In 1997, the United States Food and Drug Administration (FDA) issued a regulation that provided a criteria that should be used to accept electronic records, electronic signatures and handwritten signatures by FDA.

With this regulation, titled Rule 21 CFR Part 11, electronic records and signatures became as valid as paper records and handwritten signatures. FDA ruling 21 CFR Part 11 specifies how electronic records and electronic signatures can be used instead of paper records and handwritten signatures. It is broadly applicable to electronic records and also includes software that is responsible for developing and manufacturing drugs and medical devices, and research and biotechnology.

What are electronic records?

According to the FDA, an “electronic record means any combination of text, graphics, data, audio, pictorial, or other information represented in digital form. This electronic record is created, modified, maintained, archived, retrieved, or distributed by a computer system.” Not all electronic records comes under 21 CFR Part 11, only those that are maintained according to predicate rules published by FDA. Predicate rules are the requirements set forth in the Act, PHS Act, and FDA regulations. These rulings, such as the Good Laboratory Practice (GLP) and Current Good Manufacturing Practice (CGMP), specify what records must be maintained, what should be there in the record, whether signatures are required and how long records must be maintained.

What is an electronic signature?

Electronic signatures are digital equivalents of handwritten signatures. The FDA states that an “electronic signature is a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.”

This kind of regulation was important because electronic data handling gives lot of benefits in the pharmaceutical manufacturing areas.

These regulations are not only important in the United States but also in many other countries. There are two reasons:

  1. Many pharmaceutical companies located outside the US export drugs to the US market, and so they have to follow US regulations. If FDA checks these companies for US regulations and they find a mismatch then, the company is not allowed to export drugs to the United States,. This will result in tremendous business loss.
  2. Other countries may also have issues with electronic submissions and can use US rule as a guideline for their local regulation.

The use of electronic record is more cost effective for the industry and the FDA. The approval process is shorter and access to documentation will be faster and more productive. Following are few reasons why pharma industry will opt for use of electronic records.

  • In many situations using computers cannot be avoided
  • There may come a time when the FDA will prefer electronic records over paper records because of lower space requirements and easier retrieval.


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