Cloud contact management systems for Life Sciences

How to create outlook signature

welcome thank you for joining our best practice series webinar I'm Becky melody your hostess for today's presentation Kevin Foley former FDA auditor and senior GMP auditor with us DM along with Matt Pelham principal enterprise solutions engineer for and cebu this our VP of us DMS IT and virtualization practice will be presenting the discussion today will cover introductions webinar logistics and our discussion topic how life science companies can use electronic records and e-signatures in the cloud we're proud to have kevin foley leading to audit initiatives for the usdm team he brings more than 10 years of experience direct from the FDA while at the FDA Kevin was a consumer safety engineer quality systems trainer and manager foreign drug cadre investigator and biologist analyst met poem has been with for over four years and serves as a principal enterprise solution engineer in his role he's worked with many fortune 500 and global 2000 clients to architect solutions leveraging the platform to help clients eliminate paper-based processes increased compliance decreased cycle times reduce cost and enhance customer satisfaction cebu this is the vice president of RIT virtualization and life sciences cloud practice at usdm he has more than 16 years of technology software development infrastructure virtualization validation and compliance experience focused on the life sciences industry usdm is focused exclusively on the life science domain and where the market leader in providing quality and regulatory IT compliance professional service solutions were headquartered in Santa Barbara California and we've delivered more than a thousand successful projects with over 300 life science clients we offer hands-on experience assisting clients under regulatory distress and where the market leader for support with our validation accelerator packs the various dedicated practices include global quality and auditing IT and virtualization of course life sciences cloud GRC our laboratory practice which includes systems and equipment ECM ERP PLM our enterprise quality management manufacturing automation and equipment clinical and drug safety business intelligence project management and most recently our track and trace serialization practice leading the new UDI compliance outreach usdm is very excited to partner with the global leader in digital transaction management because they empower organizations to become one hundred percent digital continues to see incredible growth and momentum and has been recognized as best-in-class innovative technology company currently reaches a global audience with over a hundred and ten thousand customers document signed in 188 countries in 43 languages they've been recognized as a best-in-class innovative technology company and most recently recognized as a CNBC top 50 disruptor together usdm and are committed to life science customers we have a few examples here of clients that we continue to delight as individual entities and then some that we're teaming with them mutually and we're just really excited about what we can offer together the content today will be covered in approximately 30 minutes and then we'll invite you to post questions for our team via the message board you'll find on the lower left of your screen or you can join the discussion on LinkedIn our usdm group and post any questions there we're happy to address questions of a confidential nature offline as well to shoot us a note usdm at USD mcom thank you so much for taking the time to join our presentation today and with that I'll turn the presentation over to Jennifer Moyer of thanks Becky I'd like to first highlight what we'll cover on the session today we'll speak about best practices for digital adoption and share a couple of use cases and then get into a live demo of followed by a discussion on and usdm lifesciences facilitate 21 CFR part 11 compliance and of course we'll leave time for questions at the end now I'd like to process our discussion on digital best practices by first honing in on the problem with manual paper-based processes and I'm hoping that seeing this picture makes you cringe a little bit seeing those snacks is paper in part because maybe that's all too familiar and probably quite frustrating despite the fact that we live in a world that demands mobile on-demand access to information companies are oftentimes still using paper printing scanning and faxing for everything from new drug applications can new hire paperwork and paper these days often connotes inefficiency and waste in short paper is a problem but what does that really mean for this industry what does that mean for life sciences organizations well really the crux of the problem is that all of the signatures that you need whether that for clinical site initiation trial recruitment lab reports and the list goes on all these approvals and documents and transactions when when you're using a manual paper-based system that's holding up the time that it takes you to bring the critical treatments that you're developing to market at satting days weeks months to an already decade-plus long process and it really doesn't need to be this way it shouldn't be this way in essence you know we're we're preventing critical treatments from getting to market faster by not adopting a fully digital solution this is really it's no longer the way to do business in this industry and this is a place where everyone is demanding change to keep pace is to fall behind and there needs to be a better way so in other words it's a mess out there and that's what this picture illustrates you invested in processes and technologies that next to your key stakeholders to critical business systems but oftentimes when it comes time to get a signature if you complete a transaction that process often breaks and we see that customers may be reverting to printing scanning faxing paper based systems that's slow that's expensive and that's error-prone think about what happens if you have a document that you sent from New Jersey to Switzerland via FedEx and someone missed a line or missed a signature that's that's happened before and that again just adds time to an already lengthy process now luckily there's a solution so I'd like to briefly go over the digital transaction management platform technology platform and what you're seeing here is it's not meant to show complexity but rather the robot robust capabilities that our solution offers