FDA Inspection Feedback

Hi Guys,

 

We just had intense FDA audit yesterday.

It took all day and there was no major violations but there were two minor issue he/she verbally discussed.

We did not get asked much about food safety plan while they were reviewing it.

 

I'm curious, how do you manage your SOPs approver's name/signature? Electronic signatures is okay for GFSI standard.

Is it true that FDA requires wet or fancy electronic signature that have date and time stamp? So we know that that person really signs it. 

 

It would be great if you guys can share your stories about your recent FDA visit/audit as well.

Hi Gracezy,

 

I have always used Microsoft Sharepoint to create a secure library of SOPs. Sharepoint is a website design suite available through the Office 365 software that most companies have. If you have access to MS Word and MS Excel, you likely already have Sharepoint. With this software you can create a library of files that is permissions-based, meaning only certain users have the ability to edit documents. Additionally, version history can be tracked within the software. You can tailor permissions on a user-by-user basis, meaning managers can view/edit/delete, while technicians can only read files. On the file/SOP itself, we have always done a simple electronic signature of the approver's name. Beyond this, an electronic signature acknowledgement form is kept on file for each person capable of signing documents. This system hasn't ever been a concern to any auditor I've shown it to.

 

The downside is...sharepoint can be weird to learn. Many aspects of it can be unintuitive. If you're interested, look up guides on how to create these concepts in sharepoint, in this order

 

- Sharepoint Startup

- Sharepoint Sites/Pages

- Adding Users/Permissions

- Creating Lists

- Creating Libraries

I’ve historically always kept a paper record of my FSQMS, with each *page* signed by the author of the program and the relevant approval signatures, then allow correct electronic versions to be distributed as needed. Signatures on each page are a huge pain to implement, but it removes all argument that the approver didn’t review each page, and once your program is well established it’s not super hard to keep it going.

As long as the paper photocopy that ends up somewhere matches your official bible in the manual, it’s been approved everywhere I go.

We too are moving towards a SharePoint based library to better control the electronic copies.

Not in USA but seems odd if a Signature is actually mandatory.

 

Personally, for all FSMA Documentation -

 

(1) Have never used a Signature Requirement.

(2) Master Computer/Location referenced as the Current Approved Source.

We have a master signature list on paper for the quirkie FDA inspectors and on the computer.

Interesting enough not one inspector has asked for it.

We have something like SQFconsultant suggests. We have the signature and initials of every person that 'signs off' on paperwork. Through the most scribbly hand writing, we can make the connection between that and a real person.

FDA has guidance around this already, but it is only guidance and nonbinding.  I've never encountered an issue with an inspector, including FDA, regarding digitally signed documents.  But, these are digitally signed PDF's that has a unique ID for whoever creates the PDF.  This is how we handle our documents in conjunction with use of sharepoint for permissions restrictions.  It works out well and no issues.

 

As someone else mentioned, sharepoint is quite powerful in terms of document trace, revision history, and document signing / security.  The downside is you need someone well versed in sharepoint to take use of all the tools it provides.  The upside is once you set it up it is self maintaining so long as the users follow the same process.

 

https://www.fda.gov/...and-application

FDA has guidance around this already, but it is only guidance and nonbinding.  I've never encountered an issue with an inspector, including FDA, regarding digitally signed documents.  But, these are digitally signed PDF's that has a unique ID for whoever creates the PDF.  This is how we handle our documents in conjunction with use of sharepoint for permissions restrictions.  It works out well and no issues.

 

As someone else mentioned, sharepoint is quite powerful in terms of document trace, revision history, and document signing / security.  The downside is you need someone well versed in sharepoint to take use of all the tools it provides.  The upside is once you set it up it is self maintaining so long as the users follow the same process.

 

https://www.fda.gov/...and-application

Thank you very much Ryan. I appreciate it. We are planning to use Adobe Sign Tools. Our current Adobe DC allows us to use Certified Signature. 

We have something like SQFconsultant suggests. We have the signature and initials of every person that 'signs off' on paperwork. Through the most scribbly hand writing, we can make the connection between that and a real person.

This is good suggestions. Thank you so much!

We have a master signature list on paper for the quirkie FDA inspectors and on the computer.

Interesting enough not one inspector has asked for it.

Yes, Glenn. I couldn't agree more with you on this!

Not in USA but seems odd if a Signature is actually mandatory.

 

Personally, for all FSMA Documentation -

 

(1) Have never used a Signature Requirement.

(2) Master Computer/Location referenced as the Current Approved Source.

It is very odd for me too!

Thank you Charles!

I’ve historically always kept a paper record of my FSQMS, with each *page* signed by the author of the program and the relevant approval signatures, then allow correct electronic versions to be distributed as needed. Signatures on each page are a huge pain to implement, but it removes all argument that the approver didn’t review each page, and once your program is well established it’s not super hard to keep it going.

As long as the paper photocopy that ends up somewhere matches your official bible in the manual, it’s been approved everywhere I go.

We too are moving towards a SharePoint based library to better control the electronic copies.

Thank you so much!

 I appreciate it. We are planning to use Adobe Sign Tools. Our current Adobe DC allows us to use Certified Signature. 

Hi Gracezy,

 

I have always used Microsoft Sharepoint to create a secure library of SOPs. Sharepoint is a website design suite available through the Office 365 software that most companies have. If you have access to MS Word and MS Excel, you likely already have Sharepoint. With this software you can create a library of files that is permissions-based, meaning only certain users have the ability to edit documents. Additionally, version history can be tracked within the software. You can tailor permissions on a user-by-user basis, meaning managers can view/edit/delete, while technicians can only read files. On the file/SOP itself, we have always done a simple electronic signature of the approver's name. Beyond this, an electronic signature acknowledgement form is kept on file for each person capable of signing documents. This system hasn't ever been a concern to any auditor I've shown it to.

 

The downside is...sharepoint can be weird to learn. Many aspects of it can be unintuitive. If you're interested, look up guides on how to create these concepts in sharepoint, in this order

 

- Sharepoint Startup

- Sharepoint Sites/Pages

- Adding Users/Permissions

- Creating Lists

- Creating Libraries

 Wow this is great! We have SharePoint yup. I appreciate it. We are planning to use Adobe Sign Tools. Our current Adobe DC allows us to use Certified Signature.