We are sometimes asked if AirMed meets FDA standards. First, please be aware that the FDA is a department of the US government. The specific portion of FDA regulations relevant to software such as AirMed is part CFR 21. As it is an American standard, Health Canada does not require CFR Part 21 compliance as part of the Cannabis Act Regulations. And while AirMed was designed for the Canadian cannabis industry and to comply with Health Canada regulations, AirMed does conform to CFR Part 21 with respect to electronic record keeping, audit trails, and electronic signatures. 

Many agencies throughout the world are responsible for issuing and enforcing regulations that affect businesses. The regulations affecting software such as AirMed are typically those related to records management compliance. And while there are many regulatory agencies involved in records management, for the most part the regulations themselves are similar from country to country and agency to agency. The purpose of them, in general, is to ensure the security, confidentiality and authentication of electronic records.

The U.S. FDA regulates food, drugs, medical devices, biologics, animal feed and drugs, cosmetics and radiation-emitting products such as cell phones for the U.S.A. The FDA’s rules for manufacturing and distribution are designed to protect consumers and promote public health. In the U.S. Code of Federal Regulations (CFR), Title 21 deals with Food & Drugs. Until recently, the regulations in this title required paper records with handwritten signatures.

Back in 1997, part 11 of 21 CFR was enacted to cover the use of electronic records and electronic signatures. Commonly known as 21 CFR 11, this part defines the criteria “under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.”

Essentially, the concerns about using electronic records are that records may be lost in a system crash, the data may become corrupt or modifications may be made without proper authorization. In addition, since printed documents with hand-written signatures are recognized as legally binding on the signators, the agencies are looking for ways to make electronic records similarly binding on their owners. The regulations have been proposed to ensure that whenever an organization replaces printed documents with electronic data, there are checks and balances in place to ensure integrity of the electronic records so that they can be legally equivalent to printed records.

AirMed has a range of features that satisfy standards for security, authentication, validation and auditing as outlined in 21 CFR 11 and other regulations. For more detailed information on exactly how AirMed satisfies these requirements, please use the contact form and we will provide you with comprehensive documentation.