enables our customers to prepare execute and manage their most critical business transactions this is all built on a foundation of industry-leading trust and security and in addition we have an open API both rest and soap and this enables our partners and our customers to really customize the solution to fit their needs I'd like to shift gears a little bit and talk about a couple of innovative customer examples the first one is cedars-sinai medical center Cedar sinai is the largest academic Medical Research Center in the western United States they have over 2,000 positions and nearly every specialty and they are using for their online registry and they have embedded into their online consent forms to sign up for cancer research and the results that they're seeing are really incredible since adopting and moving from a manual to to a digital process they've seen a boost of from about five five participants signing up a month to over 26 that's about a 5x increase that happens in less than a year and beyond that just sheer number increase what that really means is that they are able to have a more diverse pool of research subjects that is making their research results more valuable more statistically sound and because they have a more diverse pool that they're drawing upon their research population more closely mirrors the actual population of study so it's really doing great things for the research that they have underway and we're also delighted to report that they receive the award for best practices in human subjects protections from the health improvement Institute due to their use of the online consent forms in the registry then just touching on another example here this is a fortune 500 pharmaceutical company that's using for position contracts and to improve compliance with their corporate integrity agreements and the results they're seeing were taking up to six months originally for contract completion down to three days and that's that reduced turnaround time by improved turnaround time by 95% and added to that they're able to save nearly sixty dollars per document so you can imagine with the volume of contracts that they're sending the very real results both in time and hard dollar savings as a result of digital adoption with and I spoke about a couple examples really there is a world of possibilities and so many different ways that our customers are using today this is a little bit of a broader picture of some of the use cases in life sciences and you know we could expand this but it would really be an eye an eye chart because there are hundreds of use cases in this field but it's everything from your internal workflows whether that's a nondisclosure agreement or an HR onboarding form expense reporting to your most regulated processes like your regulatory filing patient consent forms lab procedures sign off and the list goes on get to commercialization use cases like order processing again I could speak about the long laundry list but instead of doing that I would like to pass things to Matt pelham who will show you in action and bring these use cases to life a little bit more so Matt over to you Thank You Jennifer let me go ahead and advance the slides and go back one before i begin into a demo i wanted to provide a little information about our platform what will be demonstrating in a moment is what you see here on the left which is the web-based console and this is because it's a cloud-based solution is a very easy way to quickly realize value and get through and implementation it uses our tools that I'll show in a moment and it can be deployed with very little or no I t involvement but that's just one way that our platform can be used our platform also can be integrated into other systems so if you have a research participant tracking system or investigator portal can provide the signing process embedded within those portals to leverage your existing tools and that can also help reduce training and provide tighter controls over how people access the system as well so it's quite a spectrum that's available to be used with in addition to the web console and the api's that allow you to integrate in the tool we also have some out-of-the-box integrations that are available for instance we support the safe biopharma digital certificates they can be used during the signing process to digitally sign documents we also have a very deep integration with the force.com platform and we are available out of the box in office 365 products such as SharePoint office excuse me word and outlook and we also have plugins for the behind the firewall installations of SharePoint as well 2010 and 2013 so there's quite a robust platform and today we'll just be covering a very narrow portion which is the web console so let me go ahead and move into a demo and I will share my desktop so now is the fun part where we're going to have a live demonstration so what you see on your on my desktop here is the web-based console that I'm logged into this is a tool that you can also access through single sign-on using the sam'l 20 standard to gain access to this tool once I'm in here as a sender of documents I see all the different transactions that are that i have sent i can see their status whether they've been viewed completed voided or declined I can also see how long they've been out for signature which gives me the ability to drill in on anything that may be taking longer than expected such as this one that's one to seven days I could drill in on that and bring up that transaction and I can see how long they've been out for signature for this demo I'm just going to do a very simple document i have an fda form 1572 which is used to bring investigators into a clinical trial and here is a list of my forms and i'll begin the process just by clicking that link to access this form that i set up in advance when i do that i come into this ending console and the first thing we'll see is that I have the document that's already here that was set up in advance I could continue to add documents so there's no limit to the number of documents that you would add to a transaction and in this case I have a single roll called the investigator which when I design this form did not know it until runtime who this would be for and I have a new investigator Aidan Parker who all adhered to this transaction the action I want Aidan to perform is just to be a signer although there are other actions I'll just stick with this one for now and there are other ways that we can help