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I hope thank you for attending the cloud content management for Life Sciences webinar I'm Manu vara i'm the managing director of global life sciences at box and also presenting with me today is my colleagues selling with era who's a lead sales engineer at box our mission that boxes to power how the world works together at box now we have 92 thousand existing customers across spanning multiple industries and life sciences one of our largest ones where we have over a thousand life sciences customers at box we define life sciences as either pharmaceutical biotech medical device or CRO in the life sciences industry the digital transformation has never been more urgent businesses just need to operate much faster than ever before that that's led to a few different industry trends for example the greater reliance on CR OS and CMOS which means a lot of external collaboration for business critical functions there's also pressures on the drug to market delivery times that demand faster innovation times while this is happening there's also workplace worklist technology requirements for employees that can either make or break productivity for them there's an increase the relevance of AI and machine learning on employee employee productivity and there's also an increased number of regulatory repositories that could potentially slow down output and overall efficiency of the department and while these industry trends are going on there's an increased risk of cyber threats and regulations most most organizations and life sciences are now operating on a global scale which means they're under regulations not just from one country but from multiple and also the increased risk of cyber attacks and ransomware attacks that life sciences is not immune to and content is at the center of a lot of these challenges with business critical functions like clinical trials manufacturing pharmacovigilance content is used to either maintain clinical study data to distribute critical procedures and documents for for machines and and scoped and pharmacovigilance where there is a huge process of in taking a lot of different documents that are coming in from across the globe and distributing adverse event reports that require the very quick responses that could be helpful for patients contest is also used across several GAA functions and commercial functions like sales marketing and sourcing and legal where you could keep documents like contracts and sales enablement documentation or promotional materials the existing technology is to house these house these types of different files and pieces of content that could be documents or or videos or audio files are essentially fragmented into two major categories so there's a enterprise content management systems which are essentially built on outdated platforms there are very complex and expensive to maintain they also lack external collaboration capabilities to support business with partners and external parties they're also too rigid and costly to update and maintain if you need to create integrations within these systems it takes a lot of time and an FTE count to create and maintain on the other side of the spectrum you have you have EFS s tools out there like onedrive Dropbox and Google Drive that are easy to use but do not really tied up mission-critical functions and and they don't have the content services capabilities to create business processes on top of to run critical business process functions they also lack the also like capabilities around automated workflows and metadata capabilities that you would expect to have from a world-class content management company so this results in a content fragmentation across disparate systems across life sciences many life science organizations have their content essentially spread across many of these different categories so when you have to move any file from from from one part of from one part of a process to another it takes setting up complex integrations and a lot of time and effort and if inefficiencies to actually move the files over and and to keep them secure a simple business process where you've created something internally on one system and then actually set up internal workflows over some other systems to the external collaboration using FTP FTPS or similar external systems and eventually publishing and archiving archiving the same piece of content that piece of content has is fragmented across different silos and integrations need to be kept and maintained just just to maintain any any kind of flow and that creates a lot of process in efficiencies and not to mention there it's also very unsecure the life sciences today need the cloud content management that's a single content platform to accelerate your business processes and improve employee productivity so with cloud content management from box you get a single source of truth for content that's integrated across all Best of Breed applications out there there's also seamless secure internal and external collaboration to operate on a global scale and with all your partners box also offers automated business workflows across the extended enterprise so if you have your content in one place you can you can apply automations and process efficiencies across the enterprise this advanced machine learning and AI technologies from all major vendors that we allow you to apply to to our to our repositories to gain some meaningful insights from from your ever-increasing content repositories box also meets the security and compliance needs for every for every industry and end up and the best to breed applications that we integrate with so what does it look like so at the bottom we have essentially our box platform where we apply things like encryption and policies and GXP capabilities and also allow you to pull insights from the content and then we expose a core API which which which allows our customers to leverage content services like metadata collaboration and workflow and how you consume this content this the three major ways you can consume content from box first we have the Box apps that are essentially of first party apps that we maintain and a lot of a live census customers use our web apps and our drive including our mobile apps to support their view of field reps for sales and marketing functions but with several other training functions as well these are apps that are maintained and by us and we control the user experience a second second way to consume content is through several integrations we offer over 1400 integrations with some of the best in breed applications out there that are offered that are working in life sciences today some of these also in addition to these also include Salesforce Adobe sign and and also an in-text a third way to consume content from box is to essentially create custom applications since we offer content services in the cloud our customers have even started building new applications for example like like customer portals and and also and also distribution applications where our customers are can actually control the user experience with their partners or their internal service providers with box now you can manage and secure all content across the extended enterprise which means you can start gaining visibility and control with one console and we're increasing those