Cosign Signed Electronically Request with airSlate SignNow

Cosign countersign template

hello and welcome to today's webinar cosine digital signatures from life science organizations my name is Raj Fleur I'm the life science practice manager at airex I'm here to discuss cosine digital signatures what they are why they're being used and what the most common applications are our cosine and life science applications for those of you that have questions to ask today feel free at any time to enter a question in the gotomeeting panel on the right hand side under the questions tab before i get started about cosine i wanted to give a background on air x air x is the company that i work for and our flagship product is cosine cosine is the most widely deployed digital signature product on the market today we deliver cosines and target applications in highly regulated markets as well as government year-over-year the life science market accounts for about thirty to forty percent of our total revenue other key markets that we deliver our cosine product in include government here in the US Canada Europe and around the world as well as in engineering applications healthcare research driven operations and the energy market here's a snapshot of some research performed in 2013 by Forrester Research and among other things they list the major suppliers of electronic and digital signatures in the marketplace today these leaders provide electronic and or digital signature solutions some of the vendors provide cloud-based subscription models while other deliver an on-premise solution and some vendors such as a RX with a cosine product deliver just the digital signature engine while others provide a more complete solution with our own workflows document manager and user management functionality we all serve different parts of the market as I mentioned before our target with their axes in the regulated industries as you would expect as a major supplier in the FDA regulated markets most of the major biopharma medical device clinical research academic research government research as well as suppliers in this industry are using cosine today in fact it's been estimated that about ninety percent of all digital signature usage in the FDA regulated markets is using cosine today so why digital signatures a case you're not aware there's a subset within the electronic signature world it's defined by a standard in the term we use to describe these standard electronic signatures is digital signatures here in the US the standard is published and maintained at the federal government level by the National Institutes for Standards and Technology yes but the same exact standards defining what a digital signature is are also adopted and endorsed and incorporated in legislation throughout Europe and rest the world by independent standards bodies and also supported by the independent software vendors Microsoft Adobe Oracle's and others of the world and digital signatures provide not only information about the signer and the signing event but also provide data integrity checks so you can tell if any content has been signed within a document has been altered in any way since the signature of signatures were applied we're not going to go through a demonstration today but I wanted to show you a typical tiny process and workflow as someone is signing with the cosine product before someone can sign they're generating account and many cosine particularly on-premise installation for enterprise usage cosine is integrated with the corporate user directory structure most commonly Microsoft Active Directory but cosine also supports other ldap structures virtual directories or many cloud applications cosine is integrated with an Oracle for a sequel database where users are enrolled directly in the cosine user database regardless cosine can deliver high to medium assurance digital identities depending on how these integrations are performed when someone the has an account is ready to sign they're sitting in front of a pc a mac or a mobile computing device and then click on a document a common file format to sign that file and any fda-regulated application where 21 CFR part 11 is applicable there's two things that need to take place before the signing can commence one is the user is prompted to Rio Pennock eight and this is typically through Active Directory user name and password re-entered every time someone wants to sign a document the second thing the FDA requires is the entry of a reason college a reason for why I'm signing these reasons can be managed through cosign the publish standard list across all users or specific list for specific users once these two items are entered the username and password in the reason code and in a fraction of a second behind the scene cosine accomplishes a few few items first thing that happens is that the document contents are expressed as a mathematical equivalency known as a hash value this hash value is encrypted it is the only content that is routed to the cosine server even if someone were to intercept this communication and decrypt the hash value all they see is an alpha numeric expression in no time is the specific content private or confidential information to someone stealing and seeing that information once the hash value the username and password and reason code are received at the cosine server then cosine goes ahead and signs that content with the unique signature key of that individual this is for data integrity purposes the next thing cosine does is it grabs the digital identity the digital certificate of the signer and includes that with a signature record along with a graphical signature if the signers chosen to include his handwritten signature corporate logo or some other some other graphical branding and all this information is down back to the signed document along with the time/date stamp when each signature was applied ok I'm hearing that someone is not getting the audio and I want to check to make sure ok fine now okay moving ahead to the next slide once I've created this digitally signed electronic record the reason to use digital signatures is I can securely exchange or submit this this signed document which any business partner external suppliers vendors regulators courts of law as well as other colleagues and they can fully verify who signed the document when they sign the document why they sign the document and they can verify what's been signed and whether that contents been altered and this is all performed independent of air acts an independent of our cosine product so even if cosine is decommissioned at some time in the future all the digitally signed electronic records that the products created over the initial use period is still fully verifiable even with cosine out of the picture this is the value of digital signatures so what if this verification process looked like we call it the three eyes and the three eyes include information about the identity of the cider the express intent of the signers of signing a document and the integrity of the data contained within the document so when I open up a sign file for instance a PDF I'm going to see visible evidence of each signature event in this case the name of the signer the job title the reason code entered the time/date stamp when the future was applied I can see visible information about the graphical signature this was included and then there's other information included within Adobe Reader such as an indication that