authenticate this person such as using digital certificates but for now I'll just use electronic signature and as I scroll down there's a couple other settings i'll just quickly go over i have the ability to set a custom email subjective message including being able to customize the language per recipient we mention the many languages that we have available and there's some different settings in here about reminders and explorations but i'll just skip over that here for the moment so now that i've addressed this I've just selected a form and added the person who will sign I can click send now but before I do that I'm going to click the next button here which will bring up that document so you can see how it was prepared for sending as this illustration is showing the administrator who came in before shows where they would be formed data field data checkboxes radio button signatures and simply move them on to the document as I'm you see me doing now so this was already set up in advance and can be locked down to add control for compliance so that I came out as a sender modify this document in any way other than addressing it but I did want to come in here for a moment to show how that easily it how easy it is to set up a form within Pakistan and in this case this was an FDA form that already had filled so converted these I did not need to drag these on excuse me they were already there so now I'll just hit the send button that transaction will be sent I will send an email notification to Aidan Parker that there's a document pending his signature and as the sender i see the summary information here for who will sign next right as live demos go my computer students going to blocked up but i'll go ahead and move forward what you would see here below is the book here it comes there we go you will see that i was sent by mat towel on the next to sign that Aidan Parker on the bottom of my screen so that was the sending process let me quickly move over to Aidan Parker's view of this transaction so i'll change web browsers here and we see that at eleven nineteen pacific time Aidan parker received this email message this email message does not contain any documents and Aidan does not need to have any software so there's no plugins or software required he just needs the ability to access this transaction and authenticate so that click the view documents button a new tab opens up and prompts me to login to I'll go ahead and sign in here and I come into the signing transaction now so just like from the sending view I see this information which I've prefilled just for the simplicity of this demonstration and I can click the next button and auto navigate through where my where actions are required or i can scroll through the document as I'm doing now a couple quick features to point out is feel validations one I have a zip code here but if i were to put in anything that didn't look like a zip code i would not be able to complete this form until I complied with this what this field requires so I'll go ahead and put a true zip code in and I'm okay on this field now next I get to some radio buttons where I need to either choose a CV or other statement of qualifications and when I click that any of these buttons will see an attachment icon appeared here it's additional driven on which document I choose so I'll choose CV and you'll now see that attachment icon and as this tells me I can click on this to upload a fax in a document instead of facts I'll choose to browse for my documents that I've scanned and here's my Stevie as I upload this you'll notice that I now have a second document in here and it has two pages is asking me if I have any other attachments i was just saying though and now that attachment icon goes to an upload icon and i'm able to move on i want to preview my document i can just click here on that thumbnail and i can see the document that i've added go back to my page here and i can continue to hit the next button and scroll through the various parts of this document and I've come down now to the area where I need to sign this document there's a simple sign here tag just like you might see with the sticky notes that when I click on that will apply my electronic signature you'll also notice here in the bottom there is a unique good that ties this adopted signature to this transaction as well as an envelope ID that is at the top of these forms that helps combine that signature here's the envelope ID and it correlates with this goo it here next I'll also need to choose a signature meaning you can populate any meetings you want all say that I attempt to the accuracy of this document and once I do that last required action I get the option to confirm signing if I had not completed everything you'll see that goes away and I'll continue to hit the next button and scroll through where required actions are I'll go ahead and choose confirmed sighting and when I do I'll be redirected cuz I've already authenticated us come back to my portal if however there were other transactions in here I needed to sign the can be configured so that when I access these documents for each signing I'll be prompted to enter a password so I'll go ahead and do that to demonstrate my ability to log in let's try that again that I would be prompted for a login for every signing I'll go ahead and finish this one later for that document that i did just finish i wanted to show the PDF quickly let me open the PDF I'll choose the download option here and I'll download the 1572 and let's display this in a in excuse me display this in Acrobat so that we can inspect this document a little bit more closely one of the things I'll show is the tamper evident seals the system places on this document which is visible by looking at the signature panel and we'll see here the the system rather than the recipient has digitally signed this document to provide a tamper-evident seal and we see the green from the green checkmark it says valid signature and that the document has not been modified since these signature was applied I see the envelope ID at the top of the page so we know that cannot be altered as well as the signature image here and the unique goo it lastly when we download these documents we also have as I scroll down there's my attachment as part of this document which is now also digitally signed and we'll see the certificate of completion here and on my screen will see there was one signing event by aidan Parker the security level was email he needed the email link to get