Automated systems validation

Question 1

What should automated systems validation documentation cover

Answer 1

The systems lifecycle:
use risk assessment
GAMP category should drive validation strategy
Include change control and deviation reports

Maintenance of Up-to-date system inventory

Question 2

What should in included in automated systems validation

Answer 2

GAMP category should drive requirements e.g. vendor audit, source code review etc

Error handling

Transfer of data and back up

Data recovery

Data integrity, password controls and audit trail