Computerised systems
Article 20
1. Computerised systems related to the good manufacturing practices for active substances shall be validated, taking into account the diversity, complexity and criticality of the computerised system. 2. Appropriate installation qualification and operational qualification shall demonstrate the suitability of computer hardware and software to perform assigned tasks. 3. Commercially available software that has been qualified shall not require the same level of testing as non-commercially available software. Where an existing computerised system is not validated at the time of installation, a retrospective validation shall be conducted if appropriate documentation is available. 4. Computerised systems shall have controls preventing unauthorised access, changes to data and omissions in data. All changes in data shall be recorded and reviewed in the audit trail. 5. Written procedures shall be available for the operation and maintenance of computerised systems. 6. Where critical data are entered manually, an additional check on the accuracy of the entry shall be performed by a second operator or by the system itself. 7. Incidents related to computerised systems potentially affecting the quality of the active substances or intermediates thereof, or the reliability of records or test results, shall be recorded and investigated. 8. Changes to the computerised system shall be made in accordance with a change control procedure and shall be formally approved, documented and tested, where appropriate. Records shall be kept of all changes to the computerised system., including modifications and enhancements made to the hardware, software and any other critical component of the system. Those records shall demonstrate that the computerised system is maintained in a validated state. 9. A back-up system shall be in place to prevent computerised system breakdowns or failures resulting in the permanent loss of records. 10. Data protection shall be ensured for all computerised systems. 11. In addition to the computerised system, data may be recorded by a different means.