Difference between revisions of "Template:LIMSpec/Sample management"
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[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25] | [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25] | ||
| style="background-color:white;" |'''2.11''' The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing. | | style="background-color:white;" |'''2.11''' The system shall allow samples, specimens, and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing. | ||
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| style="padding:5px; width:500px;" |[https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q1ar2-stability-testing-new-drug-substances-and-products FDA Q1A(R2)] | |||
| style="background-color:white; vertical-align: text-top;" |'''2.12''' The system should allow authorized users to create projects and research studies in the system—including, e.g., stability studies—and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study. | |||
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