Questions on Technical File to show it is current

[katastic2908]

Good Afternoon,

I really just want to scream right now so I am hoping someone here can talk me off the ledge.

Ok, during our recent unannounced NB audit we were given a finding because the particular Tech File for the product they were observing during the audit wasn't up to date. What I mean is some of the controlled documents within the tech file had be revised and the tech file didn't have the most recent revisions and in the Tech File itself it referenced both the document number and revision of the applicable document.

Fine, I'll take my CAPA like a grown up. So I have been searching and searching the dark corners of the interwebs and can't find what I need.

So here are my questions and I would appreciate any links to guidance documents if you have any

1. Can the Tech File be a document that references other documents within our DMR and DHF that comprise the Tech file which can still be accessed onsite, or does the Tech File itself need to also contain copies of those documents at all times?

2. Does a Tech File need to have a revision history that would include descriptions of all of the changes made to the documents contained within the tech file? It seems redundant to be since each document has its own revision history.

depending on the responses I get I may have more follow up questions.

Thank you for taking the time to read and respond, I really do appreciate it.

 

[pkost]

In my mind the technical file is more of a concept than a file

The information that is required to be in a technical file must be accessible, but nothing says that that has to be in a single location such as a filing cabinet all in neat order. It could be multiple files spread out over the site.

A contents list of all required documents and their location is sufficient; I'd probably even go as far to say that the contents list doesn't need to list the versions if you can adequately show that your change control of a document adequately assessed and approved the affect on the product/file as a whole - the version your contents list points to will always be the current approved and this can be identified on that specific document

With regards to the change history, this forms part of the original sub document therefore is intrinsically part of the technical file, it doesn't need to be reproduced!

 

[somashekar]

Good Afternoon,

I really just want to scream right now so I am hoping someone here can talk me off the ledge.

Ok, during our recent unannounced NB audit we were given a finding because the particular Tech File for the product they were observing during the audit wasn't up to date. What I mean is some of the controlled documents within the tech file had be revised and the tech file didn't have the most recent revisions and in the Tech File itself it referenced both the document number and revision of the applicable document.

Fine, I'll take my CAPA like a grown up. So I have been searching and searching the dark corners of the interwebs and can't find what I need.

So here are my questions and I would appreciate any links to guidance documents if you have any

1. Can the Tech File be a document that references other documents within our DMR and DHF that comprise the Tech file which can still be accessed onsite, or does the Tech File itself need to also contain copies of those documents at all times?

2. Does a Tech File need to have a revision history that would include descriptions of all of the changes made to the documents contained within the tech file? It seems redundant to be since each document has its own revision history.

depending on the responses I get I may have more follow up questions.

Thank you for taking the time to read and respond, I really do appreciate it.

1. YES. No need to duplicate. This leads to your current situation.
2. NO. Again duplication. Your TF as a whole needs a revision control.

 

[pkost]

Deduplication is key!

 

[Pads38]

We maintain our Technical Files as ring-bound paper files.

Tech A has 6 sections, Tech B 13. The 'Contents' front page shows the issue number for each section along with the date and Change Note number of when it was last changed. The Change Note records details of the change.

For the sections that call for test specifications and for manufacturing drawings, both of which are part of the Device Master File, the TF just has a pointer. The Issue number of the Contents page is used as the Issue number of the entire file - this is recorded in the DMF.

(Strictly speaking the drawings and other parts of the DMF are part of the Tech Files rather than the other way around).

For the Instructions for Use it just has a pointer to a server location and a path that ends ...IfU-IssN, where N is the highest number available.

It actually works fairly painlessly, and having the entire TF available, in one easily referred to package was a definite benefit when it came to our unannounced audit. (One 'Minor')!

 

[hogheavenfarm]

"...What I mean is some of the controlled documents within the tech file had be revised and the tech file didn't have the most recent revisions and in the Tech File itself it referenced both the document number and revision of the applicable document..."

I simply refer to the documents (name/title) and instead of quoting the revision, I state "(current revision level)" so I do not have to scramble every time a referenced document is revised. Periodically I review the tech file and make any updates needed (if there is a major document change or new process). That's when I note in the revision matrix that I reviewed the file and date it, if there are changes it gets a new revision then.