--- title: "Product Spotlight - Google Drive as a Governed Part of Your eQMS" type: webinar-transcript publisher: Ketryx source: "https://fast.wistia.net/embed/iframe/8zc0p6i86c" content: auto-caption transcript, proper-noun corrected --- # Product Spotlight - Google Drive as a Governed Part of Your eQMS *Ketryx webinar — transcript of the recorded session.* [▶ Watch the recording](https://fast.wistia.net/embed/iframe/8zc0p6i86c) --- Start with introducing myself. I'm Carlton O'Neil. I'm a product manager at Ketryx. I've been with Ketryx for a few years in in various roles. I think most heavily prior to this, I was working, on the implementation side. I've worked with a lot of great customers, some some of which that are that are on our webinar here today. Worked in a variety of of different use cases, different regulated processes kind of across the SDLC and and beyond, into EQMS flows, post market survey post market surveillance activities. So learned a lot through that and and really helped me build on my experience where I was coming from Amgen, owning CAPAs, owning complain or owning nonconformances, and kind of really got into the the QMS workflows and and now built on that with my time with Ketryx to learn more about the SDLC workflows, learn more about medical devices and and best practices across the industry rather just within one company. And, yeah, I'm here today to show you the new Google Drive integration with Ketryx. I'll start with giving you a a very brief overview on what Ketryx is and how we think about things and the inspiration for for the Google Docs integration. And then I'll show it to you in in two key workflows. There's like I said, for anyone who was here when I was rambling at the beginning, there's kind of so many use cases that this very general feature is now covered. But I'll show you kind of the main two we set out to to help folks with, and then happy to take any questions if you have a particular use case you're interested in. I can definitely show you that as well. I'm happy to go off on on some tangents for, anything that someone is particularly interested in in this call. I mean and, of course, we have lots and lots of staff here at Ketryx. If if you really wanna dive deeper into this feature or any other feature you see here today, see how it can bring your team value, help your team move faster, help your team reduce the instances of inaccuracy in your process. You can always book some time with Ketryx, and we're happy to set up a a demo that shows you for your use case how we'd how we'd approach it. So I'll jump into, this insulin delivery, project here. I have a few projects, some managing hardware, some managing a system of systems, some managing, you know, specifically documents. The projects here in Ketryx are are very, very flexible. And you'll see in this project, I have a variety of different items. I have, an SOP, vulnerability impact assessment, and then kind of items that are coming from the six two three zero four compliant workflow, software items, test cases, requirements, all of my design controls are here on this change control board. These items are also coming from a variety of systems. At Ketryx, we want to allow you to interoperate across tools, to speed up your development cycle, also to make the documentation that is a result of your development cycle, more accurate. We, do not want folks to have to work in Git and kind of do the documentation twice once in Git, once in Word or Google Docs. The tool pulls in all these items from various systems. I have Git and Jira connected to this project and, of course, Google Docs. That's why we're all here. And this project is actually operating between those systems. So we're running the entire, life cycle, the entire process for our release, across Jira, GitHub, and Google Drive. And, of course, we connect with with many, many systems and have supported customers across many different tools, particularly very large customers who have who have lots and lots of tools and and teams that prefer one tool to another, and kind of resolving any tension there is because, you no longer have to pick. If if the engineering team wants to primarily work in GitHub, Ketryx is able to support that and give kind of the activity level views so that their work as they're doing it in GitHub, is being reflected in the documentation, and other teams have visibility into it. You know, even if they aren't familiar with GitHub, they're able to see that here's a test case coming from GitHub. Same with Jira, ADO, X-ray, TestRail, a lot of a lot of different tools. And ultimately, what we're able to do with these items is enforce compliant workflows, such as reviews and approvals, and also enforce some rules in the system such as traceability. And you can see here I have traceability matrix that's pulling these items from all these different systems and showing me where I'm missing coverage with a click of a button so that we have a real time traceability matrix. Ketryx is always syncing with those external systems, you know, on the scale of seconds. So throughout the work or throughout our our process that we need to do to to release, we're always able to see across Jira, Git, Google Drive, the status of our activities that we need to complete to release. And then the best part is once you finish these activities across these systems, the evidence is now within Ketryx because we're syncing all the evidence onto these items, and you can work through a release. And you can see we have release dashboard here. This is kind of the central place to look at the status of these activities. I have some milestones. I have kind