Title 21 of the United States Code of Federal Regulations Defines the Rules of the Food and Drug Administration.

Pharmaceutical, Medical Device, Biotechnology and Food manufacturers must comply with the requirements of FDA 21 CFR in the production, distribution and sale of their respective products in the U.S. market. It not only makes sense to do so because it is required. It makes sense to comply with 21 CFR since it was put into place for a reason. Specifically, to reduce risks and improve patient safety. Thusly, 21 CFR compliance pays many dividends.

Compliance with 21 CFR Part 11

When introduced as part of 21 CFR Part 11 Electronic Records, Electronic Signatures was acknowledged by both industry and FDA as an important addition. Since Part 11’s inclusion in 21 CFR, the attitude of the FDA toward compliance has evolved from one of relative inattention to one of active review and investigation. In fact, today the FDA has asked industry to provide specific action plans that will bring companies into compliance. The Agency has now trained its inspectors in the Part 11 rule and its interpretation. Although the rule provides a challenging situation, it is clearly in the best interest of all FDA regulated companies to actively undertake projects that will bring them into compliance.

FDA 21 CFR Links & Resources

The following link to the FDA website describes the Title in more detail and provides instructions for searching the on-line 21 CFR database: About 21 CFR. We have also included several direct links to the FDA website, which highlight the primary “Parts” and “Subparts” of 21 CFR for which Innovatum solutions and services are ideally suited. Please note, however, that our products and services are not necessarily limited to the following regulations:

• Part 1, Subpart B — General Labeling Requirements
• Part 11 — Electronic Records; Electronic Signatures
• Part 26 — Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, And Certain Medical Device Product Evaluation Reports: United States and the European Community
• Part 101 — Food Labeling
• Part 201 — Drug Labeling
• Part 203 — Prescription Drug Marketing
• Part 801 — Medical Device Labeling
• Part 803 — Medical Device Reporting; Subpart E — Manufacturer Reporting Requirements
• Part 809 — In Vitro Diagnostic Products for Human Use
• Part 820 — Quality System Regulation
• Part 821 — Medical Device Tracking Requirements
• Part 1271 — Human Cells, Tissues, and Cellular and Tissue-Based Products; Subpart D — Current Good Tissue Practice
• Part 1302 — Labeling and Packaging Requirements for Controlled Substances

Please contact Innovatum to learn how our enterprise compliance software systems and professional services can help your company meet the technology challenges of regulatory compliance.