Source: https://www.lablynx.com/healthcare/?rdp_we_resource=https%3A%2F%2Fwww.limswiki.org%2Findex.php%2FUser%3AShawndouglas%2Fsandbox%2Fsublevel12
Timestamp: 2020-06-02 14:00:39
Document Index: 573306941

Matched Legal Cases: ['art 1910', 'art 1910', 'art 1910', 'art 1910', 'art 820', 'art 493', 'art 331', 'art 121', 'art 211', 'art 1910', 'art 73', 'art 121', 'art 11', 'art 58', 'art 225', 'art 226', 'art 226', 'art 820', 'art 1910', 'art 1910', 'art 1910', 'art 1910', 'art 73', 'art 493', 'art 493', 'art 164', 'art 164', 'art 331', 'art 121', 'art 11', 'art 11', 'art 58', 'art 73', 'art 493', 'art 211', 'art 211', 'art 211', 'art 211', 'art 211', 'art 170', 'art 493', 'art 164', 'art 493']

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1 Sandbox begins below
2 8. Resource Management
3 9. Compliance Management
Sandbox begins below
Regulation, Specification, or Guidance
29 CFR Part 1910.120
29 CFR Part 1910.134 (m)
29 CFR Part 1910.1030 (h-1)
29 CFR Part 1910.1450 (j)
CJIS Security Policy 5.2.3
EPA ERLN Laboratory Requirements 4.2.4.1
EPA QA/G-5 2.1.8
USDA Administrative Procedures for the PDP 6.1
USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3
8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.
21 CFR Part 820.198
42 CFR Part 493.1233
E.U. Commission Directive 2003/94/EC Article 13
WHO Technical Report Series, #986, Annex 2, 2.1 (j)
WHO Technical Report Series, #986, Annex 2, 5.0
8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.
7 CFR Part 331.15
9 CFR Part 121.15
21 CFR Part 211.25
29 CFR Part 1910.1450 (f)
42 CFR Part 73.15
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3
ASTM E1578-18 E-1-1
CJIS Security Policy 5.2.1
FDA Hazard Analysis Critical Control Point Guidelines
USDA Sampling Procedures for PDP 6.1.2–3
WHO Technical Report Series, #986, Annex 2, 10
8.3 The system shall allow training sessions to be scheduled for personnel.
ABFT Accreditation Manual Sec. B
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7
ASTM E1578-18 E-1-2
8.4 The system should provide access to relevant training materials to personnel attending training sessions.
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
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5
ASTM E1578-18 E-1-3
E.U. Commission Directive 2003/94/EC Article 7.4
[ISO 15189:2012 5.1.9
WHO Technical Report Series, #986, Annex 2, 2.1 (e)
WHO Technical Report Series, #986, Annex 2, 9.4
8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.
ASTM E1578-18 E-1-4 8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.
ASTM E1578-18 E-1-5 8.7 The system should be able to produce a training matrix of personnel.
9 CFR Part 121.10
21 CFR Part 11.10 (i)
21 CFR Part 58.29
21 CFR Part 225.10
21 CFR Part 226.10
21 CFR Part 226.40
21 CFR Part 820.25
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 (e)
42 CFR Part 73.10
42 CFR Part 493.43 (c)
42 CFR Part 493.1235
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
AIHA-LAP Policies 2018 (various parts)
ASTM E1578-18 C-3-5
ASTM E1578-18 D-1-6
ASTM E1578-18 E-1-6
E.U. Annex 11-2
EPA 815-R-05-004 Chap. III, Sec. 10 and 17
EPA 815-R-05-004 Chap. IV, Sec. 1
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
8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
9. Compliance Management
7 CFR Part 331.17
9 CFR Part 121.17
21 CFR Part 11.10 (e)
21 CFR Part 11.70
21 CFR Part 58.130 (e)
42 CFR Part 73.17
42 CFR Part 493.1251 (d)
ASTM E1578-18 C-4-7
ASTM E1578-18 E-2-1
EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7
E.U. Annex 11-9
E.U. Annex 11-14
OECD GLP Principles 8.3.5
USDA Data and Instrumentation for PDP 8.1.3
9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.
21 CFR Part 211.68
21 CFR Part 211.100
21 CFR Part 211.160 (a)
21 CFR Part 211.188
21 CFR Part 211.194
45 CFR Part 170.315 (d)
ASTM E1578-18 E-2-2
CJIS Security Policy 5.4.1.1
CJIS Security Policy Appendix G.5
E.U. Annex 11-12.4
E.U. Commission Directive 2003/94/EC Article 9.2
WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9
9.2 The system shall document in the audit trail any event—including administrative and privileged functions—that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.
42 CFR Part 493.1274
ASTM E1578-18 E-2-3
USDA Data and Instrumentation for PDP 8.1.4
9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.
ASTM E1578-18 E-2-4
EPA ERLN Laboratory Requirements 4.8.6
9.4 The system's audit trail shall document the previous and current value of a modified field.
45 CFR Part 164.310
ASTM E1578-18 E-2-5
9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.
E.U. Annex 11-14 9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.
42 CFR Part 493.1274 (d)
9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.
source: https://www.limswiki.org/index.php/User:Shawndouglas/sandbox/sublevel12