access to the document and then account authentication was required he also signed at this IP address and we see the trusted timestamps of the system when he was invited to sign when he viewed it and when he actually completed signing so with that let me turn this back over to Kevin Foley hello yep hi here i got like well I'd like to speak for a few minutes on a few select areas of from a joint white paper that usdm and will be offering and coming out soon on how complies with part 11 part 11 point 50 a and B describes how the e-signature should have details about the signer when it was signed and the meaning of the signature if you're a call from the demo the signature component X are selected by the sender to drop into the locations within the document for the signer design these tags include all the aspects required by part 11 these include the date and time a signature which is a unique digital ID convo by the name of the signer and the main meaning of the signature this signature is managed at the time of the creation of the duck of the duck sign the document and is retained retained throughout the lifecycle the document the signature manifestation is displayed as shown in this slide tampering with this signature even if the PDF is out of the control of the envelope session will be apparent and evidence thus showing a an audit trail for anyone who wants to to make sure that there's security and compliance with part 11 part 11 point seventy is really about how signatures are linked within the envelope and more specifically within the document this signature is forever linked to the document and any tampering with this document say for example outside of will be evident tamper evidence is similar to a paper signature for example has mentioned furthermore there's a detailed audit trail of the entire signing life cycle which is present within the document and is there to see along with the record of being signed as shown by Maps demo part 11 point 100 deals with identity management which is controlled by you need to be a document user with your unique signature which is stored and encrypted 11.2 hundred is it really discusses a non biometric signatures docus I can use multiple levels of identification ponents from you ID password soar to level to level 10 occation as well as unique codes that can be texted to your cell phone for instance for instance additionally a fennec ation can happen using digital certificates an option that you're calm was shown by Matt so we we have a lot more details in in this upcoming white paper by our partnership Parker's and we welcome you to to look at this when it comes out soon and so we also we like to invite you to to put forth any kind of questions following this discussion or to forward them via email and with that like to pass a pest this one everybody good at dimona good afternoon this is to move at school viswanathan from us p.m. what's one thing to really have the system automate a particular business process that you may have but we in this business have to validate it sometimes you know the cost of these validations can be quite high and what usdm has been doing in the past over the past ten years is essentially developed what we call baps validation accelerator packs like we don't have enough to letter acronyms there's one more for you to remember these validation accelerator packs we've been developed a equal a variety of Best of Breed vendors that you can see on the right hand side of that slide we consider one of the best and great vendors when it comes to electronic signatures especially from a compliance perspective and these the vaps essentially provide our customers a starting point a very very good starting point for most typical implementations of or when you any other application pre-built templates for your specs your test protocols and so on and so forth throughout the lifecycle excuse me have a frog in my throat I don't know why throughout the life cycle of the validation effort usdm is VAP for is also part of our cloud assurance pocketing and I'm going to talk about that a little bit the cloud assurance essentially provides not just the map in addition it provides vendor assessments and vendor audits of documents conducted by an independent party in this case usdm and we maintain these maps for a period of time and we we are kind of we go hand in hand with along with their releases and as they release new versions of the software we're updating the back as well and our customers get to leverage that because you know it's easy to be one and done in this business especially when it comes to validation but as we all know things are constantly changing and in the cloud space things are constantly changing outside of your control sometimes and having a having the validation kind of tag along with it right in lock step is a phenomenal advantage usdm essentially together with enables life science customers to now use and validate regulated business process or fees with the technology with the technology the validation services combined with the cloud assuring cloud assurance offering apparently not just a frog in my throat the Frog is also chewing up my words the cloud assurance offering provides a a complete compliance solution that's based on gam gam five and other industry best practices usdm a doctor side can help our customers implement and validate in new areas that you've never used this before specifically to address the inefficiencies that you have with these paper-based processes with these documents flying back and forth etc it's easy to validate something one and done but I you know as you well know it's never the case in our industry change management and ensuring that the intended use of the solution we take it still maintained and manages you know is really really important this is also extremely difficult in the cloud space because typically you have the software as a service vendors we're like where changes are happening on their back end to support new features maybe a change to their underlying infrastructure or whatever and that doesn't really change say our intended use of the system but those changes are happening give me outside of our change control or change management prophecies so how do you how do you know how do you cross that hurdle and how do you ensure you still staying then you know stay in compliance we have various options on the overall cloud assurance package that you can pick that enables you to stay compliant and feel feel good about yourselves in