of approval status for my items, a checklist, and even natural language telling me what I need to do next according to my process to release this version of my monolithic product here. Once you complete all those activities, of course, you're going to want to generate documents. It's the common interface for for compliance evidence. So it's, of course, what Ketryx will give you in the end. We can generate lots and lots of documents. You can see I have a very long list here spanning across vulnerability management workflows, cyber risk workflows, requirements management workflows. We we don't we won't have kind of evidence spread across different systems. You know, maybe our vulnerability report is living in a cybersecurity tool. Our requirements or system requirement specification is living somewhere else. Because Ketryx is connected everywhere, we're pulling it into a flat list, you know, maybe your entire DHF. Maybe your entire DHF plus some other evidence you produce, outside of that for certain certifications or as a part of your QMS. In this case, I'm even producing documents from those items that are both kind of EU and US. So I can have a version of my system requirement specification that's for the EU. Maybe that one includes some GDPR specific requirements and then also one, for the US. And this can break down as as many jurisdictions as you want. If you needed to go state by state, maybe for privacy laws, it's it's very easy to create these documents and then create these document variants. What we're here to show today is the Google Drive integration. So kind of the core use case here is we're able to automatically generate these documents. But oftentimes, just pulling the requirements out of the requirements management tool to make the system requirement specification, isn't all the information. You might wanna work collaboratively with the team. Or even just to review, you can open it in Google Docs, chat with the team in the comments, use all those collaboration features that we know and love. Maybe you have notifications set up for people mentioning you in comments or assigning you tasks in comments in Google Docs. All of those features become available by after we generate this document, we can kind of post it into Google Drive. So you'll see I have the system requirement specification. You'll see I have a Google Drive section here, and I can view this document in Google Drive. And it has all this information coming from Jira, from GitHub. You can see this is a system requirement that's coming from Jira in this case. And just like I said, all the normal Google Docs features that we know and love are available. Even Gemini, I think, which is a very interesting part of this. How can you integrate AI into your review workflow, maybe even just searching for a particular requirement very quickly? Of course, if it's in Google Docs, then you get access to to Gemini built in with this help me write feature and then, of course, also just with their AskGemini sidebar. So how does this work in the first place? Well, all you have to do is pick any document that's generated and you click create in G Drive. And in this case, it was a test plan. Ketryx says, okay. I'm working on it. I'm uploading it to G Drive. Ketryx will put it in a kind of project and version specific folder within a specified location in g drive, so it's nicely organized. In this case, it's going to go into a monolithic system version one dot one dot one dot o dot one folder. And, of course, it's gonna have the name test plan. And you can see it's a matter of seconds that it creates it in in docs. And now this generated test plan, you know, containing maybe test cases from X-ray or TestRail or both or Jira and GitHub all comes together into a Google Doc that, again, I can edit as if it's a Google Doc. And whenever I'm satisfied with with the result of what this document is looking like, I can always come back to Ketryx and load in changes. And this goes in both ways. So I can, you know, tell Ketryx to ingest now what is in Google Docs maybe after we made some suggestions and went through commenting and accepted those suggestions. And I can also say, hey. Whatever is in Ketryx now, maybe I generate a new version of the test plan because I've edited what's in the test plan. Let's apply those changes to that Google Doc where we were working. Okay. So that's kind of use case one. Instead of first and foremost, we're automatically generating this document, which is already a huge efficiency gain, and, we're bringing, value to your to your SDLC, by reducing the amount of duplicate documentation you're doing by pulling information directly from the source systems and generating artifacts you need to release. And then now on top of that, we're allowing you to post the document into Google Docs, work with your team there, use all the features you're familiar with. You probably will never have to train someone on how to use Google Docs such that your compliance artifacts are updated and syncing back into the system of record where you have the approval. And the second case here that I'll go over is for documents that are not generated from items coming from a system. You're going to have a lot of these documents. In this case, I'm gonna focus on EQMS documents, plans, policies, procedures, but, of course, you could have maybe an installation form that's, you know, filled out by a service provider by hand and then you're uploading or something, or, you know, maybe a certification that's coming from a notified body that you need to upload. In this case, I'll just focus on QMS documents, and you'll see I have plans, policies, and