|
Tags: Manual revert Replaced |
| (107 intermediate revisions by the same user not shown) |
| Line 7: |
Line 7: |
|
| |
|
| ==Sandbox begins below== | | ==Sandbox begins below== |
| | | <div class="nonumtoc">__TOC__</div> |
| ==12. Scheduled Event Management==
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-5-1]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.6–7]<br />
| |
| | style="background-color:white;" |'''12.1''' The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/212.61 21 CFR Part 212.61 (a)]<br />[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166 (b)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-5-2]
| |
| | style="background-color:white;" |'''12.2''' The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-5-3]
| |
| | style="background-color:white;" |'''12.3''' The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-5-4]
| |
| | style="background-color:white;" |'''12.4''' The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-5-5]
| |
| | style="background-color:white;" |'''12.5''' The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.
| |
| |-
| |
| |}
| |
| |}
| |
| | |
| ==13. Instrument Data Capture and Control==
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| |
| |-
| |
| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-6-1]
| |
| | style="background-color:white;" |'''13.1''' The system shall be able to trigger an instrument event after a definable number of uses of that instrument.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-6-2]
| |
| | style="background-color:white;" |'''13.2''' The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-6-3]
| |
| | style="background-color:white;" |'''13.3''' The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-6-4]
| |
| | style="background-color:white;" |'''13.4''' The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-6-5]
| |
| | style="background-color:white;" |'''13.5''' The system should be able to accept the results uploaded from an interfaced instrument.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-6-6]
| |
| | style="background-color:white;" |'''13.6''' The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-6-7]
| |
| | style="background-color:white;" |'''13.7''' The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP/IP, and USB.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-6-8]
| |
| | style="background-color:white;" |'''13.8''' The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.
| |
| |-
| |
| |}
| |
| |}
| |
