An introduction to electronic data management

1. An Introduction to
Electronic Data Management…
Electronic Data Management
Audit Trail
Electronic
Record
Raw Data Signed Electronic Record
Electronic Printed Date &
Meaning
Data Meta Data name Time

2. A Definition…
• Electronic data/record is… any
combination of text, graphics, data, audio,
pictorial, or other information representation
in digital form that is created, modified,
maintained, archived, retrieved, or distributed
by a computer system.
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3. What is an Electronic Signature…
• An Electronic Signature (E-sign) is…a
computer data compilation of any symbol or
series of symbols executed, adopted, or
authorized by an individual to be the legally
binding equivalent of the individual’s
handwritten signature.
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4. What is Raw Data…
• Raw data is all available data that provides
context to the electronic data set or electronic
record.
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5. What are E-Sign requirements…
• A signed electronic record contains the following
elements:
Printed Date & Meaning
name of Time of
signer Signature
• This information must be included in a readable
form of electronic record.
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6. Biometric Electronic Signatures…
• What is an example of a Biometric Electronic
Signature?
– Fingerprint Recognition
– Photographic image
– Voice recognition
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7. Non-Biometric Electronic Signatures…
• What is an example of a Non-Biometric
Electronic Signature?
– User ID / Password
– Identification codes
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8. Electronic Regulations…
• Food, Drug and Cosmetic Act
• Public Health Service Act Sec. 351
• Title 18 US Code
• 21 CFR Part 11
• Sarbanes-Oxley (SOX)
• HIPAA
• 1999/93/EC
• Data Privacy
• Other…
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9. Key-elements Electronic Signatures…
• Key elements of the biometric or non-
biometric electronic signature are:
– Identify of signer
– Intent to sign
– Link of signature with singed document
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