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  • What is 21 CFR Part 11?

    Published On: 01/19/15

    The main objective of Food and Drug Administration (FDA) is to protect and promote the public health of United States citizens. Fulfilling its responsibilities diligently, the agency has implied strict regulations on the industries dealing with medical equipments, drugs, food supplies, radioactive products, other biological compounds, cosmetics and more, to follow rules and regulations. These rules are designed to maintain security, safety, and efficient use of these products. The guidelines issued by FDA in interest of the people ensure that they are not misguided by any product that is not safe for public use or violate the industry standards.

    Title 21, Code of Federal Regulations, Part 11 simply referred to as 21 CFR part 11, is one such regulation that details regarding the use of Electronic Records and Electronic Signatures (ERES). Broadly speaking, it mandates drug manufacturers, medical equipment manufacturers, biotech companies, biological industries, and other FDA-regulated industries, to implement controls, including system validations, audits, electronic signatures, audit trails, and documentation for systems and software involved in the generation and processing of electronic data.

    21 CFR Part 11 - Security Guidelines

    21 CFR Part 11 outlines a number of rules to ensure that only authorized persons have access to computer systems and certain records, in order to maintain the integrity, security and traceability of critical and confidential data. These rules ensure the sustainability of the software product and the processing of data for a defined period of time.  There are two types of systems:  the closed system and the opened system. In a closed loop system, system access is restricted to the individuals who are responsible for the creation or management of electronic record content that are on the system while in an open system, system access is denied even for individuals who are responsible for the contents of the electronic records.

    21 CFR Part 11 - Electronic Signatures

    The FDA 21 CFR Part 11 regulations also outline general requirements for an electronic or digital signature which is legally equivalent to a handwritten signature, such as the reader should be clearly able to identify the person or organization that has signed it, and that the document has not been tempered with between the time when the authorized person has signed and when the reader read. They must be authentic, unfalsifiable, unaffected, not reusable and irrevocable. This mechanism ensures the integrity of an electronic document and the identity of the authorized signatory.


    Though, these guidelines are for the welfare of consumers but for industries especially for medical device companies, it has given rise to serious challenges.  The companies usually fail to comply with these regulations either due to technical constraints, time constraints or due to lack of information and strategies available to implement it effectively. Especially, startups and smaller industries are more concerned with the risks and costs in ensuring that their electronic systems comply with these requirements. 

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