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| Regulation, Specification, or Guidance
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Requirement
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| ASTM E1578-18 E-3-1
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10.1 The system should provide a means for tracking usage of laboratory equipment and instruments.
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| ASTM E1578-18 E-3-2
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10.2 The system shall provide a means for planning the use of and reserving equipment and instruments.
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| ASTM E1578-18 E-3-3
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10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.
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| ASTM E1578-18 E-3-4
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10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.
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| ASTM E1578-18 E-3-5
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10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.
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| ASTM E1578-18 E-3-6
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10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location.
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21 CFR Part 211.67–68
21 CFR Part 211.160 (b-4)
21 CFR Part 211.30 (b)
21 CFR Part 211.60 (e)
21 CFR Part 225.30 (b-4)
21 CFR Part 606.60
21 CFR Part 820.70 (g)
21 CFR Part 820.72
42 CFR Part 493.1252 (b-3)
42 CFR Part 493.1255
AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2
AAVLD Requirements for an AVMDL Sec. 5.5
ABFT Accreditation Manual Sec. E-20
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1
AIHA-LAP Policies 2018 2C.3.7–2C.3.10
ASTM E1578-18 E-3-7
EPA 815-R-05-004 Chap. IV, Sec. 7
EPA ERLN Laboratory Requirements 4.11.11–13
EPA QA/G-5 2.2.6–7
ISO 15189:2012 5.3.1.4
ISO/IEC 17025:2017 6.4.7
ISO/IEC 17025:2017 6.4.8
USDA Administrative Procedures for the PDP 5.2.4
USDA Data and Instrumentation for PDP 5.2
USDA Data and Instrumentation for PDP 6
WHO Technical Report Series, #986, Annex 2, 13.5
WHO Technical Report Series, #986, Annex 2, 16.23
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10.7 The system shall allow the configuration of calibration and maintenance frequency and time frames, with available intervals of days, weeks, months, and years.
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21 CFR Part 225.30 (b-4)
AAVLD Requirements for an AVMDL Sec. 5.5.9
ASTM E1578-18 E-3-8
WHO Technical Report Series, #986, Annex 2, 16.23
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10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date.
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21 CFR Part 211.160 (b-4)
ABFT Accreditation Manual Sec. E-21
ASTM E1578-18 E-3-9
ISO 15189:2012 5.3.1.5
ISO/IEC 17025:2017 6.4.9
WHO Technical Report Series, #986, Annex 2, 13.10
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10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.
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21 CFR Part 820.72 (b-2)
ASTM E1578-18 E-3-10
EPA ERLN Laboratory Requirements 4.11.11–13
EPA QA/G-5 2.2.6–7
ISO/IEC 17025:2017 6.4.8
WHO Technical Report Series, #986, Annex 2, 16.23
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10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.
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