all signatures contained within the file or valid and can be trusted there's even a ribbon I can open up it gives more additional metadata that's each signature contained within the file itself now these signatures within a PDF our active components so I can drill down and see additional met data information about the signer a signing time the reason code whether the documents been altered I can even drill down as far as seeing the digital certificate or ID card of each signer who issued it was the certificate valid I'm assigning one organization the signer is a part of and again this information contained within this PDF file is literally littered with information about the identity of the signer the expressed intent of the signer and the data integrity so as you can see digital signatures are not just an electronic replacement for pen and paper those additional securities they're added that strengthen the trustworthiness of the electronic records camping in the transition now into y cosine and talking about cosine in two main application areas one is for the enterprise for employees views and the next is for cloud applications where I may want to have non employees outside parties Sun and documents okay for the enterprise cosine is deployed today in several hundred different life science enterprises in back office operations for corporate governance and of course these are highly structured repeatable low-cost operations where many signatures are required throughout any organization I we deem that's a closed system for all the signers are part of the same organization is all the relying parties that people need to verify the signed documents and the departments that you typically see this in would be finance HR procurement accounts payable accounts receivable in quality management among other operations now the ARX philosophy is that you already know how to govern your business and this have established policy and procedure so our cosine product needs to fit into those existing policy and procedure we're not going to dictate to you that you need change the way you're doing things just use our Google signature product the next area I'm going to talk about after a get more detail about cosine for the enterprise is cosine for cloud applications so this improve includes both private clouds then an enterprise may want to prop up for business partners and collaborators to work with or it could be a private SAS software as a service vendor who wants to embed cosine as a signature engine for their cloud service so again we're talking about collaboration and customer acquisition the collaboration piece would be what I would call middle office where you may have persistent signers that are partners for subcontractors working on manufacturing clinical operations and other activities that you need to sign documents or it could be front office one time signers such as customers working in an online store we need to sign some information in order to purchase the product off your website whether it's middle office a front office in both cases this is an open system application as defined by the FDA where signers spread or spread among many organizations and the parties need to rely on these signed documents are also spread among many organizations and the FDA under 21 CFR part 11 specifically in paragraph 11 30 controls for open systems talks about the use of digital signatures for any signature operations performed in open systems okay so let's go let's talk a little bit about cosine what's delivered with the product okay so you can sitter cosine as a centralized signature engine that's deployed in a cloud or deployed in the enterprise cosine as I discussed before is one hundred percent standard digital signature technology do we adhere to the standards put forward by NIST Etsy and others there's several different flavors of cosine they're defined by different security profiles our bread-and-butter product we deliver for the life sciences industry it's what's known as our enterprise or en t cosine appliance but we also offer a fifth appliance which has a special security profile it's applicable particularly for operations within government or the European market place and then finally you can consume cosine as an on-premise solution within your own enterprise or a RX host the cloud service that you could also use regardless of whether it's an on-premise solution or cosine cloud there's a few things that we generate when we set up an account for an individual user inside of the cosine server the first is cosine has a built-in certificate authority a CA where we didn't generate these ID cards known as digital certificates for each of the signers these digital certificates can be standalone or they could be anchored in an adobe trust or microsoft trust network or they can also chain up to european qualified certificate authorities as you might see in certain jurisdictions along with the digital certificate cosine generates the unique signature key that's going to be used to sign content whenever a signature operation is initiated by any signer and then the third thing is each account can have one or multiple graphical images associated with each user such as a handwritten signature a John Hancock initials a corporate logo or some other branding that you'd like to see displayed time you signing a document so that's the cosine centralized architecture now when we put cosine inside of an enterprise for some considerations that you may be curious about one is how our users managed and that can touch them this before briefly the most common setup for cosine is the integration with Microsoft Active Directory the cosines installed a security group inside of Active Directory is created and employees that you want to give signing capabilities to are enrolled into this new security group cosine also supports Active Directory Federation services for more complex Active Directory scenarios costco sign also supports other ldap structures as well as virtual directories and ultimately what you're getting by integrating cosine with your user directory structure it's very well-formed high assurance digital identities and this is because in order for an employee to end up in your Active Directory they had to go through the new hire onboarding procedures in the IP security requests you'd be set up with an account inside of active directory and ultimately inside of cosine so how our users authenticated at the time of signing the most common setup is for the signers every time they sign to enter their Active Directory user name and password now cosine also supports other two factor authentication techniques including smart cards pci cards one-time passwords biometrics or any radius oath or sam'l supported standard authentication techniques cosine also supports single sign-on and as I mentioned a fourth graph reification at every time a documents to be signed and the server also manages these reason codes I discussed before essentially so that I can publish global list of reasons or give a specific set of users individual reasons choose from for I could allow my signers to on the flag at any ad hoc reason they see fit when they're signing a document what file formats can be signed there's a wide variety of file formats that support digital signatures and cosine supports this includes the microsoft office suite word excel as well as infopath and powerpoint and outlook emails adobe acrobat and adobe reader of supported digital