Initial Importer/Distributor and Software Validation

margadia

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I work for an Initial Importer/Distributor. We do not manufacture devices, we don't even actually receive or ship any of the devices, we import them from the manufacturer to a 3rd party logistics provided, FDA registered, and they receive in and ship out devices per our ordering system. The ordering system also houses our service requests, which is where we pull information RE: any complaints that come in. To be clear, our customers contact us directly via phone or email if they have any complaints to report, and this is then transcribed by an employee into a service request. The QM then goes through the service requests to determine what is a complaint vs what is for routine service (ex: request for consumable part, customer broke something and needs it replaced). We are not 9001 or 13485 certified, but we do have a Quality System in place. Are we required to validate this cloud based CRM? Your help is appreciated! Thank you.
 
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