Template

LIMSpec/Scheduled event management: Difference between revisions

(Created as needed.)
 
m (3 revisions imported: Importing my work from LIMSwiki, using the same CC license)
 
(2 intermediate revisions by the same user not shown)
Line 8: Line 8:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
   ! 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="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/part-129 21 CFR Part 129.80 (g)]<br />[https://www.astm.org/e1578-18.html 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]
   | style="background-color:white;" |'''12.1''' The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.
   | 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="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/e1578-18.html 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="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="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html 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="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="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html 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="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="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html 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.
   | 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.
  |-  
  |-  
|}
|}
|}
|}

Latest revision as of 14:03, 19 June 2024

Regulation, Specification, or Guidance Requirement
21 CFR Part 129.80 (g)
ASTM E1578-18 E-5-1
USDA Sampling Procedures for PDP 5.6–7
12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.
21 CFR Part 212.61 (a)
21 CFR Part 211.166 (b)
ASTM E1578-18 E-5-2
12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.
ASTM E1578-18 E-5-3 12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.
ASTM E1578-18 E-5-4 12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).
ASTM E1578-18 E-5-5 12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.