Electronic Record Requirements

Question 1

E-records must have documented procedures and controls to address:

Answer 1

1. Data validation- proves e data can be trusted.
2. Rendering records- records available in a readable format.
3. Doc storage and record retention- ensures data available through retention period.
4. System access- protection ensuring comp access only provided to appropriate individuals
5. Audit trails
6. Workflows
7. Authority checks
8. Device check
9. Personnel qualifications
10. Personnel accountability
11. Document and system operation controls.

Question 2

Electronic Record software systems must be able to validate the records:

Answer 2

Authenticity
Integrity
Confidentiality
Irrefutability

Question 3

Requirements for e signature validity

Answer 3

Printed name of signer
Date and time of signature
Purpose of signature (i.e. content accurate)
Signatures must reman connected to record forever.

Question 4

Non biometric e signatures must have

Answer 4

1. Two distinct parts ie. UN and PW
2. Only to be used by “owner”
3. Exception to #2 requires two people to authenticate. ie..PI dies