More than 35% of FDA warning letters cite poor record and document controls. And in the first part of 2012, FDA cited five companies just for poor recordkeeping of regulatory records:
Ningbo Huahui Medical Instruments
Campania Internacional de Comercio
Health One Pharmaceuticals
Edge Biologicals
Gulf Pharmaceuticals
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
Ningbo Huahui Medical Instruments
Campania Internacional de Comercio
Health One Pharmaceuticals
Edge Biologicals
Gulf Pharmaceuticals
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
