Quality Plan for eQMS software

[Qualitygirl]

Would anyone out there happen to have a Quality Plan Template for switching eQMS software? We are a Medical Device company and are compliant to 13485:2016 and 820. In the process of switching from one software to another. I have never done this before and am really curious if anyone had something that they used that helped make sure they were hitting all the necessary bases for a somewhat smooth transition.

 

[yodon]

That's going to be a challenge as there's a *lot* to consider! Do you have a plan of attack? I would (and probably other would also) be happy to look it over and see if anything might be missing / not considered. Do you already have a data migration strategy? Is the new vendor offering to help?

 

[QuinnM]

Hi Qualitygirl,

Your current eQMS should be validated, and the new eQMS will need to be validated. I would leverage the current validation, or the new eQMS company for the validations. I validated my own eQMS system and another time had the eQMS company validated for us (we performed the PQ). I felt the validation we purchased from the eQMS company was too extensive, and not risk based.

Also the FDA has a guidance document: "Computer Software Assurance for Production and Quality System Software"

Best regards,
Quinn