New FDA QMSR & 21 CFR Part 11 e-signature requirements

[Sam Lazzara]

True or False

Unlike the FDA 21 CFR 820 QSR, the new FDA 21 CFR 820 QMSR (effective in 2026) does not include signature requirements.
Also, there are no signature requirements in ISO 13485:2016, which is incorporated by reference into the QMSR.
Therefore, Part 11 requirements for electronic signatures do not apply to the QMSR.

QSR - Quality System Regulation
QMSR - Quality Management System Regulation

 

[Ed Panek]

I’m going to suggest regardless of FDA just implement part 11 anyways. Make it a business decision. Every pharma company we partner with expects it anyways.

 

[Nichole F]

I would think part 11 would still apply. In the responses to the public comments prior to the finalization of the rule, FDA stated

"FDA notes that where ISO 13485 uses the term “approved,” that term means that an approved document, or certain record of a type that requires approval by ISO 13485, has a signature and date. Additionally, we note that FDA will consider signatures that utilize the method the Agency determines fulfills electronic signature requirements to be compliant with this requirement. Manufacturers can choose to develop electronic records and electronic methods for denoting approval. Our focus is on whether the substance of the requirements is met and not the physicality of the record or signature methodology."

 

[pbojsen]

Part 11 is a requirement in itself, just like Recalls is. It's separate from Part 820.