insights every era more more capabilities and reports and we also we also help you ensure the right access with the right permissions are granted to the right folks across the enterprise and this also lies it allows you to secure any sensitive data with the right access levels across the enterprise so nobody has access to anything that they don't need to have access to we also mean governance and compliance standards across across several different industries for Life Sciences more specifically we are now gxb ready which allows us to essentially apply GXP retention policies and allow a lot of defensible discovery of potential GXP data many of our customers also have data residency requirements which allow which require them to keep their content on the soil that they use it in and box offers a sones product where we allow a duplication of content across across several countries to meet data residency requirements when we look at our customers use cases and the type of maturity they have with their use cases this is kind of a use case progression maturity map even though we started our organization with individual productivity and team collaboration in mind we now we now offer our customers in life sciences to be able to use box for many collaborative business processes as well as operate as an intelligent Enterprise we're also making investment in products across content process and security to be able to enable an intelligent enterprise and a full digital work there's a workplace and digital business solution offering for all our life sciences customers of all sizes and segments but for Life Sciences are also now gxb ready so what does that mean what that means is essentially there's a one platform offering that follows our one platform philosophy with one platform for both regulated and unregulated content that doesn't mean it's a separate silo it just means it's the same platform by doing that it enables our customers to have secure transition of collaboration of collaboration content from either downstream or upstream of regulated business processes so you could be running a clinical trial that's non GXP but they really want to move that content over into a GXP regulated process while it's inbox it's easy to move that content in and out of regulatory regulatory repositories also when you're doing searches it enables our customers to search across both regulated and unregulated use cases and content just from within within the Box UI this also reduces a lot of cost in developing integrations between regulated and unregulated silos so if you break down the silos there's a there's no need to maintain separate integrations in separate silos and then separate FTE and investment costs to maintain those separate repositories a GX enable platform that also allows our customers to build custom applications and portals the traditional model of GX we implementations used to look like this where you would have an initial selection and a kickoff and then maybe about a six-month of an implementation project and then you would go live after your live you would go through a phase where essentially the system is feature lock for a few months until they realize there needs to be an upgrade or a security patch or a new feature that's required so you have to kick off a new project and then and then lock the system down after another goal live and then and then that cycle keeps getting repeated with the agile release model at box we created a GXP agile model as well to match one book after system selection process we have successfully deployed box within 30 days with core box capabilities to be to be ready for use for GXP purposes after that point if you require any more customizations or more complex use cases it will probably take what somewhere between one to three more months to go live and deploy your full application but once one box is deployed you're essentially in ongoing monitoring mode and there's no feature lock period and ongoing investments in projects and programs there's essentially an ongoing monitoring period that's coupled with the periodic incremental upgrades that are designed to fit right into your change control policies so some of the benefits of of box GXP is you're able to consolidate to a single platform and accelerate and simplify the validation process and we offer several accelerators to support our customers for that purpose over a course of five years we estimate our customers can save about 85% in costs and 50% savings in time in deploying box to XP it's a box for enterprise yeah it has been deployed at several of our customers right now many of our lifetimes of customers are using this today it offers a digital workplace solution that enables field sales and marketing support mmm any virtual data rooms individual repositories promotional material distributions and also a repository for training functions like finance legal and HR once we start adding our extra capabilities for example our governance products our customer is able to start using more collaborative business processes like digital asset management and content portals by adding box GXP validation or system is still the same it does not change the features and capabilities but it does allow our customers to now unlock the ability to the u.s. box for regulated business processes some of the most popular one - the first - which is around CRO and CMO collaboration and also managing SAS data sets we also offer a progression path for our customers into more specialized business processes through partner integrations so the constant content still stays on box on our box platform but through partner integrations were able to meet our customers needs and life sciences for specialized business processes such as ET MF or regulatory submission documents labeling and packaging notes equality sop management and we have a quick example of that today that's without without a partner integration but right natively into box at this point I'll hand it off to my colleague Philippe to do a quick demo of bak great thanks manu so i'm going to walk you through a short demonstration of a standard operating procedure or SOP approval process that incorporates both documents and video this was produced out of a proof-of-concept we conducted with a quality management team at one of our customers the leading life sciences company and it was based on their business requirements I'm gonna start by uploading a sample SOP video to kick off our scenario and while this workflow starts running in the back let me talk about the customers business challenge so the issue they faced had to do with the way that they've managed iterating new versions of their SOP content many of their SOPs included not just documents that explain different procedures but many of these documents had corresponding videos that visually demonstrated the procedures as well our customer had an ECM system in place for their documents but it wasn't capable of handling video files and so as a result the customer had a separate system just for their videos as well as a separate workflow process for managing those video approvals and this resulted in disjointed and cumbersome approval flows because the approvers had a hard time associating the right documents to the right videos and had to jump back and forth between two different systems so we built this POC