21 CFR Part 11
Is Your Company Compliant?

In April, 2002, the US Food and Drug Administration (FDA) published an update to the Final Rule for Part 11 "Electronic Records; Electronic Signatures" of Title 21 of the Code of Federal Regulations (21 CFR Part 11). This rule states the conditions under which the FDA considers electronic signatures and electronic records to be trustworthy, reliable and equivalent to traditional handwritten signatures on paper. It defines the conditions under which a manufacturer or supplier must operate to meet its record keeping and record submission requirements when it uses electronic records and signatures rather than paper records and handwritten signatures.

At present, the use of electronic records as well as their submission to the FDA, is voluntary. However, where an organization does decide to use electronic records and electronic signatures, the requirements of the rule must be met in full for all relevant electronic records. This applies to the manufacturer, as well as the vendors supplying the manufacturer, and should a vendor not be in compliance, both vendor and manufacturer face penalties.

Compliance is required of anyone involved in the development, manufacturing and marketing of life sciences products, including drugs, diagnostics, and medical devices. It is also required of all companies operating under GMP, GLP, or GCP guidelines.

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Within the pharmaceutical industry, such regulatory requirements are nothing new. The FDA has long enforced strict guidelines for pharmaceutical manufacturers regarding the keeping of detailed records that define processes and procedures--from the designing stages through packaging, sales, and distribution. 21 CFR Part 11 was seen as a much-needed means to bring these record keeping procedures into the digital information age while still protecting public health.

Electronic records keeping provides a much less cumbersome process than traditional paper trails, and saves companies both time and money. It reduces errors, ensuring the reliability and authenticity of data, providing for increased process efficiencies, data management and company profitability. In fact, for this very reason many pharmaceutical companies have adopted company-wide, CFR-compliant data-handling policies, and are purchasing CFR-compliant equipment even for areas where it's not required.

The elements of compliance the FDA is looking for under 21 CFR Part 11 are the ability to prevent unauthorized changes to electronic records, the monitoring of all electronic signatures, the retention of electronic records, and the authentication of users with access rights to data. In addition, all changes to process and device configurations must be archived and be traceable via an electronic signature auditing trail. In short, 21 CFR Part 11 requires the creation of a detailed electronic trail of who did what, where, when, and for what reason.

Whether your 21 CFR Part 11 compliance program would stand up to an FDA audit is another matter. For added insurance you may want to contact one of the many consulting firms that specialize in 21 CFR Part 11 compliance. Hiring one of these firms to help you develop and implement a compliance program is not cheap. But then neither are the fines handed out by the FDA to companies that fail to properly meet the requirements of this regulation.

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