procedures. We'll focus on the procedures today. You can see that these documents have some status, and Ketryx has a type for them as well. And if I click into one of them, you'll see Ketryx is providing a preview of the document. It's this is one of our draft or example SOPs. It's pretty standard, good documentation practices document. Of course, we have the full history of this document and the ability to approve and assign approval to particular people. But this document is actually living in Google Drive. This is not some document that we've uploaded to Ketryx, a single copy. It's actually connected in real time to a Google Doc. And, again, just like with before with the documents that we were generating from items that are in the connected systems, you can use all of the Google Doc features that you're familiar with. And in this case, I'll just make a small change here. I'll say this, SOP applies to all manufacturing sites. And, of course, again, I can comment. I can, maybe tag my coworker, Kevin, and say, you know, can you verify that this is true? Maybe he comes in and he suggests with the with the suggestion feature, oh, no. I think this is, not including our our Puerto Rico facility, or, you know, whatever teammates need to to get involved can can use the normal collaboration features. Of course, again, you don't need to train anyone on Google Docs. We're now editing this SOP directly in Google Docs. And kind of the real value Ketryx is bringing here is we're not having to set up some approval workflow or review workflow that's completely separate from Google Docs. I know my time previously, I've had a lot of trouble with downloading a DocX record from Google Docs, uploading that to an EQMS system, and then the formatting going crazy, the document looking nothing like what it looked like when I was working on it in Google Docs because of that transfer step. And, of course, that transfer step just also takes time every single time I wanted to upload a new draft to the system of record so that I could go through review and approval, I was manually downloading, manually uploading. Because Ketryx is just pulling this directly from Google Drive at any time I want, I can click this sync button, and Ketryx is telling me, would or, you know, confirm that you would like to update this document, with what is currently in the source system, Google Drive in this case. And it's gonna and it says, this will create a new draft provision of this document in Ketryx. So instead of downloading in Google Docs, which we were editing in Google Docs because it's probably the best place to collaboratively edit, Downloading there, having it locally on my machine, and reuploading to, the EQMS, Ketryx says, okay. I'm just going to pull in whatever is there now. Are you, you know, is are you in the team who can all see the document, who have all commented, satisfied with what is there? Of course, there are no comments on this one, so it's probably a good sign. Maybe we've gone through commenting, assigning, and we've resolved all those comments. We're all happy with it. And all I need to do is click sync, click yes, and Ketryx is going to update this document. And you'll see we got a new record in the history here from today, just a few just a few seconds ago when I pressed that sync button, and the document is updated. Great. So lots of things you can do here with different types of documents. That's just kind of a high level. I will say to kind of take now one step further, Ketryx is an ecosystem that connects and pulls information from different tools. It also allows you to interoperate across those tools. And I'll highlight a kind of Jira and Google Drive connected workflow that's enabled by Ketryx, in this document management, project. So I have another Ketryx project. It has completely different item types. Again, a project is it it's not opinionated about what it's helping you do, other than allowing you to review and approve items, make traceability, and, fulfill all of your activities and automatically generate evidence. But it could be for any process, really. And we have customers that use Ketryx for many, many processes. I think probably twenty or twenty five unique processes at this point. And in this case, I'm managing a change order workflow in my EQMS system. So you can see I have Google Drive connected, and I also have Jira connected. So my change orders are living in Jira and, you know, could be ADO, could be Jira, could be another system. You know, it's whatever tool you wanna use as as the project management tool. We like Jira. We we use Kanban boards and sprints and and all those great features. And so I picked Jira in this case. And those are kind of the the ticket items, the change orders, the point in time, things I need to assign to somebody, I need to put a due date on, to drive work forward. And I'm actually able to take these items and connect them to the Google Drive documents. So the team can get assigned tickets in Jira and know, oh, I need to update this Google Drive document. And we also have the compliance traceability. Why did you update this Google Drive document? And then, of course, pull the new version and approve that in Ketryx. Oh, well, if I look at my traceability, it was because QMS thirty three, which was a change order, was assigned to Carlton on some day. And, you know, we can put some rationale in that ticket, and it was executed. And that's why we updated the document. Great. We have a we have a question here. I'll take that right now because I think we're on the perfect screen to talk about it. It's what's the difference in setup for these features? And I