Template:LIMSpec/Configuration management

Regulation, Specification, or Guidance Requirement ASTM E1578-18 S-1-1 APHL 2019 LIS Project Management Guidebook 32.1 The system shall provide tools to enter and manage user-configurable lookup or master data. ASTM E1578-18 S-1-2 32.2 The system shall allow authorized users to configure the specification limits for sample and instrument tests. 45 CFR Part 162.1002 USDA Sampling Procedures for PDP 6.3.2 32.3 The system shall allow system nomenclature to be configured to use specific data code sets—such as the International Classification of Diseases or the Healthcare Common Procedure Coding System—or mandated terminology to support regulatory requirements. ASTM E1578-18 S-1-3 32.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels. ASTM E1578-18 S-1-4 32.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits. 21 CFR Part 211.100 (b) 21 CFR Part 211.160 (a) 32.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records. 40 CFR Part 3.10 40 CFR Part 3.2000 ACMG Technical Standards for Clinical Genetics Laboratories C13.3 ASTM E1578-18 S-1-5 NIST 800-53, Rev. 5, AU-10 WHO Technical Report Series, #996, Annex 5, Appendix 1 32.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports. ASTM E1578-18 S-1-6 32.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing. ASTM E1578-18 S-1-7 32.9 The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure. ASTM E1578-18 S-1-8 32.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow. 21 CFR Part 211.68 APHL 2019 LIS Project Management Guidebook ASTM E1578-18 S-1-9 32.11 The system should allow authorized personnel to perform revision control of lookup or master data. ASTM E1578-18 S-1-10 APHL 2019 LIS Project Management Guidebook 32.12 The system should provide a means for importing lookup or master data. AIHA-LAP Policies 2022 2A.7.8.4 ASTM E1578-18 S-1-11 EPA ERLN Laboratory Requirements 4.11.6 USDA Data and Instrumentation for PDP 9.1 32.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data. ASTM E1578-18 S-1-12 32.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata. ASTM E1578-18 S-1-13 EPA ERLN Laboratory Requirements 3.2.6 EPA ERLN Laboratory Requirements 4.9.11 32.15 The system should provide a clear alert or notification upon entry of out-of-specification results. ASTM E1578-18 S-1-14 32.16 The system shall allow authorized personnel to update static and dynamic data. ASTM E1578-18 S-1-15 32.17 The system should allow workflow events and status changes to trigger one or more user-defined actions. ASTM E1578-18 S-1-17 CJIS Security Policy 5.7.1 NIST 800-53, Rev. 5, AC-6(1) NIST 800-53, Rev. 5, CM-7 32.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems. ASTM E1578-18 S-1-18 CAP Laboratory Accreditation Manual 32.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications. ASTM E1578-18 S-1-19 32.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones. 21 CFR Part 11.100 (a) ASTM E1578-18 S-1-20 E.U. Annex 11-14 NIST 800-53, Rev. 5, CM-5(1) WHO Technical Report Series, #996, Annex 5, Appendix 1 32.21 The system should support rules governing electronic records and electronic signatures in regulated environments. 7 CFR Part 331.11 9 CFR Part 121.11 10 CFR Part 20.2110 10 CFR Part 30.51 (c-1 21 CFR Part 11.10 (d) 21 CFR Part 211.68 42 CFR Part 73.11 45 CFR Part 164.308 A2LA C211 4.13.1.4 A2LA C211 5.4.7.2 AAVLD Requirements for an AVMDL Sec. 4.10.1.3–4 AAVLD Requirements for an AVMDL Sec. 5.4.4.1 ACMG Technical Standards for Clinical Genetics Laboratories C5.3 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1 ASTM E1492-11 4.2.4 ASTM E1578-18 S-1-16 ASTM E1578-18 S-1-21 CJIS Security Policy 5.5.2 CLSI QMS22 2.4.3 E.U. Annex 11-12 EPA 815-R-05-004 Chap. IV, Sec. 8.6 EPA 815-R-05-004 Chap. VI, Sec. 8.6 EPA ERLN Laboratory Requirements 4.1.14–15 EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14 ICH GCP 2.10 ISO/IEC 17025:2017 4.2.1 ISO/IEC 17025:2017 7.11.3 NIST 800-53, Rev. 5, CM-5 and CM-5(1) NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards PFP Human and Animal Food Testing Laboratories Best Practices Manual TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4 USDA Administrative Procedures for the PDP 5.2.4 WADA International Standard for Laboratories (ISL) 5.2.3.5 WHO Technical Report Series, #986, Annex 2, 15.9 32.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions. BRC GSFS, Issue 8, 3.2.1 BRC GSFS, Issue 8, 3.3.1 CJIS Security Policy 5.5.2.2–3 EPA ERLN Laboratory Requirements 4.1.14–15 NIST 800-53, Rev. 5, AC-2(11) 32.