This is the final post in the 21 CFR Part 11 “mini-series” on Subpart B – Electronic Records. The last Section in Subpart B is 11.70 – Signature/Record Linking.
In the table below, the actual language from each regulation is on the left, and my personal interpretation of what that language means is on the right. Keep in mind that I do not represent the FDA and nothing in the “Interpretation” column should be taken as fact.
11.70 – Signature/Record Linking
With that, we’ve made it through all of Subpart B – Electronic Records. Good work! With the next post, we’ll be moving into the home stretch by kicking off the mini-series on Subpart C – Electronic Signatures.
If you have questions between now and the next post, feel free to contact us. To read past posts in the 21 CFR Part 11 Decoded series, click here.