sleep at night what of course is you know something that i was talking about earlier it's just a maintenance and upkeep of the validation accelerator packs of the paps and then hand in tandem with the system releases of document client can of course use and execute VAP as necessary furthermore you know obviously you'd want to audit and show that you know they're following the prophecies they're good quality management systems in place etc etc usdm can provide that for you we will do the vendor of audits on a predefined schedule and these audits can be left by our customers and used as part of their documentation package for the system certainly we could also completely hand over the validation testing responsibility to us p.m. usdm will maybe give me usdm will make in and validate the intended use of the system along with the periodic releases and making the validation package for as long as you pay again and customers pairs of subscription fee and will have full access to that documentation and that validation package and if additionally we're working on this with a few of our customers is with providing test automation options essentially periodic or the directions that that we can run on or a specified schedule or we can run along with the release schedules which are automated using HP QC or another time is a similar kind of an test automation sweet why the aggression testing again if you recall it was talking about you know you using for a particular use case or a particular intended use let's say has four release cycles a year or three release cycles a year but your intended use the way you want to use the system hasn't really changed you can run as part of your own tremendous short and sort of compliance perspective and change management perspective you can feel comfortable that you know you can run these regression scripts or system suitability test which I'd like to call these which is a very lab compliance term or lab lab systems validation term but when I like that term system suitability tab so you can run these steps which periodically to feel comfortable at your system is suitable for you for your intended use okay why do we get that a step further and actually automate those desk lips as well so those are options that we talked about ultimately I think this is a great partnership is constantly innovating and is a better breed software in the services vendor in the ecig space use usdm focus is on the life sciences and we our focus has always been the life sciences and this is updated button and we've been in this industry and we've been an industry leader for a long long time and we've been focused on this compliance space and that's what makes this a very productive partnership for for our life science customer and this is specifically important in this day and age where you know the life sciences industry is evolving you know the long-gone these monolithic companies where everything was happening within under one roof for under several groups under one company the industry is evolving the more distributed collaborative and specialized ecosystem where collaboration happens back and forth across multiple specialized organisations specialized in packaging products for example of specialized in manufacturing specialize in forming clinical trials or performing lab work etc and there's a lot of data and information that's getting and there's a lot of handshaking happening via corns and signatures etc and this information is you know it's hard to exchange electronically due to part 11 concerns validation concerns etc and more and more a lot of these systems that are used by these these specialized units are on the cloud adding to the complexity of the of the old compliance picture there's just so much paper moving back and forth that you know the document solution is not just a disruptive force but it increases efficiencies in getting this this information exchange happening in a very nice and compliant way but above and beyond that with the usdm partnership they're compliant to boot so with documents clouds cloud-based each signature solutions and us BMC cloud assurance cloud assurance packages you know you can deploy these solutions in a matter of days and weeks rather than months in a compliant manner and it's one thing to make that statement very poorly you know saying yeah well we're software in the service men do we can deploy these solutions in a matter of days it's a completely different thing to say that to a life science customer when the life science custom has to be we change controls and validation and documentation and things like that which is where this particular solution is quite disruptive and it's something that you guys should be interested in with that I'm unclothed and I would open the floor for questions and get a drink of water maybe Thank You Cebu appreciate that and thank you all to our presenters sharing some great information here as cebu mentioned we will now open the floor to questions and while you're typing those questions in i would like to let you know that the webinar has been recorded and will be available on our website which is of course usdm com looks like we've got quite a few questions coming in so let's jump right in the first one is John asking do you support saml authentication for sso this is matt Pelham with and John thank you for the good question and I will provide an answer yes we do support the channel 2 dot 0 standard for authentication of both senders and of recipients so we demonstrated today with just using credentials to login however the we could have mandated that all folks who access sender or shiner are authenticated by their own identity provider to gain access will also stamp in the audit log how those people were authenticated so there is information in the audit history that would reflect the sample authentication good question thank you thank you Matt Cain next question Susan is say what was shown looks like electronic signatures does support digital signatures as well another good question and this is matt from I'll I'll feel that one as well I just mentioned it briefly but yes we do have an integration built to safe biopharma which is probably of most interest to this group and that also includes a multi-factor authentication to the safe system so upon completion just like you saw here you after completing your document you would be prompted to enter your username and password for the safe credential then they would prompt you for a multi-factor authentication