ERP System Software Validation - ISO13485 2016 4.1.6

Jeffbbt

Starting to get Involved
#11
Thanks Jeff, I’ve done some more research had a look at ISO 80002-2 basically tells you how to validate your software (not applicable to us) and the application itself. You're right it is lengthy! The software is already validated by the company, and we are not modifying the software which greatly reduces our 'risk'. All we are doing is changing the workflows to suite our needs and therefore its more of a process validation and for this we have identified the following documentations:
  • Software requirements
  • Software validation plan
  • Validation protocols for tests
  • Overall report
  • Process for the above, including when to re-validate and change control of any workflows.
Does this sound about right?
Hi Fat Larry,

Sorry - missed your reply. It does sound about right though! I am assuming it has gone well. What Software did you end up going with?
 
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