Hi I am looking for a little guidance and perhaps a link

The company I work for has just gone through a "leaning" and the Prodcut Creation process has been redesigned and is about to go live.

previously Generation of Verification Plans, Risk Analysis, Investigations etc etc during the design of a a device all required a signature (hand written) and date.

The proposal now is to do away with this and just have the documents produced by the engineers and when all are agreed to move to next stage in design process go to a PSG (Product Steering Group) for approval to proceed to next stage.

This group will listen to product manager who will assure them that all documentation is in place and accurate, but there will be no signatures on these documents.... and the PSG will then allow the project to go to the next stage. This will be documented as an approval and will have signatures from PSG. And presumably (yet to be determined) this document will be filed with DHF???

I feel a little uneasy about this as without the project groups signatures the only assurance you have that its ready to go through formally is the Project Mgr's... and then the PSG's approval.

Is there any FDA regs or guidance detailing the Approval or Authorisation that must be present for design documents. I have looked at 820.30 (c) and (d) they talk about authorisation but not approval and are not specific as to where they would expect the sigs to be.

thx in advance for any help on this

Nigel :thanx:

Hi Nigel,

The requirements for signatures is an integral part of any GMP document and do not ever plan "lean" concept on this to prevent you getting in trouble.

FDA has clearly mentioned these signature requirements in the QSR Manual -
http://www.fda.gov/cdrh/qsr/03desgn.html

It clearly states -

Design Output Approval (3)


The third and final output requirement is that: design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented. This means that:

Manufacturers may choose to have a group review certain documents and have individuals review other documents.

Output documents that are directly part of the DMR are reviewed, dated and signed by the author which is current practice; and reviewed, dated and approved by individual(s) designated by the manufacturer. As appropriate, these reviews should cover technical issues as well as adequacy for use in production, purchasing, servicing, etc. DMR documents that are generated and approved under 820.30 automatically meet the approval requirements of 820.40, Document Controls and do not have to be re-approved under 820.40.

Design output reports, data and any other document that will be used to create documents in the DMR are reviewed, dated and signed by the author which is current practice; and reviewed, dated and approved by individual(s) designated by the manufacturer. Design output also includes the physical design which, of course, is not intended to be signed, and dated. The approval for the physical design is the validation that is done on initial production units.

Hope this clarifies.

Thx for the informative reply I am reading through the link you sent.

The crux is approval, is it a requirement that the individuals performing the review need to print, sign and date... or can it be taken by the PSG that the review has taken place as it is part of the project groups job/responsibility to do so, and the permission to move to the next phase would not be requested if they had not reviewed the docs therefore APPROVAL comes from PSG to proceed to next step and any other signatures are "waste".

I am not comfortable with this proposal but I need to show it is non compliant for the documents not have signature showing the documents have been reviewed.

I keep thinking about an old adage "if its not documented then it did not happen", the response I am getting is that because PSG has approved it has happened.

:argue: :bonk:

Once again thx for your response

I keep thinking about an old adage "if its not documented then it did not happen", the response I am getting is that because PSG has approved it has happened.

Absolutely. ;) :agree1:

I generally have all documents with 3 levels -

Prepared By: _________________ Sign and Date : ________________

Reviewed By: _________________ Sign and Date : ________________

Approved By: _________________ Sign and Date : ________________