typically a one-time passcode sent to a pre registered device that would grant you access to that private key and allow the signing to take place the digital fining you will see in the completed PDF that there is a will that be the safe digital signature on that document so that auditors can see that but in addition you'll also have the audit history so you know a little bit more about what happened and when it happened and who else was involved in addition to safe we support open trust and zone digital certificates as well open trust is probably of interest for may be non-compliant or still compliant these cases especially in European localities thanks for the question thank you Matt here's a question from jiffy does aidan oh he's referring to the examples there does aidan need to register as a user the first time he logs in to and the follow-on question what does a user accept and is that legally acceptable sounds like other question so this is this is madigan thank you Jeff Pfeffer the question yes so when the person establishes their account in and a minimum and this may depend on your standard operating procedures but at a minimum they need access to that email address where they would establish a password it's also common to to establish that to use one of docuscience authentication mechanisms which may include knowledge-based authentication which is something that would be used for us residents because it's based on us public records it's also possible to use the one-time passcode sent to a known device or access code so there's several different layers Oh including phone authentication for a known device where it includes a voice print and ties that that person to a telephone number I think there was a second part oh and is that legally acceptable I don't want to give legal advice but in the United States under the federal lien act yes it is legal and what needs to happen is approve what transpired during that transaction and you would look at the evidentiary information in that audit history that i showed attended to the the document and if you're using digital signatures then it would be a fully qualified electronic signature where the issuer of that certificate was part of was proved by that locality that's true of both open trust and save file format digital certificates Thank You Man anything else anyone from the team might want to add thank you covered it Matt yeah well then gently let us know if that covered it for you if not you can send me another chat note there and we'll make sure we Circle up so our next question is from Jeff asking what is the overall stance of the FDA on gxp software over the cloud this is ago I can take that and Kevin you can keep me honest here you know as an ex-fbi auditor but there's no Stan specifically that we have ta takes I think ultimately a life sized company has to comply with the underlying regulations you know that govern that particular business process that you're trying to automate essentially the predicate rules governing the business process that in this case would be automating a part of that of course that includes computer systems validation and so on and part 11 the life science companies overall responsible but they can defer some of that responsibility to the vendor software as a service whether this document but ultimately they still have to ensure that the vendor is adequately covering the aspects of you know whatever is part of their quality management program or Quality Assurance SOC expectations saying oh we know you have a good quality management system what's your methodology for soccer software development and testing the customer probably has to do some level of validation on the intended use you know the intended use that against maps to the predicate rule and so on so there's no such thing as a one hundred percent compliance obviously you have to do you have to take some sort of the risk-based approach is questioning when it comes to validation and the the vendor assessments of the oddest as well as the the periodic tests that you that I was mentioning you know the periodic regression tests etc that I was mentioning as part of the cloud a shortage package will give you the the evidence or the support that you need to defend yourself if the FDA from then and on that question yeah thank you everyone oh sorry yeah this is kevin foley I totally concur with this boosts assessment there that really it comes down to what the predicate rule is underlying in regards to the GMP activities and so you have to base your rationale and your objective methodology or discussion to an auditor based on based on your on how you can how you comply with those predicates rules you're in ie or activities that are taking place the software that you're using for example that's why that's why Daka science-based it's base its very existence of these how it works on compliance very good thank you Kevin our next question is from Chris if you use cloud storage for data is the system then defined as an open system / 21 CFR part 11 this is so cool I can chime in here I've had several interesting discussions about this particular topic with a variety of my customers of course you know what is an open system or what does the closed system has always been a debate for a while now and the current stance and a lot of people have this stance where anything that's on the internet or the World Wide Web then it any data that's getting transferred across the cloud is considered open because with you know anyone can potentially intercept that information my argument has always been against that and believe me this argument falls flat a lot of times you know I can argue that you know the connection is secure you can ensure that the pipe is secure where they where the information is coming from and where it gets to is secure etc but it always comes down to this fact that if i'm not mistaken in somewhat own it is that the gates of the auditors themselves are getting trained on treating these the cloud base or anything over the web as a open system the subject to the the open system sections of our 11 Erika thank you can use a question from mark you mentioned integration capabilities how would that work this is matt i'll go ahead and tackle that from the side as mentioned has both a arrest and a soap api that can be used that provide all the functionality we've demonstrated today within your own applications so sending can be part of a closed system but that the management of the electronic signature