Hello,
We are a small MD repair company with a paper based QMS. I wondered if we were concerned by the requirements related to IT validation. The only software we have are related to inventory or operations (from repair order to delivery to customer). Do we need to validate them and do we need to write a procedure on it. I wondered if we could use the risk assessment to justify that these software have a very low impact on product conformity.
Thank you in advance for your help!
Best regards,
We are a small MD repair company with a paper based QMS. I wondered if we were concerned by the requirements related to IT validation. The only software we have are related to inventory or operations (from repair order to delivery to customer). Do we need to validate them and do we need to write a procedure on it. I wondered if we could use the risk assessment to justify that these software have a very low impact on product conformity.
Thank you in advance for your help!
Best regards,