Dear all

Can anyone help me with the question of what physical form the above records can take? Let me explain my situation to clarify the question. I would be most interested to hear form people who have been through an FDA audit.

During an audit, does the document register need to be in an electronic format or hardcopy? If in hardcopy; does the register need to be in format where the information is entered manually or it can be softcopy and printed when required?

Thank you
:thanx:

Welcome to the Cove! :bigwave:

Our DMR is an electronic document which can be printed upon request. The DHR is a compilation of production and quality records, etc. and it is in hard copy, since the forms are completed by the folks who do the jobs. Our DHFs may be a combination of hard copy records and electronic documents.

I hope this helps. :cool: