Template:LIMSpec/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.