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Section 4: Tips for setting up your electronic signature for the FDA

Introduction – Setting up your electronic signatures


If you are using Version Control or operating a 21 CFR Part 11 compliance laboratory and want to use electronic signatures there are certain protocols you must follow to declare that signatures used on records are legally binding equivalents to handwritten signatures.

For additional 21 CFR Part 11 implementation see Version Control Compliance Guide the document presents the technical features of Version Control in regards to FDA 21 CFR Part 11 and how these individual regulations can be satisfied with Version Control to help your organisation comply with the Food and Drug Administration’s FDA 21 CFR 11 regulations.

Who is this for

  • Quality, Research & Development Manager

Requirements for electronic signatures

Before reading the document please note that we do not represent any government agency and nothing in the in this guide should be taken as fact. The regulations we provide are true to the publishing date. You should check FDA guidelines and regulations for implementing your own electronic signatures.

 

The following text is taken directly from the Title CFR 21 Part 11 guidelines. The complete regulations can be found on the U.S. Food and Drug Administration (FDA) website.

“Before using electronic signatures, or at the time of use, persons using electronic signatures must certify to the Agency the electronic signatures used in their system on or after August 20, 1997, are intended to be the legally binding equivalent of handwritten signatures.

The above-mentioned certifications must be in paper form and signed with handwritten signatures and submitted to ORO/DEIO (HFC-130).

On request, persons must provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer=s handwritten signature.”

Key Takeaways

• The certificate must be submitted to the FDA in writing prior to assigning that individuals electronic signature. A certificate can broadly cover the electronic signature of all current and future employees and may not be required for individual persons.

• An organisation should also confirm the identification of the individuals using electronic signatures. The FDA does not specify any particular method for verifying the identity of an individual and accepts many different methods.

What’s next?

Setting up your electronic signatures for the FDA can be an easy process, following our guidelines above can be used as a starting point for your compliance needs. If you would like a demonstration of Version Control to help your compliance with 21 CFR Part 11 for life science organisations operating in GMP/GLP labs, get in touch.