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Complying with Document Control Regulations
FRANCES GARCIA, EVELYN HARRISON, CAROL WISE, AND DONNA M. WOLK
Clinical laboratories, faced with new or changing regulations and shortages in trained laboratory staff, may find it difficult to comply with guidelines related to document control, upkeep of standard operating procedure manuals, and documentation of quality programs or competency reviews. Now, more than ever, it is critical to keep documents, procedures, and training material organized and accessible to busy laboratory staff and inspectors. The key may be the ability to use existing software programs available to industry for similar compliance issues. The laboratory’s ability to change and update quickly with limited staffing may depend on electronic solutions to the complexities of document control. Several software programs have merit and can be integrated into a clinical laboratory...
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