The ugly truth about FDA compliance is that the agency doesn't care what you say you did, FDA investigators only look at the records and documents you've kept. You cannot hope to pass an FDA inspection without the right records.
So what sort of recordkeeping policies do you need? What should be in your SOPs to allow crystal clear record generation and retention? How do you find out what you need to keep? And what do you do when FDA asks for records held by your supplier or stored in email or in archive?
So what sort of recordkeeping policies do you need? What should be in your SOPs to allow crystal clear record generation and retention? How do you find out what you need to keep? And what do you do when FDA asks for records held by your supplier or stored in email or in archive?