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information. ASTM E1578-18 S-1-22 NIST 800-53, Rev. 5, IA-2(10) 32.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data. 21 CFR Part 11.200 (a) 45 CFR Part 164.312 45 CFR Part 170.315 (d) APHL 2019 LIS Project Management Guidebook ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1 ASTM E1578-18 E17-5 and S-3-1 CJIS Security Policy 5.6.1 CLSI QMS22 2.4.2.2 E.U. Annex 11-14 EPA 815-R-05-004 Chap. IV, Sec. 8.6 EPA 815-R-05-004 Chap. VI, Sec. 7.6 EPA 815-R-05-004 Chap. VI, Sec. 8.6 EPA ERLN Laboratory Requirements 4.9.4 ISO 15189:2012 5.10.3 NIST 800-53, Rev. 5, AC-2(7) and AC-3 NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8 NIST 800-53, Rev. 5, MA-4 WADA International Standard for Laboratories (ISL) 5.2.3.5 WHO Technical Report Series, #986, Annex 2, 15.9 WHO Technical Report Series, #996, Annex 5, Appendix 1 32.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user. 21 CFR Part 11.300 (a) ASTM E1578-18 E17-5 and S-3-1 EPA 815-R-05-004 Chap. IV, Sec. 8.6 EPA 815-R-05-004 Chap. VI, Sec. 8.6 ISO 15189:2012 5.10.3 NIST 800-53, Rev. 5, IA-4 and IA-5 32.26 The system shall prevent the same combination of identification components from being used across more than one account. 21 CFR Part 11.300 (b) ASTM E1578-18 E17-5 and S-3-1 CLSI QMS22 2.4.2 ISO 15189:2012 5.10.3 NIST 800-53, Rev. 5, IA-5 and IA-5(1) 32.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password. CJIS Security Policy 5.6.3.1 NIST 800-53, Rev. 5, AC-2(3) NIST 800-53, Rev. 5, IA-4 and IA-5(1) NIST 800-53, Rev. 5, PS-4 32.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived. CJIS Security Policy 5.5.2.2 NIST 800-53, Rev. 5, AC-10 32.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user. CJIS Security Policy 5.5.4 NIST 800-53, Rev. 5, AC-8 32.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., "you are accessing a restricted information system," "system use indicates consent to being monitored, recorded, and audited") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user. 21 CFR Part 11.300 (d) 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 A2LA C211 4.13.2.1 ASTM E1578-18 E17-5 and S-3-1 CAP Laboratory Accreditation Manual CJIS Security Policy 5.4.1.1 CLSI QMS22 2.4.4 E.U. Commission Directive 2003/94/EC Article 9.2 ISO 15189:2012 5.10.3 NIST 800-53, Rev. 5, CM-5(1) WADA International Standard for Laboratories (ISL) 5.2.3.5 WHO Technical Report Series, #986, Annex 2, 15.9 32.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings. 21 CFR Part 11.300 (d) ASTM E1578-18 E17-5 and S-3-1 CJIS Security Policy 5.5.3 ISO 15189:2012 5.10.3 NIST 800-53, Rev. 5, AC-7 32.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out. 21 CFR Part 11.200 (a) ASTM E1578-18 S-3-1 32.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session. 7 CFR Part 331.11 9 CFR Part 121.11 21 CFR Part 11.200 (a) 21 CFR Part 211.68 (b) 21 CFR Part 211.188 (b-11) 21 CFR Part 211.194 (a-7 and a-8) 21 CFR Part 212.50 (c-10) 42 CFR Part 73.11 ASTM E1578-18 S-3-1 CJIS Security Policy 5.6.3.2 NIST 800-53, Rev. 5, IA-5 32.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed. 7 CFR Part 331.11 9 CFR Part 121.11 21 CFR Part 11.10 (d) 42 CFR Part 73.11 42 CFR Part 493.1231 45 CFR Part 164.308 45 CFR Part 164.514 45 CFR Part 170.315 (d) ASTM E1578-18 S-1-25 CJIS Security Policy 5.5.1 EPA ERLN Laboratory Requirements 4.1.14–15 NIST 800-53, Rev. 5, AC-3 NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8 32.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both. 21 CFR Part 11.100 (a) 45 CFR Part 164.312 ASTM E1578-18 S-1-24 E.U. Annex 11-14 NIST 800-53, Rev. 5, AU-10 and AU-10(3) WHO Technical Report Series, #996, Annex 5, Appendix 1 32.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account. 21 CFR Part 11.100 (a) ASTM E1578-18 S-1-24 NIST 800-53, Rev. 5, AU-10 and AU-10(3) 32.37 The system shall prevent the reuse or reassignment of a user's electronic signature. 21 CFR Part 11.50 E.U. Annex 11-14 32.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record. ASTM E1578-18 S-1-26 APHL 2019 LIS Project Management Guidebook CLSI QMS22 2.8.5.3 WHO Technical Report Series, #996, Annex 5, Appendix 1 32.39 The system should provide a means to migrate static data into the system. NIST 800-53, Rev. 5, IA-5(1) CLSI QMS22 2.4.2 32.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user. NIST 800-53, Rev. 5, IA-6 32.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.