G
Gumby24
Hi,
A friend works for an organization and he asked for my opinion in an area that I'm not fully up on. They currently manufacture non-medical products but they're at the point now of seriously considering the idea to start manufacturing a medical device.
I asked a few questions and their ERP system runs the entire business from sales order, procurement, materials management, kitting to product control and release. Validating that system would seriously constrain their main business and he wanted to know if there was a way to use their ERP system and supplemented with a paper system?
The device will use a paper based DHR and the final product will be declared into an ERP once it is complete.
The question I have relates to running the rest of the business from an unvalidated computer system. Is this possible and acceptable in the eyes of the regulators? They were told by an 'expert' they can use the ERP system to manage all of the above activities but view it as an editor where they use the system, print out the paper then simply sign and date the paper to make it a valid record.
This approach seems odd to me and I'm interested for comments if they would pass regulatory inspections with an unvalidated computer system which is used in this manner?
I'd appreciate independent input if this is proper or not? I have my own assessement but thought I'd ask in the event that I may have missed something.
Thanks in advance for any input.
A friend works for an organization and he asked for my opinion in an area that I'm not fully up on. They currently manufacture non-medical products but they're at the point now of seriously considering the idea to start manufacturing a medical device.
I asked a few questions and their ERP system runs the entire business from sales order, procurement, materials management, kitting to product control and release. Validating that system would seriously constrain their main business and he wanted to know if there was a way to use their ERP system and supplemented with a paper system?
The device will use a paper based DHR and the final product will be declared into an ERP once it is complete.
The question I have relates to running the rest of the business from an unvalidated computer system. Is this possible and acceptable in the eyes of the regulators? They were told by an 'expert' they can use the ERP system to manage all of the above activities but view it as an editor where they use the system, print out the paper then simply sign and date the paper to make it a valid record.
This approach seems odd to me and I'm interested for comments if they would pass regulatory inspections with an unvalidated computer system which is used in this manner?
I'd appreciate independent input if this is proper or not? I have my own assessement but thought I'd ask in the event that I may have missed something.
Thanks in advance for any input.