Guide to 21 CFR Part 11 Requirement and Compliance

We often see and hear the term 21 CFR Part 11 or commonly abbreviated as 21 CFR 11 in many instruments and software that are used in most industrial sectors. 21 CFR 11 is an internationally recognized requirement, that's why most instruments and software that have 21 CFR 11 are from abroad or imported products.

So, what is a 21 CFR 11? 21 CFR 11 is an acknowledgment certificate issued by the FDA (Food and Drug Administration) a department of health and public services of the United States, the same as in Indonesia, i.e. BPOM (Food and Drug Supervisory Department). The abbreviation of CFR refers to the "Code of Federal Regulations", it has several regulations that have been made and issued by the United States government.

The CFR has approximately 50 regulations, such as regulations on agriculture, health, government, banking, and many more. 21 CFR 11 means the rule number 21 part 11, 21 refers to section while 11 means sub-section. Section 21 of the CFR is a regulation that regulates foods and drugs, while sub-section 11 refers to a specific regulation that regulates the handling of electronic records and electronic signatures in the foods and drugs industry.

These electronic records and signatures have been recognized and validated, so there is no need to be afraid if there are no physical / original signatures. Any industrial sector such as health / pharmaceutical, foods, and beverages, cosmetics, etc. which already have 21 CFR 11 means it has been approved and included in the GMP (Good Manufacturing Practice) criteria or the drug manufacturing industry.

Not only being recognized, but the instruments and software that already have 21 CFR 11 will ensure the validation, authenticity, integration, and confidentiality of electronic data used, both in terms of data collection and analysis. The following are some of the benefits of 21 CFR 11 on instruments and software:

  • Security control and validation for user identification.
  • Detailed audit trail.
  • Legacy systems.
  • Copies of records and record retention.
  • Ease of electronic signatures.

Hartech Indonesia is one of the largest distributors in Indonesia for life science, laboratory equipment, and consumables products. We provide the best choices of products from our trustworthy partners to serve and support your laboratory or workplace needs and goals, and we guarantee you that all of our products already have the 21 CFR 11 requirement and compliance. 

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