Audit - 10
Audit Manual 10 - Auditing Computerised Systems
Identify computer systems with GMP implications within the scope of the GMP facility audit Include in the audit an assessment of the computerized systems used to support a GMP facility. Understand and apply applicable GMP requirements to the audit. Recogni
Audit 10 - Auditing Computerized Systems
Any GMP facility whether involved in contract testing, manufacturing, processing, packaging or distribution will rely to a greater or lesser extent on computerized systems. They are fundamental in ensuring that processes and data are reliable and secure. In order to achieve this they should be maintained in a validated state.
Validating a computerized system is establishing documented evidence that provides a high degree of assurance that it will consistently function in accordance with its pre-determined specifications and quality attributes throughout its life-cycle.
http://www.gmpsop.com/sample/Audit-010-Auditing-Computerised-Systems-sample.pdf
Any GMP facility whether involved in contract testing, manufacturing, processing, packaging or distribution will rely to a greater or lesser extent on computerized systems. They are fundamental in ensuring that processes and data are reliable and secure. In order to achieve this they should be maintained in a validated state.
Validating a computerized system is establishing documented evidence that provides a high degree of assurance that it will consistently function in accordance with its pre-determined specifications and quality attributes throughout its life-cycle.
http://www.gmpsop.com/sample/Audit-010-Auditing-Computerised-Systems-sample.pdf