Category Archives: Data Integrity

How to Store an Electronic Signature

Electronic Signature

Hello good people of the world! Today’s post is a short one on the topic of electronic signatures. 21CFR11 includes requirements around the use of electronic signatures in place of traditional handwritten signatures and these requirements are fairly well understood at this point. The question of this post is, how should your electronic system store the electronic signature?

It is important to understand that electronic signatures are meta-data. That is, they are data about data. So if you have an electronic batch record, for example, the electronic signature recorded during approval is not part of the batch record data, but meta-data of the batch record data. In this example, it is specifically the who, what, and when of the batch record approval.

Given that, electronic signature data should not be included in the same record (table row, document, etc.) in the electronic system. It is meta-data and should be handled as such, an important consideration in electronic system design. This will ensure electronic signature data is robust, auditable, and readily available.

How do you store electronic signatures? Any lessons learned? Comment below.

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Warning Letter: Daito Kasei (Japan)

WarningLetterFDA

Hello good people of the world! Today’s post is about a recent (January 2018) warning letter issued by the FDA to a Japanese cosmetics and drug manufacturing company called Daito Kasei. The warning letter, which can be found here, underscores the need maintain focus on data integrity requirements in our modern age. This warning letter includes explicitly the following data integrity remediation steps: Continue reading Warning Letter: Daito Kasei (Japan)