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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.

14. Standard and Reagent Management

Regulation, Specification, or Guidance Requirement 21 CFR Part 58.83 29 CFR Part 1910.1200 (g) 29 CFR Part 1910.1450 (h) 42 CFR Part 493.1252 (c) ABFT Accreditation Manual Sec. E-17 ASTM E1578-18 E-7-1 ISO 15189:2012 5.3.2.4–5 OECD GLP Principles 4.4 14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials. 7 CFR Part 331.3 9 CFR Part 121.3 21 CFR Part 312.58 (b) 42 CFR Part 73.3–4 (c) ASTM E1578-18 E-7-2 EPA ERLN Laboratory Requirements 4.1.12 ISO 15189:2012 5.3.2.4 WHO Technical Report Series, #986, Annex 2, 12.20 14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and/or chemical stability. ASTM E1578-18 E-7-3 ISO 15189:2012 5.3.2.4 14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand. ASTM E1578-18 E-7-4 ISO 15189:2012 5.3.2.4 14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results. ASTM E1578-18 E-7-5 ISO 15189:2012 5.3.2.4 14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.