21 CFR Part 11 Software

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.

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:

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.