An introduction to electronic data management

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An introduction to electronic data management

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An introduction to electronic data management

  1. 1. An Introduction toElectronic Data Management…Electronic Data Management Audit TrailElectronic Record Raw Data Signed Electronic RecordElectronic Printed Date & Meaning Data Meta Data name Time
  2. 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. Visit our website for more articles, examples and best practices…
  3. 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. Visit our website for more articles, examples and best practices…
  4. 4. What is Raw Data…• Raw data is all available data that provides context to the electronic data set or electronic record. Visit our website for more articles, examples and best practices…
  5. 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. Visit our website for more articles, examples and best practices…
  6. 6. Biometric Electronic Signatures…• What is an example of a Biometric Electronic Signature? – Fingerprint Recognition – Photographic image – Voice recognition Visit our website for more articles, examples and best practices…
  7. 7. Non-Biometric Electronic Signatures…• What is an example of a Non-Biometric Electronic Signature? – User ID / Password – Identification codes Visit our website for more articles, examples and best practices…
  8. 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… Visit our website for more articles, examples and best practices…
  9. 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 Visit our website for more articles, examples and best practices…

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