FDA required (mandatory) Signed Records

Hello,

We are a medical device manufacturer and we are going to submit o 510k for our device.

Until now, we are a using a document management tool to store our documents and an issue management tool to handle CAPAs, non conformities and complaints.

Because these tools are not 21 cfr 11 complaint, we are going to prepare a printed version of everything. Is there a list of mandatory records that has to be printed and signed?

Thanks in advance for your help,
Dionysis

cGMP is the one that details the list of documents and records to be maintained by the manufacturer.
The difficulty is that your corresponding documents and records are not necessarily 1 to 1 equivalent, you may have multiple documents for one particularaly expected document or record.
So to job is to look for documents in the cGMP and records, determine based on cGMP whether or not signature is needed, than line up the records and documents you maintain to see the correlations and than you will have a proper list of documents and records expected to be signed.

Silent advice ... if your last design change record would lists all the documents that relates that particular commercial-final design than you can save a lot of signatures.

The QMS itself (till the extent of the cGMP) also contributes to the list of things to be signed.

That's the kind of situation when you may hesitate to thank or curse the one giving answers to your question though

Cheers!