By Seed And Beyond | Blogs |
Seed and Beyond Cannabis ERP software is compliant with FDA 21 CFR Part 11 guidelines and regulations. As a Cannabusiness owner, you would have heard about Food and Drug Administration’s (FDA’s) 21 CFR Part 11 regulation. Here is a guide to help you understand what it means and how Seed and Beyond Cannabis ERP software plays in role in ensuring your business is compliant with the 21 CFR Part 11 regulations.
What is FDA 21 CFR Part 11 Compliance
Let’s begin with decoding 21 CFR Part 11 :
21: “Title 21” is the section of the CFR that applies to food and drugs.
CFR: “Code of Federal Regulations” is a coded (numbers and letters) set of laws published by the federal government of the United States.
Part 11: “Part 11” is the scope which is specific to electronic records and electronic signatures, which includes electronic submissions to the FDA.
The FDA issued the final Part 11 regulation in March 1997, and it became effective on August 1997. According to the 21 CFR Part 11, the definitions of electronic record, electronic signature and hand written signature are as follows:
Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
Electronic signature means 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.
Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.
The security and protection concerns about managing the distribution, storage, and retrieval of records by biotechnology, drug, and medical equipment manufacturers in this digital age paved way for 21 CFR Part 11 regulations.
The scope covered in Part 11 has guidelines to ensure that electronic records and electronic signatures can be trusted as much as the paper records and handwritten signatures. All electronic records that are used for regulated purposes are subject to Part 11. However, a paper record that is transmitted electronically (for example, as an email attachment) is NOT subject to Part 11.
If an organization can prove, via a computer system validation, that the electronic signatures are compliant with Part 11, the FDA will accept electronic signatures instead of ink. These records are subjected to audits & inspections by the FDA at any point of time.
How does Seed and Beyond help you stay compliant with 21 CFR Part 11 guidelines?
Seed and Beyond’s Cannabis ERP software use the protocols laid out of 21 CFE Part 11 as part of its processes across every module. Here’s how Seed and Beyond software ensures compliance:
