Data Processing of Quality Control Lab Equipment. Detailed recommendations are provided in Appendix 5 to Annex 4 of the Fortieth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations: Supplementary guidelines in good manufacturing practice: validation. Validation of computerized systems (12).
For computers, automated tests or calibration equipment, and the collection, processing, recording, reporting, storage or retrieval of test and/or calibration data, the laboratory should ensure that:
- computer software developed by the user is documented in sufficient detail and appropriately validated or verified as being suitable for use;
- procedures are established and implemented for protecting the integrity of data. Such procedures should include, but are not limited to, measures to ensure the integrity and confidentiality of data entry or collection and the storage, transmission and processing of data. In particular, electronic data should be protected from unauthorized access and an audit trail of any amendments should be maintained;
- computers and automated equipment are maintained so as to function properly and are provided with the environmental and operating conditions necessary to ensure the integrity of test and calibration data;
- procedures are established and implemented for making, documenting and controlling changes to information stored in computerized systems; and
- electronic data should be backed up at appropriate regular intervals according to a documented procedure. Backed-up data should be retrievable and stored in such a manner as to prevent data loss.
Note: For further guidance on validation of data-processing equipment, refer to documents published by the International Society for Pharmaceutical Engineering (13, 14), US Food and Drug Administration (15), European Commission (16) and the Official Medicines Control Laboratories Network of the Council of Europe (17).