Electronic Signature

What is an e-signature? 

The 21 CFR 11 defines the e-signature and e-record in the following way:  
Electronic signature refers to a series of symbols, or any computer data compilation executed, authorized, or adopted by an individual to be legally binding just as a handwritten signature

What are the benefits of e-signatures?

To modernize and unify the systems, organizations may benefit from choosing to sign of documents electronically. 

E-signatures are 

  • Efficient – Speed up every transaction and process by having recipients e-sign documents. 
  • Cost-effective. Using e-signatures helps reduce spending on paper, ink, and postage, meaning cost savings. 
  • Legally binding – Electronic signatures are legally valid and enforceable in almost everywhere in the world. 

What regulations covers an electronic signature?

21 CFR Part 11 more commonly referred to as “Part 11” is a set of rules that specify the requirements for electronic records and signatures. In section 11.1 Scope (a), the regulation defines the criteria for electronic records and electronic signatures under which they are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. 

FDA defines “scope” of the regulation in the following way:  “(b) 21 CFR Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth by the FDA.” Therefore, the regulatory framework applies to any company within the FDA-regulated industry that manages electronic records and electronic signatures. 

Annex 11 is the FDA 21 CFR part 11 European equivalent. It is a guidance system for electronic records and electronic signatures in the pharmaceutical industry. While 21 CFR part 11 is only applicable for electronic records, EU GMP Annex 11 is not limited to electronic documents. The EU system applies to software, hardware, risk management and personal. 

What are the requirements for an electronic signature? 

To comply with the regulations, an electronic signature must meet the following attributes: 

  • Authentication i.e., distinct identification components required to access the system for electronic signatures e.g., email address and password as well as identification component required per signature such as a password. 
  • Signature Meaning  (Signing Reason) 
  • Signature Manifestation including signature, unique ID, printed name and date/time of signing 
  • Signing Reason (Signature Meaning) 
  • Transaction History i.e., detailed audit trail and certificate of completion

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