Thanks to everyone who joined us for our Automating Traceability and Documentation webinar. The recording is now available on YouTube
if you missed the webinar or want to watch it again. Q&A from the session follows.
Q&AHow likely is it for guidance systems to evolve over the development period of a particular device? Does a company have to go back to older data and documentation to meet newly instituted guidance later in the development cycle?
(Avellanet – Cerulean Associates) Here is the answer that the data gives since about 1980 or so. Number one, it is very frequent that a guidance associated with your type of device will be developed while you are in the process of developing your device. If I had to lay odds based on everything that I have seen, I would say you probably have a 99.9% chance of a guidance coming out. It may only be relevant to a small portion to your device or development, but there is simply no data to go back and say that this guidance came out and only impacted the labeling on this device as opposed to wholesale design changes, etc. To be conservative, I would say this is going to happen without question.
Here is the exception: if your device has some miraculous cloud appear and you can get it done in less than three to four months or even a year, from idea to actual submission, you may be able to escape having to meet newly instituted guidance. In general, from the moment you hear someone at the FDA say we should do this (such as at a conference), you have about a three-year window before you can expect that guidance to come out. The exception being the infamous social media guidance and the revisions to Part 11 compliance. If your device development through submission takes less than a year you have a good chance of not dealing with it.
Now, how likely is it that a company has to go back to older data and documentation and meet newly instituted guidances that are released late in the company’s device development? Essentially, you’re going to have to do the same thing that I did and everyone else has to do. You are going to have to take a calculated risk. And the risk is this: if it is a guidance document, let’s say something associated with current device safety impacting exactly what you are about to submit, you are kidding yourself if you think that FDA reviewers are not going to have been involved in at least helping to review that guidance. Therefore, they will be looking at your submission for adherence to those guidelines. If, however, it’s a guidance on early preclinical development activities and it came out long after you completed the early stages of development, then you have to make a risk assessment. You need to ask yourself how likely it is that the guidance will impact your submission to the FDA if you don’t tackle at least some elements of the guidance. I’m not saying go back and re-do tests. I’m suggesting, however, that you decide if you should we draw out elements of what you did way back when so you can show the FDA that you were thinking about this type of thing way back when. You have to make that risk judgment, and that’s the best you can do.
Is it possible to get a copy of the sample project used in the webinar?
(Nicholson – Seapine Software) The sample project will be available at the beginning of the year, in the TestTrack 2012 release. At that point, it will be included in TestTrack as a sample project that you can use..
What level of administration resources are required to manage a system like TestTrack?
(Nicholson – Seapine Software) Initially, you’ll need a few days for training and configuring TestTrack to match your business compliance processes.. Once those activities are completed, it depends on how much you want to tweak TestTrack or how much your development process is changing. TestTrack is easy to administer, and many companies don’t even need a full-time TestTrack administrator.
What operating systems does TestTrack support?
(Nicholson – Seapine Software) TestTrack supports Windows, Mac OS X, and Linux.
Can outside design partners and other third-party users access a TestTrack sections set up just for them?
(Nicholson – Seapine Software) Yes, using TestTrack’s comprehensive security groups, you could configure specific viewing capabilities with read-only access.
The FDA wants to see validation of software used in the quality system, how you can help us validate TestTrack?
(Nicholson – Seapine Software) We can provide assistance through our Professional Services team. We have also worked with other consultants and partners that do this for a living. It’s really your decision on how much involvement you need. We also provide reports out of TestTrack that assist with these documented validation efforts.
Should the Investigative Review Board (IRB) play a role in traceability and documentation?
(Avellanet – Cerulean Associates ) I assume that you are talking about the investigative review board in terms of clinical testing and design. I think in that concept, one of the things that we want to talk about is that you want to view the IRB almost as an outside design partner. Thus, their role would be really to just review design documents. I am not necessarily assuming or thinking that they are going to go in and do testing. Certainty no IRB that I have been associated with wants to do that. But they do want to review documents. Giving them read-only access to any type of automated system is a great way to go about it because what’s going to happen is they are going to create their own sets of internal IRB documentation.
You also want to be careful about including that internal IRB documentation in your design history file. In a lot of cases it’s not necessary and, if the agency has actual questions, they will ask you to provide the specific contact information for the IRB (and point them in that direction). So, let the IRB be responsible for their own documentation. The exception being once your device has been on the market for years, you may want to pull the actual records from the IRB and then incorporate it into a big archived design history file that goes into your archive history and stays there for its full retention period. If you want to make sure your FDA recordkeeping is appropriate, think about finding an outside expert in “FDA records management” or “FDA document retention” (those are good internet search terms).