User:Shawndouglas/sandbox/sublevel14

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12. Scheduled Event Management

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-5-1
USDA Sampling Procedures for PDP 5.6–7
12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.
21 CFR Part 212.61 (a)
21 CFR Part 211.166 (b)
ASTM E1578-18 E-5-2
12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.
ASTM E1578-18 E-5-3 12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.
ASTM E1578-18 E-5-4 12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).
ASTM E1578-18 E-5-5 12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.

13. Instrument Data Capture and Control

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-6-1 13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.
ASTM E1578-18 E-6-2 13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.
ASTM E1578-18 E-6-3 13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.
ASTM E1578-18 E-6-4 13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.
ASTM E1578-18 E-6-5 13.5 The system should be able to accept the results uploaded from an interfaced instrument.
ASTM E1578-18 E-6-6 13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.
ASTM E1578-18 E-6-7 13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP/IP, and USB.
ASTM E1578-18 E-6-8 13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.