demo using capabilities from box as a Content layer for both the documents and video as well as ninh Tex as the orchestration layer and we put a scenario around it so in this scenario SOP video offer Peter will upload a new video into box which we just saw and this will trigger an in-text workflow for the video approval that will first check to ensure that another quality team member has already uploaded a corresponding SOP document for review if that's the case the workflow will route the video to an approver named Fiona to review the video will also be put into draft or review status using box metadata fiona is going to receive an email asking for her to review and approve the workflow the email though is also going to include links to the SOP document in the video and once Fiona approves the workflow the SOP document and the video are put into for training status Fiona will also associate an effective date as well as other attributes to the video using box metadata now Jacques is the manager and he gets sent a secondary approval notification that prompts him to review the video as well as a document and then approve once Jacque approves the SOP the video and the document are automatically moved into a published or effective status once the effective date that Fiona had previously specified has arrived so we started from Peters perspective where he just uploaded the SOP video into a marked video ingestion folder now access to these folders for upload review and published content is dictated by boxes flexible security model which helps you ensure that participants can only see and access what's pertinent to their role in this case because Peter is only uploading content he has been restricted to only have uploader access on this particular folder this means that Peter cannot view nor modify other videos that may have been uploaded into this folder by other team members now once the video has been uploaded the reviewer Fiona will receive a notification prompting her to review the video and approve it alongside adding some metadata this will all be done through the use of Ninh Texas notification and web forms capability here's an email that Fiona has received when she clicks on the email she sees links to the video as well as the SOP document for her to be able to look at now clicking on this video link takes her in to the video which she gets to view using boxes preview capability if she's on a mobile device like her phone she could also preview the video and document from there as well back in the email she also has a link that prompts her to click on and it will take her to what's called a video approval form and this video approval form is delivered leveraging in Texas webform capability within text the customer has the option option of configuring the webform for to capture whatever information is needed and then populate that information is metadata alongside the video inbox in this web form field is prompted to approve or reject the video she could also enter in a date for which she wants the video to be automatically made effective after going through a training period in this case she's going to enter in an effective date that was in the past so that the video would become effective right away after its final approval she could also enter in the facility that she wants the SOP to apply to and then she clicks on approve and submits the webform so once Fiona has approved the video the nintedo into a four training folder now for the customer they wanted to be able to have their SLP documents and video available to view after this first approval so that their staff could start training on them before they become officially effective when we look at the video and box we could see that some of the metadata has automatically been added by nintedo Stu for training and through boxes flexible permissions model you can also give certain stakeholders the ability to manually update the metadata directly in the box web user interface so meanwhile Jacques the manager has now received an email prompting him to approve the SOP document the email provides links to the document for him to review the email also it's a link to the corresponding video in this case once Jacques has reviewed the document in the video he could simply reply to the email with the message approve so now that the video and document have been approved they will be moved into the published or effective folder and have their statuses changed to effective on the date previously specified in the approval form by Fiona if there were previous effective versions of the SOP those previous versions can be moved into an archive location to be retained as long as needed for regulatory requirements so let's take a look at and see what we have now so looking at the video in preview we could see the accompanying metadata shows that the video is now in effective status we could also look at the corresponding SOP document and we could see that the document has been moved into the published folder to be a made effective as well we could also use Nintendo in addition to the preview and navigation features our customer also wanted their workers who were consuming the SOPs to provide feedback on them as well so leveraging boxes commenting feature you could he could I have a perfect solution for this where users could post messages in the Activity Stream so overall we hope that this demo has given you a better understanding of how box in tandem with orchestration tools like nin tex met the needs of the SLP approval process use case for this customer with that I'll hand it back over to menu Thank You flame for that demo at this point we'll take a few questions before closing it out so I have a few questions out here the first one being does box meet requirements for 21 CFR part 11 so the answer is yes box does meet the requirements for part 11 but only for the electronic records part in order to enable for part 11 compliance if you need electronic signatures as well we recommend integrations to either or adobe sign that have active and ready integrations with our product there's another question we get this box works the Box workflows work with other systems like so the answer answer is e and answer is yes and no in a way so our internal workflows only work within box but we do allow passing the right metadata to two darksign or other systems through other products like mint X another question I got here is our other customers using box for GXP purposes the answer is yes we release box for GXP last year and we have several customers using box for exp purposes that span from four people companies that are still early stage and small businesses all the way to large enterprises that are over ten thousand users the use cases do vary based on based on the different functional areas but they span primarily between quality and clinical another question I have here is is an index the only tool used for customized workflows and the answer is known in text as a partner and we have several other partners like like a peon and we all saw that can also be used to essentially create customized work flows between box and other best-of-breed SAS applications in text is just the one that we use today for demo purposes I think that's it for today I'd encourage you to reach out to us if you have any further questions and thank you for your attendance