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ISO 13485:2016 - Validate our use of software that impacts on the QMS
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ISO 13485:2016 - Validate our use of software that impacts on the QMS
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  Post Number #9  
Old 10th August 2018, 09:47 AM
yodon

 
 
Total Posts: 1,158
Re: ISO 13485:2016 - Validate our use of software that impacts on the QMS

Short answer is yes.

FDA has posted this: https://www.fda.gov/downloads/scienc.../ucm092179.pdf

Section 4.5.3 talks about spreadsheet validation and provides a good overview:

General guidance for design and validation of in-house spreadsheets and other numerical
calculation programs includes the following considerations:
• Lock all cells of a spreadsheet, except those needed by the user to input data.
•Make spreadsheets read-only, with password protection, so that only authorized users can alter the spreadsheet.
•Design the spreadsheet so that data outside acceptable conditions is rejected (for example, reject non-numerical inputs).
•Manually verify spreadsheet calculations by entering data at extreme values, as well as at expected values, to assess the ruggedness of the spreadsheet.
•Test the spreadsheet by entering nonsensical data (for example alphabetical inputs, <CTRL> sequences, etc.).
•Keep a permanent record of all cell formulas when the spreadsheet has been developed. Document all changes made to the spreadsheet and control using a system of version numbers with documentation.
•Periodically re-validate spreadsheets. This should include verification of cell formulas and a manual reverification of spreadsheet calculations.
Thanks to yodon for your informative Post and/or Attachment!

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