Day

December 3, 1996
WARN 12/03/96 Berlex Appropriate controls are not exercised over the [purged text] Software, used by Quality Control and Technical Services, to assure that changes in laboratory control records are instituted only by authorized personnel. There are no written procedures defining the appropriate use for the abort, terminate, suspend, restart, and stop functions which are accessible...
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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

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