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6. Reporting

Regulation, Specification, or Guidance Requirement ASTM E1578-18 C-6-1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested. EPA ERLN Laboratory Requirements 3.4 EPA ERLN Laboratory Requirements 4.1.4 EPA ERLN Laboratory Requirements 4.12–15 The system shall be able to export data in a computer-readable (importable into a relational database) format—such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file—as well as PDF format, for reporting purposes. 42 CFR Part 493.1291 (g) and (h) ASTM E1578-18 C-6-2 EPA ERLN Laboratory Requirements 4.11.4 EPA QA/G-5 2.4.2 The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements. ABFT Accreditation Manual Sec. G-2 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., "less than X mg/L") when doing so would provide relevant information to the report recipient. 40 CFR Part 141.33 42 CFR Part 493.1291 (c–e) AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2 AAVLD Requirements for an AVMDL Sec. 5.4.2.1 AAVLD Requirements for an AVMDL Sec. 5.10.2–5 AIHA-LAP Policies 2018 2A.7.8.1 ABFT Accreditation Manual Sec. E-12 and -32 ASTM E1578-18 C-6-3 EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8 EPA 815-R-05-004 Chap. VI, Sec. 8 ISO 15189:2012 4.5.2 ISO 15189:2012 5.8.3 ISO/IEC 17025:2017 7.5.1 ISO/IEC 17025:2017 7.8.1.1 ISO/IEC 17025:2017 7.8.2.1 ISO/IEC 17025:2017 7.8.3.1 WHO Technical Report Series, #986, Annex 2, 15.43 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates. ASTM E1578-18 C-6-4 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel. ASTM E1578-18 C-6-5 ISO 15189:2012 5.8.1 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance. 7 CFR Part 331.5 9 CFR Part 121.5–6 21 CFR Part 58.185 21 CFR Part 312.64 21 CFR Part 812.150 21 CFR Part 812.200 40 CFR Part 141.31 40 CFR Part 141.721 40 CFR Part 370 Subpart C 40 CFR Part 372 Subpart B 40 CFR Part 704 40 CFR Part 717 Subpart A 40 CFR Part 720.40 42 CFR Part 73.5–6 42 CFR Part 493.43 (d) ABFT Accreditation Manual Sec. E-7 ASTM E1578-18 C-6-7 CJIS Security Policy 5.3.1 EPA ERLN Laboratory Requirements 4.12–15 EPA QA/G-5 2.3.2 OECD GLP Principles 9.1 USDA Administrative Procedures for the PDP (throughout) The system should, in addition to standard reports, provide the means for custom reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports. 21 CFR Part 58 Sec. 58.185 (c) AAVLD Requirements for an AVMDL Sec. 5.10.9–10 ISO/IEC 17025:2017 7.8.8 OECD GLP Principles 9.1 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.

7. Document Management

Regulation, Specification, or Guidance Requirement 7 CFR Part 331 (throughout) 9 CFR Part 121 (throughout) 21 CFR Part 7 (throughout) 21 CFR Part 58 (throughout) 21 CFR Part 211 (throughout) 21 CFR Part 212 (throughout) 21 CFR Part 225 (throughout) 21 CFR Part 226 (throughout) 21 CFR Part 312 (throughout) 21 CFR Part 606 (throughout) 21 CFR Part 810 (throughout) 21 CFR Part 812 (throughout) 21 CFR Part 820 (throughout) 29 CFR Part 1910.134 (throughout) 29 CFR Part 1910.1030 (throughout) 29 CFR Part 1910.1200 (throughout) 29 CFR Part 1910.1450 (throughout) 42 CFR Part 73 (throughout) 42 CFR Part 493.1200 42 CFR Part 493.1232 42 CFR Part 493.1239 42 CFR Part 493.1251 42 CFR Part 493.1291 (j) 45 CFR Part 164 (throughout) AAFCO QA/QC Guidelines for Feed Laboratories (throughout) AAVLD Requirements for an AVMDL (throughout) ABFT Accreditation Manual (throughout) ASTM E1188-11 3.5.2 ASTM E1492-11 4.3.3.3 and 4.4.4 ASTM E1578-18 D-1-1 CJIS Security Policy (throughout) EPA 815-R-05-004 (throughout) EPA ERLN Laboratory Requirements (throughout) EPA QA/G-5 (throughout) E.U. Commission Directive 2003/94/EC (throughout) FDA Hazard Analysis Critical Control Point (throughout) ISO 15189:2012 4.3 ISO 15189:2012 5.5.3 ISO 15189:2012 5.9.3 ISO/IEC 17025:2017 5.3 ISO/IEC 17025:2017 5.5 ISO/IEC 17025:2017 8.3.2 OECD GLP Principles 8 USDA Administrative Procedures for the PDP (throughout) USDA Data and Instrumentation for PDP (throughout) USDA Sample Processing and Analysis Procedures for PDP (throughout) WHO Technical Report Series, #986, Annex 2 (throughout) The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls. 7 CFR Part 331 (throughout) 9 CFR Part 121 (throughout) 21 CFR Part 7 (throughout) 21 CFR Part 58 (throughout) 21 CFR Part 211 (throughout) 21 CFR Part 212 (throughout) 21 CFR Part 225 (throughout) 21 CFR Part 226 (throughout) 21 CFR Part 312 (throughout) 21 CFR Part 606 (throughout) 21 CFR Part 810 (throughout) 21 CFR Part 812 (throughout) 21 CFR Part 820 (throughout) 29 CFR Part 1910.134 (c) 29 CFR Part 1910.1030 (throughout) 29 CFR Part 1910.1200 (e) 29 CFR Part 1910.1450 (throughout) 42 CFR Part 73 (throughout) 42 CFR Part 493.1200 42 CFR Part 493.1232 42 CFR Part 493.1239 42 CFR Part 493.1251 42 CFR Part 493.1291 (j) 42 CFR Part 493.1773 (c–d) 45 CFR Part 160.310 45 CFR Part 164 (throughout) AAFCO QA/QC Guidelines for Feed Laboratories (throughout) AAVLD Requirements for an AVMDL (throughout) ASTM E1188-11 3.5.2 ASTM E1492-11 4.3.3.3 and 4.4.4 ASTM E1578-18 D-1-2 CJIS Security Policy (throughout) EPA 815-R-05-004 (throughout) EPA ERLN Laboratory Requirements (throughout) EPA QA/G-5 (throughout) E.U. Commission Directive 2003/94/EC (throughout) FDA Hazard Analysis Critical Control Point (throughout) ISO 15189:2012 (throughout) ISO/IEC 17025:2017 (throughout) OECD GLP Principles 8 USDA Administrative Procedures for the PDP (throughout) USDA Data and Instrumentation for PDP (throughout) USDA Sample Processing and Analysis Procedures for PDP (throughout) WHO Technical Report Series, #986, Annex 2 (throughout) The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.

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