Medical Device Design Review Records Requirements

U

Udashka

#1
Hi everyone!

need your advice.

I represent a software outsourcing company and we are responsible for creation software medical device for our partner. We use an iterative approach to the development. That means that we identified the product features and take them one-by-one to define how they should be implemented. When we complete analysis of a feature (or a set of them), a review is conducted. This review involves representatives of all the involved functions, as well as an independent reviewers, and have all other attributes of a design review required by Quality System Regulations part 820. As a result we create a meeting minutes where participants and decisions made are documented, but we do not apply any digital signatures on them.

And my question is: will it be acceptable from the FDA stand point that we keep collecting the meeting minutes in the way we are doing it right now and then create a report that summarize all the reviews, will include all the meeting minutes as a attachment and this report only with the attachment will be approved electronically in the system compliant with Part 11?

How do you collect such records?

Thanks a lot in advance!
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
A quick "Bump". My Thanks in advance to anyone who can help with this one. Medical devices is out of my field of expertise.
 

v9991

Trusted Information Resource
#3
1) Without acknowledging(signing-off) the minutes; how do you demonstrate that they actually happen on time (when and where required)

2) Collating/Summarizing at the end of development maynot be acceptable if, you also schedule for 'release'/'integrated-build' at that specific point or you plan a release by grouping a set of requirements;

3) How do you handle the integration of modules/dependability and testing aspects; How are the follow-up activities completed; These aspects to be addressed in relevant SOPs.

4) doing electronically would be acceptable (given that its part-11 compliant)

note/Disclaimer :- I am not into devices but, am speaking based on couple of projects in that area of software design-development-roll-out for regulated markets.
 

Michael Malis

Quite Involved in Discussions
#4
Hi,

Keeping meeting notes is not enough because we need to document the elements of PD (product development), such as:

* What are the goals and objectives of this design and development?
* Who has the responsibilities for each phase of design and development?
* What are the Major goals (tasks) to be completed?
* What are the deliverables for each process and who is responsible?
* What is the overall plan (schedule/chart)?
* Do you need to make any Major "Go" or "No Go" decisions during the overall schedule?
* Did you identify independent reviewers for this process?

Please also see FDA guidance documents if you have any general questions.

Regards,
Michael
 
U

Udashka

#5
Michael,

But we have the items you listed covered by SOPs and a strategy for design reviews for a particular project is usually defined and documented in the Design and Development Plan that is created for each project. And these reviews really happen and are very fruitful. The attendees review from different perspectives (I mean develoment, testing, quality assurance, field engineers, marketing functions, etc.) what is going to be done, how it is planned to be realized, what may be affected and how it could be mitigated.

My question is more about how records must look like. Is it acceptable to have them created in the system non-compliant with part 11 during the desin phase and to compile a report in the part 11 compliant system at the end of the design phase, having it reviewed and approved by product manager, for example?
 

v9991

Trusted Information Resource
#6
My question is more about how records must look like. Is it acceptable to have them created in the system non-compliant with part 11 during the desin phase and to compile a report in the part 11 compliant system at the end of the design phase, having it reviewed and approved by product manager, for example?
If you stretch that a little bit, it is like saying, I will keep documenting the details as and when required(on a computer / notepad etc.,) and transform it into required records as per some compliant system and at the end --- sign it off as per SOP at the end point; From pure-compliance stand point, that would not be acceptable; (again for same reasons as cited above post!)
 
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Michael Malis

Quite Involved in Discussions
#7
I am in agreement with v9991, - it is not acceptable from documentation and compliance.
Any auditor will look for records, not just the summary memo at the end of process!
 

yodon

Staff member
Super Moderator
#8
Not sure I'm ready to agree with everyone else just yet.

What part of the regulation would these records satisfy?

Let's say for the sake of discussion that you intend to satisfy the design review requirement of the regulation. The regulation requires:

The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).


I'm not aware of anything that requires design reviews to be approved (by signature).
 

v9991

Trusted Information Resource
#9
YOdon, that is not so interesting logic; If thats found to be acceptable/feasible, then lot of controls/documentation can be simplified/done-away;


The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).
While That is valid/logical line of thought; But, that is sort of control you would expect from system-control. Because, it is required in order to establish the compliance(validity or authenticity) & trace-ability;
It is particularly relevant when u walk into an organization which produces multiple product lines (& multiple versions and not to forget multiple teams(attrition - time); (further, once, a piece is missed to be documented; there's little-way to go back and recap the details)


I'm not aware of anything that requires design reviews to be approved (by signature).


Consider an hypothetical situation here, for eg., for requirements, risk assessment, marketing approval etc.,;

stretch this logic to manufacturing you could potentially simplify the documentation activities of training, in-process checks etc.,.

we ought to be trained on cGMP twice an year..., is it adequate for a person to sign off the record/attendance at the end of year. (acknowledging that he has undergone 2 sessions?); (this is indirectly linked with maintaining training attendance register and training cards)

What about the need for performing in-process checks, I would perform-record; but sign off at the end of batch release; just acknowledging that its done. (sometimes there are multiple people who are involved at different time points of inprocess checks)
 

Michael Malis

Quite Involved in Discussions
#10
Not sure I'm ready to agree with everyone else just yet.

What part of the regulation would these records satisfy?

Let's say for the sake of discussion that you intend to satisfy the design review requirement of the regulation. The regulation requires:

The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).


I'm not aware of anything that requires design reviews to be approved (by signature).
Yodon,

Let me try to clarify.

In the first message (4), I was describing the overall planning process and in the second, the fact that the "design reviews must be timely documented" not approved by the manager after...
Are you in agreement with this?
 
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