LIMSpec/Statistical trending and control charts: Difference between revisions

Latest revision as of 15:04, 19 June 2024


Regulation, Specification, or Guidance	Requirement
21 CFR Part 820.250 AIHA-LAP Policies 2018 2A.7.7.1.3 ASTM E1578-18 E-10-1 EPA 815-R-05-004 Chap. IV, Sec. 7.2.8 EPA 815-R-05-004 Chap. VI, Sec. 7.8 E.U. Commission Reg. No. 2073/2005 Article 9 FDA Hazard Analysis Critical Control Point Principle 4 ISO/IEC 17025:2017 7.7.1	18.1 The system should allow authorized users to configure the generation of statistical trending and control charts.
21 CFR Part 820.250 AIHA-LAP Policies 2018 2A.7.7.1.3 ASTM E1578-18 E-10-2 EPA 815-R-05-004 Chap. IV, Sec. 7.2.8 EPA 815-R-05-004 Chap. VI, Sec. 7.8 E.U. Commission Reg. No. 2073/2005 Article 9 FDA Hazard Analysis Critical Control Point Principle 4	18.2 The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.

@@ Line 15: / Line 15: @@
 [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 7.8]<br />
 [https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02005R2073-20200308 E.U. Commission Reg. No. 2073/2005 Article 9]<br />
-[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 4]
+[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 4]<br />
+[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.7.1]
    | style="background-color:white;" |'''18.1''' The system should allow authorized users to configure the generation of statistical trending and control charts.
   |-