Control of data of ISO 17025


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Control of data of ISO 17025
Clause 5.4.7

5.4.7.1 Calculations and data transfers shall be subject to appropriate checks in a systematic manner.

5.4.7.2 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:

a) computer software developed by the user is documented in sufficient detail and is suitably validated as being adequate for use;

b) procedures are established and implemented for protecting the 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;

c) 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.

NOTE Commercial off-the-shelf software (e.g. wordprocessing, database and statistical programs) in general use within their designed application range may be considered to be sufficiently validated. However, laboratory software configuration/modifications should be validated as in 5.4.7.2 a).

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