Procedure for Software QA

1 Page 1 GLP 15 – 2019 Page 1 of 11 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR.8250 GLP 15 Good Laboratory Practice for Software Quality Assurance 1 Introduction This is the metrology labor... Open at page → 2 Page 2 GLP 15 – 2019 Page 2 of 11 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR.8250 The Quality Manager/Laboratory Director is responsible for ensuring that this Standard Administrative Pro... Open at page → 3 Page 3 GLP 15 – 2019 Page 3 of 11 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR.8250 practices. The modification and use of COTS spreadsheets in the laboratory are considered software engine... Open at page → 4 Page 4 GLP 15 – 2019 Page 4 of 11 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR.8250 This phase develops, documents, and reviews a design that satisfies the requirements previously documente... Open at page → 5 Page 5 GLP 15 – 2019 Page 5 of 11 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR.8250 Where the software is developed by someone else, for example, configuration of COTS software, the final u... Open at page → 6 Page 6 GLP 15 – 2019 Page 6 of 11 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR.8250 Table 1. Validation Methods and Example Assessments. Validation Method Descriptions Evidence A Software i... Open at page → 7 Page 7 GLP 15 – 2019 Page 7 of 11 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR.8250 Validation Method Descriptions Evidence E Component testing Components include things like Pass/Fail test... Open at page → 8 Page 8 GLP 15 – 2019 Page 8 of 11 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR.8250 Validation Method Descriptions Evidence H Back-to-back testing Data that is published in an SOP, generate... Open at page → 9 Page 9 GLP 15 – 2019 Page 9 of 11 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR.8250 Appendix A Software Verification and Validation Form Laboratory: Date: Software Description: Version: Cod... Open at page → 10 Page 10 GLP 15 – 2019 Page 10 of 11 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR.8250 Codes Assessment Pass/Fail Result/Observations (Attach Evidence or Describe) C. Code Review The formulae... Open at page → 11 Page 11 GLP 15 – 2019 Page 11 of 11 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR.8250 Codes Assessment Pass/Fail Result/Observations (Attach Evidence or Describe) G. Embedded Data Evaluation... Open at page → 12 Page 12 This page is intentionally blank. This publication is available free of charge from: https://doi.org/10.6028/NIST.IR.8250 Open at page →