Data Safety and Integrity
21 CFR Part 11 requires that electronic data be persistent, and that any changes to the data be recorded in an audit trail. ASTRA and DYNAMICS employ three methods to ensure this:
- All data and audit trails generated by ASTRA and DYNAMICS under Security Pack mode are stored in a secure, ODBC-compliant database. The database can be networked for automatic back-up by the IT department. This ensures that data will not be lost, and that any changes to the data will be associated with an audit trail in the same database.
- Encrypted checksums: Each entry in the database has an encrypted checksum. ASTRA and DYNAMICS use this checksum to verify that the data being read from the database has not changed since it was last written, and notify the user of any data corruption or any attempt to alter the data.
- Results comparison: (ASTRA only) ASTRA stores computed results in the database. Each time the data are reprocessed through ASTRA the results are compared against the historical version in the database. If the results change, ASTRA notifies the user so that appropriate action can be taken. This feature can be extremely helpful in validating software updates or new installations.