think this could be asking one of two questions. I'll just answer both really quickly. The first question it could be is about the Google Drive for these documents that are not being generated from external, information, in my case, kind of QMS documents, plans, policies, procedures, versus the release documents where I'm generating some information and posting it to Google Drive. The setup is is very, very similar. Ketryx has a concept of what is a document that's being generated versus what is a document that that you, are not generating from the information. And there's kind of just two different settings that says, would you like to make a Google Drive connection for the documents you're generating? You can say yes, and please put them in this location. And then the second setting is, would you like Ketryx to be looking in a particular Google Drive folder to be pulling in documents that you already have, like plans, policies, procedures. And you can say, yes. Please look at this location, and Ketryx will, you know, bring in the folders, all the folder structure, and all the documents that are in there. And then I think maybe the second question was about, how I said twenty or twenty five unique processes in Catchrix are already supported, kind of across our customer base today. The the setup for that is also very easy. It really just comes down to which item types you have in here, which views do you have in here, what are your approval workflows, and what are the activities you need to complete, and automatically generate evidence for as a part of whatever that process is. And we have, like I said, a huge team of people who think about processes and enabling processes with with efficient automate automated workflows that are more than happy to show you all the different things that that you can do within Ketryx with that flexibility. Wow. Another question that is perfect for the screen. The question is, can can Ketryx AI create change requests or orders for us automatically? Absolutely, it can. Just like all the other items in the system, you have Ketryx AI, the assistant here on the side, always available to you to help you, work on or search for items. You can see we have a lot of suggested actions here where you can search for particular things. But you can absolutely use this to help you create change orders if, you know, it's kind of hard to put into words what you wanna do or you have some context, maybe a new FDA guidance, and you just want to put that FDA guidance here and then say, hey. Look through all of my plans, policies, and procedures and suggest what might need to be changed by creating a change order. Ketryx can automatically create a change order, post that to Jira or whichever system you're using to manage those change orders, or maybe you're just managing them entirely within Ketryx and say, we should update s o p one in this way, these sentences, this section, this diagram based on the guidance because it's clear now that this SOP is no longer in alignment with with this guidance, which can, of course, really speed up those workflows. Okay. So let's jump into Jira and have a look at one of these items, and I'll show you what I mean by this interoperability between, Jira and Google Drive in this case. So this is just a normal Jira ticket. Again, could be ADO. It could be another system, wherever you like to do your project management. You can see I have a description of the change, a reason for the change, and an impact analysis. And, again, Ketryx AI can definitely help me write this if I have all the context I need or I just want to, idea vomit at it and have it kind of structure a very succinct description of what we need to do here. And then you'll see also Ketryx is providing with approvals for this change order. In this case, my rules are just the owner needs to approve, and Ketryx is also providing traceability. And this is really the key part of that of that interoperability. I have this change order here, and it is related to a particular SOP. Catchericks can also help suggest the AI, if you have a very large change order that's listing a lot of documents or maybe you're not even clear which documents, should be there. If you click this button, you'll have the ability to have AI help you make the relation. And, of course, if you already know the relation, it's easy enough to find it in the list. And, of course, you can search here as well. Once you make that connection, then this item appears here in the traceability widget. Kind of the key thing here is this is real time traceability that Ketryx is maintaining. It's maintaining it according to certain rules. I can't, add related policy and then add, I don't know, an installation or or servicing record or something. It's it's only gonna let me add policies. It's only gonna suggest policies to me. And this real time traceability provides me with the ability to jump over into the connected system. So I'm in Jira. I've been assigned this ticket. Maybe I've been given some due date. Maybe it has some priority, all those normal Jira features, time tracking, Kanban boards. And by making this connection, it makes it very easy for me to work on this item. It says update SOP o o one to align with new electronic record retention requirements. Well, where is SOP zero zero one? Ah, it's right here. I can jump over there, read through it, make my changes, use Gemini even to help me. I can use Gemini to reference that that change order I've been assigned. Maybe it focuses me on a certain section. And then once I'm done, I can move this to resolve. Just go through my normal, Jira workflow, whatever whatever workflow works