process would be handled by but only accessible through that system and the way that it works is just a simple web-based API you know with request response to help provide guidance we have a very good developer center that includes common solution patterns as well as the ability to test drive any of our rest method simply by filling in a web form you can then see the requests and responses that are that are generated as well as look at sample code that can be used to implement any of those calls and all the various scripting languages as well and we have a professional services team that that can be used to help with that design and implementation but it's since we are cloud-based there's nothing to no hardware to configure so implementations are measured in weeks or very few months rather than and we know that the time frame is she most IT projects of eight to eight months to more than a year is a few weeks to just a few months depending on the complexity wonderful thank you can next question is how does work with safe biopharma I may have this is matt i may have answered some of that previously when we talked about support digital signatures and just to recap the process is very much like you see but upon completion you're prompted to authenticate to the safe system to access the private key that's two factor authentication and then once the signing completes you will see in the PDF that is available there's a safe bio format digital certificate a digital signature for that particular recipient rather than just the system digital signature that I demonstrated today to provide that tamper-evident seal and be happy to demonstrate that specific capability if you chat with me offline thank you mm-hmm okay next question is from Susan what is the purpose of the periodic regression test you alluded to this is sue bue and but perhaps I wasn't it wasn't extremely clear when I was going over this during the presentation itself essentially imagine the scenario you have validated a particular use case or a particular intended use of this application at point in time t 0 or january first 2015 and and then three months down the look down the road you have a version update on the back end of or or a bug fix or something else that happens since it's a multi-tenant environment it's going to be propagated throughout and someone within your regulatory affairs or QA may ask the question hey you know you validated this at time t 0 and now at time t1 you're telling me that the underlying the underlying system is changing even though you know that there is no effect or there's no claimed effect on the intended use we should still do some due diligence and then what you would typically do whether it was an on-premises system or an aura SAT system is you would run some sort of regression test some basic tests saying hey yahoo you know we change we change this database over here or we did something at the back end it didn't affect our the code gxp functionality that we validated before and here is the documented evidence why did not affect the RG XP functionality you know we ran some regression tests everything worked the way it worked at time T videos at time t1 or t2 things are still kosher and this is matt Pelham from dr. Simon tea and I'll add in just just one more piece and that although does release new software and it's a multi-tenant environment everyone can enjoy those new capabilities without having to go through the pain of you know installing paying for new licenses and that sort of thing but we do ship all that new functionality which is an extension of what exists today we do not want to break any of our clients obviously so we don't change the way that we operate but we provide new options that an administrator could request to enable and there's a standard operating procedure about how those changes would be implemented into your environment and if that were the case then that may impact how you use the system and how you validate but we anticipate that it should be a very light regression testing and that you have usdm to help verify that we've done nothing to affect affect compliance very good looks like there's a part 2 question again from Susan what's up and options are available can you repeat Becky yes what sort of automating options are available so we're working with a couple of our customers going to be doing it in using HPQ see the there's another and I can get some more details offline to you using something else for a sales force based solution as well which is not a to b QC but for the life of me I can't remember it now I hope that that answers your question this is matt i'll just quickly throw in that most likely when automation is involved it typically utilizes our api and it's up to you know the design at how that's actually implemented but since we have very atomic request responses that are used you can and the way we've architected the system that's it's very adaptable to whatever automation you would like to put in place but it's a great point that once you get rid of the paper and everything remains in digital you can do things like return form data that was collected on that 1572 into your investigator portal create new records update them be able to tell which protocol a particular research participant has consented to so all that can be updated programmatically so that it's accurate and always an up-to-date for everybody and then it can trigger actions such as to send new protocol to research participants for instance when a new protocol becomes available to help ensure compliance and convenience for everyone thank you matt with that I think we're coming up on the hour here we need to wrap it up I want to encourage each of you to visit the usdm website and find more information around upcoming webinar events there as well as recorded sessions of previously presented topics also invite you to join us join the discussion on usdm and there's a group page forum and you can stay up to date for upcoming events & presentations let us know that we're on the right track or if you have a suggestion we appreciate your feedback and suggestions for future presentation topics are welcome of course thank you kevin and cebu for presenting today and thanks to the team for joining us in presentation we appreciate each and every one of you taking the time to join us as we stay in the forefront of compliance we appreciate the opportunity to team with you in working towards excellence in compliance thanks again everybody have a wonderful day