Summary SOCRA Exam
Electronic Records - Use of electronic records must have procedures to ensure the authenticity, integrity and confidentiality of records. Also, the procedures must ensure the signer cannot readily repudiate the signed records a snot genuine Electronic Records - Audit Trail - Electronic records must use secure, computer generated, time-stamped audit trails to independently record the date and time of entries and actions that create, modify or delete records. Electronic Records - Changes - Record changes must not obscure previously recorded information Electronic Records - Audit Trail Retention - Audit trail documentation must be retained for a period at least as long as that required for the subject electronic records and must be available for agency (FDA) review and copying.
Document information
- Uploaded on
- January 23, 2023
- Number of pages
- 46
- Written in
- 2022/2023
- Type
- Summary