best for your team. And then, of course, I can approve it and move it to finish. And just to highlight this idea of kind of using best in class project management tools to manage the change orders or whatever tickets you need to relate to documents, I set up this Kanban board, which is all of my change orders. I have an expedite swim lane that's the highest priority ones and then kind of everything else below. I'm a one person army here in in this project. You could see my face is on every single change order. But, of course, with Jira, you can have teams and maybe swim lanes by teams or epics that sort work into to different groups. And, ultimately, this is not, you know, just some random Jira project sitting off to the side that's disconnected from my development workflows, that's disconnected from my EQMS or wherever my documents are living. I'm able to work in Jira, which is a great tool for project management, and I'm able to connect these Jira items to Google Drive and Google Docs, which is, at least in my opinion, the greatest tool on earth for collaborative document editing. So instead of saying, hey. Come into the system. We have we have, project management, and we have document editing. We say, you know, use Jira for project management. It's phenomenal at that. Use Google Drive for collaborative editing. It's phenomenal at that. Ketryx will allow you to interoperate between those systems, automatically generate evidence, automatically enforce rules, and ultimately prove compliance in those workflows without having to sacrifice on the tooling that the team is using. Okay. I think that, really covers it. Again, this feature has just ballooned into so many use cases. I showed you two today, but we we've already implemented a lot with with different clients. So happy to take any questions on on specific, different types of use cases that folks are interested in after seeing this this feature. And and like I said, if, you'd like to dive in with a kind of solution expert on the Ketryx side to talk about your use case, We have lots and lots of people that think about process efficiency, automation, and using best in class tools in interoperable way to drive processes forward and make them more accurate. Kevin, great question. That is that is where we're going. At the moment, you have to navigate back to Ketryx to let me say the question so I'm not just talking so everyone's in context. The question is, if I'm editing Google Docs, is there a way is there any way from there to sync into Ketryx without going back into Ketryx? The answer at the moment is no, but that's certainly the direction we're headed. We are actually already have kind of a Chrome plugin that allows you to work interoperably with Ketryx in some of our other connected systems so that you can kind of open the side panel that has Ketryx information. That's the direction we would go with this integration as well. As we build more and more on it, as we have with our other integrations, you're able to open Ketryx without leaving Google Docs and then click, you know, sync this information back. Oh, another question from Kevin. A risk management matrix and how you link this to a requirements matrix. Great question. I will show you at a high level. This risk or this traceability matrix is kind of requirements down to specifications and then up the other side of the v for testing. This is actually kind of completely arbitrary. I have five columns here. I could have ten. This column has, requirements that are not of type use case. It could have requirements that are of specifically type system or whatever I would like. It's just a filter. And you can see in here, I actually have a ton of different views. And within Ketryx, you're able to see these kind of real time traceability views. I think for the risk management matrix and how you link it to a requirements matrix, I would definitely set up one of these views so that wherever those risks and requirements are living, we always have these checks to make sure that we're covering everything. And this actually, that one doesn't have enough info. But this will drive our our process forward. Whatever rules we have for requirement to risk traceability, we can enforce here. And then, ultimately, when you're generating the documents in Ketryx, because this activity is complete, you know that the documentation is gonna be automatically generated from those requirements and risks, including their relationships to one another, whether you wanna have that in in a document or in an Excel sheet, are correct, are accurate, are complete, according to whatever process you set up by setting up a screen like this. And, again, I don't have a requirements to risk one here, but you could see I like I said, tons of, tons of processes are managed in Ketryx. I think the easiest way to show it is just, with this with this, traceability matrix drop down. That's primarily how we see people driving different processes forward by adding, all of these activities as a configuration here, which, again, quite easy to add as many columns as you want, as many filters as you want on particular columns and and how they cover each other. Okay. Well, thank you everyone for attending. If you have more questions, I think Joe has put a lot of information in the chat, including how to get in contact with us if you wanna dive deep on one of your specific use cases related to any of the features you saw today, not just the Google Docs integration. And then, of course, we we do a lot of these webinars around various topics and get some information about some upcoming webinars that should be quite exciting in the chat as well.