safety. This article provides an insight into the FDA's responsibilities and explains the importance of digital signatures in FDA-compliant companies later in the article.

What is the FDA?

As part of the U.S. Department of Health and Human Services , the FDA was established to ensure the safety and effectiveness of food, drugs and other products. The FDA actively regulates the marketplace to protect consumers from health risks by setting standards, conducting inspections, regulating the marketing of these products, and playing a key role in the evaluation and approval of new products. It also inspects production facilities and enforces laws on food and drug safety. Its comprehensive guidelines and standards form the basis of consumer protection.

Responsibilities of the FDA

The FDA has a wide range of responsibilities, from the preventive monitoring of food safety to the evaluation of drugs and medical devices. It works closely with manufacturers, researchers and other authorities to ensure consumer safety. Its tasks include approving clinical trials and monitoring manufacturing practices to ensure consistent product quality. The integration of digital technologies, such as the implementation of digital signatures, helps to make regulatory processes more efficient and ensure the integrity of data.

Industries under FDA supervision

The FDA regulates several key industries that have a direct impact on health and safety:

  • Food industry: monitoring the safety and quality of food, beverages and dietary supplements.

  • Pharmaceutical industry: regulating the development, manufacture and marketing of prescription and over-the-counter drugs.

  • Medical devices: Monitoring of medical devices and equipment, from simple instruments to complex diagnostic equipment.

  • Biotechnology and biopharmaceuticals: Regulation of biopharmaceuticals, biological products and genetically modified organisms.

  • Cosmetics industry: monitoring the safety and labeling of cosmetics.

  • Veterinary medicines and feed: Regulation of medicines and feed for animals, including pets and livestock.

  • Tobacco products: Regulation of the marketing and sale of tobacco products.

  • Blood products and other biological products: Supervision of blood banks and transfusions.

The importance of electronic signatures in FDA-compliant industries

In regulated industries today, electronic signatures are essential to ensure compliance and traceability. FDA requirements, in particular under 21 CFR part 11, define the standards for electronic signatures to ensure the reliability and security of data. It should be noted that the eIDAS Regulation regulates electronic signatures throughout Europe. In FDA-regulated industries, however, the FDA applies, which is more stringent. These digital signatures play an essential role by offering maximum security, conformity and flexibility with regard to relevant documents, for example during product development and in the manufacturing process. In this way, the strict requirements of the FDA can be met.

What are FDA-compliant digital signatures?

FDA-compliant electronic signatures must comply with the guidelines set out in the FDA regulations in 21 CFR Part 11 . These requirements ensure the authenticity and confidentiality of electronically signed documents and contribute significantly to compliance with FDA regulations. The key elements include:

The content of a digital signature must include

  • Name of the signatory,
  • the date and time of the signature and
  • the meaning of the signature (e.g. approval, verification).

Security features:

  • Forgery protection: Ensures that the signature cannot be tampered with.

  • Link to document: Ensures that the signature is exclusively associated with the signed document.

  • Uniqueness and identification procedure: Ensures that each signature can be uniquely assigned to a person and verified using biometric or non-biometric procedures (identification code and password).

Requirements for identification codes and passwords according to the FDA

The security requirements and management of authentication data are specified in paragraphs 11.200 (a) and 11.300 and are crucial for the handling of sensitive data. Companies must adhere to the following guidelines:

Management of the authentication data by:

  • Four-eyes principle: The allocation must be regulated in such a way that an abusive attempt to use a third-party signature would require at least two people.

  • Unique combinations: The duplicate assignment of identification codes (e.g. user name, abbreviation or number) and passwords must be ruled out.

  • Regular updating: It must be ensured that codes and passwords are continuously checked for security.

Loss management and general protective measures:

  • There must be a procedure in place for the loss of codes, passwords, cards and the like, e.g. to enable "de-authorization".

  • Suitable measures must be taken to protect and detect unauthorized access attempts.

  • The input/output devices, including the cards that carry or read authorization information, must be checked regularly for correct functioning.

Conclusion: The importance of FDA compliance for companies

Compliance with FDA regulations is crucial for companies. By ensuring FDA compliance, companies can ensure that their products meet stringent safety and quality standards. FDA compliant products enjoy consumer confidence and facilitate access to key markets, leading to improved competitive position and long-term success. In addition, FDA compliance can help companies better position themselves in the global marketplace, as many international standards are based on FDA standards. Especially in FDA-regulated industries, the digital signature plays a crucial role and is a core element of the process landscape, as it helps to ensure the integrity and security of data and supports compliance with regulatory requirements.

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