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Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten
paper signatures?
Yes (although permission to use such e-sigs has to be approved by the FDA)
Does the FDA consider electronic records that meet requirements to be equivalent to
handwritten records ?
Yes
Open system (FDA term)
System access is NOT controlled by people who are responsible for the content of the
electronic records in the system. (Like me putting data into CHOP - controlled databases)
Closed system (FDA term)
Environment in which SYSTEM ACCESS is controlled by the same people responsible for
the content of the system (I.E. I control the Robotic Database access AND its contents)
What are some FDA Standards to meet when operating a closed record system?
1. Must be able to tell if records have been altered or invalid
2. Must be able to copy records for agency review
3. Protect records throughout retention period
4. Limit system to authorized individuals only
5. Use time-stamped audit trails of modification etc
6. Use operational system checks and restrictions
7. Use authority checks to make sure only authorized individuals are using the system
8. Use device checks to validate data input
9. Make sure those authorized to use system have appropriate training, education, experience
10. Have written policies that deter data falsification
11. Audit and control the maintenance of the actual system
What are some FDA standards to meet when using an Open System?
All those mentioned for the closed system.
1. Document encryption as appropriate
What information should a handwritten SIGNATURE block contain?
1. Printed name of signer
2. Date and Time when signature was executed
3. The MEANING associated with the signature (approval? responsibility? authorship?)
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