Healthcare

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6. Reporting

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 C-6-1 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
6.2 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
6.3 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 6.4 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

6.5 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 6.6 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
6.7 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)

6.8 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

6.9 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)

7.1 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)

7.2 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.

21 CFR Part 820.40 (a)
42 CFR Part 493.1251 (e)
AAVLD Requirements for an AVMDL Sec. 4.3
ASTM E1578-18 D-1-3
EPA 815-R-05-004 Chap. III, Sec. 11
EPA ERLN Laboratory Requirements 4.2.4.2
EPA QA/G-5 2.1.9
ISO 15189:2012 4.3
ISO 15189:2012 5.5.3
ISO 15189:2012 5.9.3
ISO/IEC 17025:2017 7.5.2
ISO/IEC 17025:2017 8.3.2
USDA Administrative Procedures for the PDP 5.5
WHO Technical Report Series, #986, Annex 2, 15.5

7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.
ASTM E1578-18 D-1-4 7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.

21 CFR Part 211.21 (c)
21 CFR Part 212.20 (c)
21 CFR Part 212.60 (c)
21 CFR Part 226.58 (e)
21 CFR Part 820.250 (b)
42 CFR Part 493.43 (c)
ASTM E1578-18 D-1-5
EPA 815-R-05-004 Chap. IV, Sec. 5
ISO/IEC 17025:2017 6.5
ISO/IEC 17025:2017 7.2.1.3
USDA Administrative Procedures for the PDP 8.4
WHO Technical Report Series, #986, Annex 2, 15.14

7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.

21 CFR Part 212.20 (c)
21 CFR Part 212.70 (b)
AAVLD Requirements for an AVMDL Sec. 5.4.2.4
ABFT Accreditation Manual Sec. G-12, -14, and -15
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4
EPA QA/G-5 2.2.4
ISO/IEC 17025:2017 7.2.2.1
USDA Administrative Procedures for the PDP 8.4
WHO Technical Report Series, #986, Annex 2, 4.11
WHO Technical Report Series, #986, Annex 2, 15.13

7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.

7 CFR Part 331.10
7 CFR Part 331.15
9 CFR Part 121.10
9 CFR Part 121.15
21 CFR Part 11.10 (i)
21 CFR Part 58.29
21 CFR Part 211.25
21 CFR Part 225.10
21 CFR Part 226.10
21 CFR Part 226.40
21 CFR Part 820.25
29 CFR Part 1910.134 (c)
29 CFR Part 1910.1030 (g-2)
29 CFR Part 1910.1030 (h-2)
29 CFR Part 1910.1200 (h)
29 CFR Part 1910.1450 (f)
42 CFR Part 73.10
42 CFR Part 73.15
42 CFR Part 493.43 (c)
42 CFR Part 493.1235
42 CFR Part 493.1251
45 CFR Part 164.308
45 CFR Part 164.530
AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6
AAVLD Requirements for an AVMDL Sec. 5.2
AAVLD Requirements for an AVMDL Sec. 5.4.2.2
AAVLD Requirements for an AVMDL Appendix 1
ABFT Accreditation Manual Sec. B
AIHA-LAP Policies 2018 (various parts)
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3
ASTM E1578-18 C-3-5
ASTM E1578-18 D-1-6
ASTM E1578-18 E-1-6
E.U. Annex 11-2
E.U. Commission Directive 2003/94/EC Article 7.4
EPA 815-R-05-004 Chap. III, Sec. 10 and 17
EPA 815-R-05-004 Chap. IV, Sec. 1
EPA QA/G-5 2.1.8
ISO 15189:2012 4.1.2.1
ISO 15189:2012 5.1.6
ISO 15189:2012 5.1.9
ISO/IEC 17025:2017 6.2.2
ISO/IEC 17025:2017 6.2.3
ISO/IEC 17025:2017 6.2.5
ISO/IEC 17025:2017 6.2.6
OECD GLP Principles 1.1.2
USDA Administrative Procedures for the PDP 6.1

7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
ASTM E1578-18 D-1-7 7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.
AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5
EPA ERLN Laboratory Requirements 4.10.6
7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.
AAVLD Requirements for an AVMDL Sec. 4.3.4 7.10 The system shall be capable of uniquely identifying documents created in and added to the system.

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