1.1 This guide covers general requirements for data integrity for computer operations in a laboratory. This guide expands upon the requirements of paragraph 10.7 in ISO/ IEC Guide 25 (currently being balloted as a replacement for Guide E548) for those laboratories that are highly computerized and is intended to be used in conjunction with ISO/IEC Guide 25 in the assessment of testing laboratories.
1.2 This guide presents requirements that are generally in harmony with and in addition to those in Guide E548 and ISO/IEC Guide 25; the paragraphs dealing with similar subjects carry similar numbers.
1.3 Additional requirements may be necessary for fields of testing where the computer system(s) are integrated into the test methods themselves. These requirements can normally be found in the test methods.
1.4 In highly computerized laboratories, computers are increasingly being used for:
1.4.1 Direct capture of data from instruments and testing machines;
1.4.2 Automatic control and monitoring of test processes;
1.4.3 Control of critical environmental conditions;
1.4.4 Capture, processing, and display of laboratory quality-control data;
1.4.5 Basic data processing;
1.4.6 Data storage and retrieval;
1.4.7 Generation of test reports;
1.4.8 Scheduling and monitoring of work throughput;
1.4.9 Monitoring and control of inventories;
1.4.10 Equipment inventories, and calibration and maintenance schedules;
1.4.11 Design of statistical experiments; and
1.4.12 Communication between laboratories (and with clients).
1.5 The assessment of the highly computerized laboratory will depend upon the nature of the computer systems and the functions they are intended to perform. This guide may be useful in assessing portions of computer systems in less highly computerized laboratories.
1.6 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Accreditation requirements; Data analysis-computerized; Computerized systems; Highly computerized laboratories; Laboratory-clinical; Laboratory accreditation; Performance-laboratory instrumentation; Quality assurance (QA); data integrity-highly computerized laboratory operations, guide;
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