User:Shawndouglas/sandbox/sublevel9

2. Sample Management

Regulation, Specification, or Guidance Requirement ASTM E1578-18 C-2-1 EPA ERLN Laboratory Requirements 4.11.14 The system shall record and maintain the chain of custody for the laboratory's standards and reagents. ASTM E1578-18 C-2-2 EPA ERLN Laboratory Requirements 4.11.14 The system shall record the current and historical storage location for the laboratory's standards and reagents. ASTM E1578-18 C-2-3 EPA ERLN Laboratory Requirements 4.11.14 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value. ASTM E1578-18 C-2-4 EPA ERLN Laboratory Requirements 4.11.14 The system shall require the recording of a standard and reagent's first opening date. ASTM E1578-18 C-2-5 EPA ERLN Laboratory Requirements 4.11.14 The system shall allow only active standards and reagents to be shown as available for use. ASTM E1578-18 C-2-6 EPA ERLN Laboratory Requirements 4.11.14 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel. ASTM E1578-18 C-2-7 The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status. ASTM E1578-18 C-2-8 EPA ERLN Laboratory Requirements 3.2 [ISO/IEC 17025:2017 7.4.2 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology. 7 CFR Part 331.17 9 CFR Part 121.17 21 CFR Part 211.84 42 CFR Part 73.17 ASTM E1492-11 4.2.1 ASTM E1578-18 C-2-9 The system should provide a means to manually or automatically track sample inventory amounts and status. [ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1 ASTM E1578-18 C-2-10 The system shall be able to link test methods and specifications to standards and reagents. 21 CFR Part 211.84 21 CFR Part 211.166–7 21 CFR Part 211.194 (e) 21 CFR Part 212.40 (c) 21 CFR Part 212.61 21 CFR Part 212.70 (e) 21 CFR Part 225.58 21 CFR Part 226.58 21 CFR Part 606.65 (c) 21 CFR Part 606.151 ASTM E1578-18 C-2-11 EPA ERLN Laboratory Requirements 3.1.2.1 EPA ERLN Laboratory Requirements 4.3.2 EPA ERLN Laboratory Requirements 4.11.3.2 EPA QA/G-5 2.2.5 USDA Administrative Procedures for the PDP 8.5 WHO Technical Report Series, #986, Annex 2, 17.7 WHO Technical Report Series, #986, Annex 2, 17.22–25 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.

3. Core Laboratory Testing/Experimenting

Regulation, Specification, or Guidance Requirement 21 CFR Part 211.84 (d) ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1 ASTM E1578-18 C-3-1 ISO 15189:2012 5.3.2.7 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use. 21 CFR Part 211.84 (e) 42 CFR Part 493.1252 (d) ASTM E1578-18 C-3-2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments. 42 CFR Part 493.1252 (d) ASTM E1578-18 C-3-3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing. ASTM E1578-18 C-3-4 The system shall be able to check physical, control, and specification limits for an instrument sample. ASTM E1578-18 C-3-6 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test. ASTM E1578-18 C-3-7 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet. ASTM E1578-18 C-3-8 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes. ASTM E1578-18 C-3-9 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest. ASTM E1578-18 C-3-10 The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results. AIHA-LAP Policies 2018 2A.7.8.2 ASTM E1578-18 C-3-11 The system shall allow users to enter operators such as <, >, +, and - with numeric test results. ASTM E1578-18 C-3-12 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions. 42 CFR Part 493.1241 ASTM E1578-18 C-3-13 EPA ERLN Laboratory Requirements 4.9.11 The system should effectively alert users upon entry of out-of-specification test results. 21 CFR Part 211.194 21 CFR Part 212.60 (g) 21 CFR Part 606.160 ASTM E1578-18 C-3-14 EPA ERLN Laboratory Requirements 3.1.2.3–4 EPA ERLN Laboratory Requirements 3.2 EPA ERLN Laboratory Requirements 4.3.4 EPA ERLN Laboratory Requirements 4.8.1–4 EPA ERLN Laboratory Requirements 4.11.16 USDA Data and Instrumentation for PDP 5.4.2 USDA Data and Instrumentation for PDP 8.1.3 WHO Technical Report Series, #986, Annex 2, 15.8 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.