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Software Validation in Accredited Laboratories

Software Validation in Accredited Laboratories. A Practical Guide Greg Gogates Fasor Inc. gdg@fasor.com 26 Sept 2001. A copy of this paper will be maintained on ftp.fasor.com/pub/iso25/validation/. Preamble. ISO guide 25 “Adequate for Use” ISO 17025 “Suitably Validated”

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Software Validation in Accredited Laboratories

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  1. Software Validation in Accredited Laboratories A Practical Guide Greg Gogates Fasor Inc. gdg@fasor.com 26 Sept 2001 A copy of this paper will be maintained on ftp.fasor.com/pub/iso25/validation/

  2. Preamble • ISO guide 25 “Adequate for Use” • ISO 17025 “Suitably Validated” • Validation - Reasonable Assurance • Maintain Design Control • Know what's where! • Keep it Simple • EA/GA(98)95 Draft“EA Guidelines for the use of Computers and Computer Systems in Accredited Laboratories” NCSL Presentation

  3. Software Classifications • COTS - Commercial Off the Shelf • MOTS - Modified Off the Shelf • CUSTOM - Written from scratch NCSL Presentation

  4. COTS • Use as delivered • No modifications/customizations • Verify functionality • Verify menu contents • Verify parameter files • Lock down changes • Installation checkout NCSL Presentation

  5. MOTS • Needs configuration/customization prior to use. • Customizations require validation. • Non-modified portion treated as COTS • Installation checkout. NCSL Presentation

  6. CUSTOM • Home Brew or Consultant code • Functional Requirements • Software Design • Traceability Matrix • Structural / Functional Tests • Installation Checkout NCSL Presentation

  7. Software Life Cycle NCSL Presentation

  8. Products / Systems NCSL Presentation

  9. Software Configuration Management • What software is on what machine • Store originals on Network Share, Tape, or CD-R • Maintain all published versions • Control Access • Ensure user access NCSL Presentation

  10. Documentation Configuration Management • Evidence of validation • Evidence of adequate for use • Owners / User manuals • Software Lifecycle documents • Test Evidence NCSL Presentation

  11. Good Practices - 1 • Treat each software product a piece of calibration equipment. • Do checks to ensure nothing changes. • Place software product masters in a read only directory. • Network computers that access a shared program on a server. NCSL Presentation

  12. Good Practices - 2 • Lock spreadsheet cells that contain math. • Password protect configuration files or setup screens. • Backup, back-up, and backup off site! • Plan for hardware/software disaster recovery. • Good information maintained @ ftp://ftp.fasor.com/pub/iso25/validation NCSL Presentation

  13. Software Checklist - 1 • Has the Firmware been validated via the calibration by a cal lab who has the capability to thoroughly check the software (i.e. OEM or Authorized partner) (Note: for non-calibratable device Firmware, treat as Software) • Have all of the "used" firmware parameters been documented and confirmed that they are correct? • Does a Software Requirements document exist for the Software? • Does a Software Design document exist detailing either the full design or details of the configuration? • Does software testing documents exists describing completed, unique, test cases that exercise the design both +/- and confirms the requirements? • Is there a test log showing test failures and corresponding retests/dispositions? • Does evidence exist confirming correct software deployment at each target installation? [5.5.11] NCSL Presentation

  14. Software Checklist - 2 • Has configuration control been applied to all of their Software/Firmware to ensure that: [4.12.1.4] • The Software source code location is access controlled. [5.4.7.2.b] • Firmware/Software formulas & parameters are "locked" to prevent inadvertent changes. [5.5.12] • Equipment lists identify Software as a separate line item showing correct version and location. [5.5.5] • Does evidence exist showing that personnel involved in Custom Software development have adequate training? • Do Databases and spreadsheets include "audit trails" to not allow previously data to be obscured? [4.12.2.3] • Do adequate instructions exist for the operation & maintenance of the Software? [5.4.1] • Does the accuracy of the Firmware/Software meet or exceed the accuracy required by the test method? [5.5.2] NCSL Presentation

  15. S U M M A R Y NCSL Presentation

  16. QUESTIONS? http://www.sfgate.com/sf/zippy/ NCSL Presentation

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