The questions about 21 CFR Part 11 comes up almost daily when doing computer system validation and software validation:

“What is 21 CFR Part 11?”
“Does 21 CFR 11 apply?”
“What about CFR 21 Part 11?” etc

So over the next few weeks; we are going to do a series of articles explaining this topic.

So lets start with some background on Part 11 and a definition from the guidance document:

In March of 1997, FDA issued final part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.

“Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency”

The original guidance raised many concerns that it did:

1. unnecessarily restrict the use of electronic technology in a manner that is inconsistent with FDA’s stated intent in issuing the rule,
2. significantly increase the costs of compliance to an extent that was not contemplated at the time the rule was drafted,
3. discourage innovation and technological advances without providing a significant public health benefit.

In 2003, the FDA issued a new guidance document : “Part 11, Electronic Records; Electronic Signatures – Scope and Application”. This guidance relaxed some of the earlier Part 11 criteria and is the one I will be basing the interpretation on. Even though the new guidance relaxed some criteria, predicate rules still apply.

The Part 11 requirements must be fulfilled where:

1. Quality Record or document specifying product or raw material is sent electronically.
2. Quality Record or document specifying product or raw material is stored electronically and no paper copy exists.
3. A Quality Record or document specifying product or raw material is stored electronically and a paper copy exists but the electronic copy is the one used it practice.
4. Data which will later be used to generate a Quality Record is stored electronically.
5. Data which will later be used to make Quality related decisions is stored electronically.
6. Any data or records sent electronically to the FDA.