EN ISO/IEC 17 025: requirements on Control of data

When computers or automated equipment are used for the acquisition, processing, recording, reporting, storage or retrieval of test or calibration data, the laboratory shall ensure that:

• computer software developed by the user is documented in sufficient detail and suitably validated or otherwise checked as being adequate for use:
• procedures are established and implemented for protecting the integrity of data; such procedures shall include, but not be limited to, integrity and confidentiality of data entry or collection, data storage, data transmission and data processing;
• computers and automated equipment are maintained to ensure proper functioning and are provided with the environmental and operating conditions necessary to maintain the integrity of test and calibration data.

Commercial software (text editors, databases, statistical software) in general use within its designed application range may be considered sufficiently validated. Configuration and modifications of the software should be validated.

Apart from ISO 17 025, detailed information regarding software validation can be found in:

• GAMP 4: Guide for Validation of Automated Systems, ISPE, December 2001
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff: FDA - CDRH, 11.1. 2002
• Good Practices for Computerized Systems in Regulated "GXP" Environments: PIC/S, Draft, 14.1. 2002.