What is expected by way of document control for software as required in Section 4.3.1?
The term "software" as used in section 4.3 includes those pieces of software and firmware required for proper operation of equipment, as well as those used for other purposes necessary for the correct performance of testing or analysis of data. The laboratory must control this software to ensure that personnel and equipment are using the correct versions. In many cases, this control may be included in the procedures by which the laboratory maintains and controls its equipment under Section 5.5 (e.g., when the software is integral to the equipment). All requirements of 4.3.1, 4.3.2 and 188.8.131.52 (a-d) as well as the pertinent requirements in section 5.5 must be met.
(NOTE: Word processing software does not have to be controlled unless it is used for calculation of derived data.)