Speciality Labs

Microbiology Analyzer Quality Assurance, Verification and Compliance Policy

Qualification, function checks, version control and downtime management

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Microbiology Analyzer Quality Assurance, Verification and Compliance Policy

What You'll Find Inside

14 pages. Covers instrument selection, three stage qualification and performance verification with what must be demonstrated for eight instrument classes before clinical use. Includes routine function checks by instrument type, control of software, database and library versions as changes to reported results, method correlation assessed by error type, downtime with a maintained backup, engineer access rules, and a register separating compliant from modified use.