signatures for over a decade but now any I so compliant PDF viewer or creator supports digital signatures is whether as well as other file formats such as tiff files or engineering drawings cosine also delivers a utility that allows you to take any printable file format would be a text file or web page publish this to PDF and sign it as a PDF with this on the sign feature that we deliver cosine is typically used for individual user signing so I want to sign with my unique identity however cosine also supports what we call system signing meeting I want to signing on behalf of a group which I'm a part of maybe I'm the marketing Europe maybe I'm in a lab group you know an essential lab and ten people can all authentic eight against the single system signing key and apply a signature on behalf of the group you finally cosine also supports back signing so perhaps you're working on in a archiving or an e invoicing or signing a bunch of validation or software development documents all in one step cosine fully supports that and the signatures the cosine applies can be either tamper evident are tamper-proof the tamper proof once I sign no one can change the contents of this document or perhaps I want to make a tamper-evident changes can take place but if their changes made I want to indicate it as such it's finally cosine also supports sectional signing so I can find just portions of a document maybe just a section of a word document or a range of cells inside of Microsoft Excel and as long as no one changes the content that's been signed within that section then other colleagues can work in other sections of those words and Excel files a quick check here see another question ok so what business systems can be used so in addition to different file formats the cosine supports cosine is typically integrated with enterprise applications a document management systems quality management systems workflow systems enterprise resource planning customer relationship management systems in fact about half of the installations we do in the life sciences industry cosine is integrated with Microsoft SharePoint and this includes sharepoint 2007 and 13 and now sharepoint online through office 365 now if we don't have a cosine connector for an application that you want to integrate with we do have a developer's portal which has all kinds of api's code snippets documentation it has a forum to be able to ask questions and interact with our technical support people in finally cosine supports multiple computing platforms so it's not just pcs anymore although we do have advanced client software specifically designed for PCs you can also assign with these cosine connectors through a browser on a PC and Mac or any mobile computing device we also have a general-purpose web app where you can pull a file into the web signing ceremony and apply a signature within within the browser as well as a specific clients for mobile apps for iOS and Android devices so is cosine for the enterprise and next I want to transition into cosine for cloud operations so whether you're a SAS offender or you're an enterprise that wants to prop up your own private cloud service they're special considerations for using cosine as an engine for these clouds first again is how users are managed although we have integrated with active directory for ldap structures in the past most of our customers do not manage users across many organizations in these common user directory structures the most common setup is cosine either integrated with a virtual directory which can then bolt on to multiple user directories or users are managed in an oracle or sequel database or directly enrolled into the cosine user database regardless it's your ID proofing policy and procedure the cosine is leveraging for how you vet the identities of these individuals a cosine will then generate an account for them to sign with our users authenticated this is different from the enterprise most of the customers that we have that have external parties out in cyberspace that wanna signing documents they're leveraging simple user name and password and essentially eliminated the requirement for any two-factor authentication to be able to expect someone out there that signs in frequently or maybe one time to have to have a smart card or biometric device or something similar it's not a reasonable approach to a digital signature automation so again simplicity drives user adoption and also reduces the amount of support but people can't figure out how they're supposed to sign now as I mentioned before four signers collaborators you're going to want them to remember a username and password but perhaps you also have an online store or some application where you need just a single one time use identity for someone to apply well in these cases cosine can leverage use of a vetted email and perhaps a pin that's texted to the mobile phone number of these individuals to strengthen the identity proofing and authentication at the time of signing now we also have customers that do point-of-sale pull your service type applications so in these cases it's where I have an agent working out in the field in front of a customer and that customer needs to sign one time so instead of creating a digital identity for that individual what I allow is for that individual to scribble they're handwritten signature on their iPad or on some type of tablet and then as the witness as an agent for the organization I digitally sign on top of that graphical signature in enter in a reason code which acts as a witnessing statement essentially notarizing the graphical signature of the 1-ton site ok file formats this is there's some file formats that just don't lend themselves very well to web-based applications but others do we found that PDF or web forms is the preferred file format some customers also leverage word and excel as a format to be used for website signing in a browser based environment what business systems can be integrated again any web-based enterprise application collaboration application is appropriate here even customize web apps you may develop for your cloud service and since we don't have a connector for these customized web apps again you're going to be leveraging our developers portal to do that integration and what computing platforms again if I'm asking some outside party to sign a document I have no control or no knowledge of whether that individual likes to sign or access documents on a pc a mac or some mobile computing device so i want to make sure that whatever i'm delivering works on these devices this includes all the cosine connectors that have web-based interface is the cosine web app a general-purpose web signing solution as well as an application called cosine click which is a feature set that can be added to any type of web application where I can invite someone to sign one time through an email request and then text them a pin to enter flood Medicaid as they sign by clicking the link in the email okay so again we want to make sure that we're doing browser-based signing no client-side software we want to make sure that an individual can sign from any device not just assume they're using a PC and that's that's how we leverage success in cloud-based applications okay so now I transition to the business side of things I want to talk a little bit about the return on investment then the key use cases for cosine in life science applications okay so here's some here's some results from a survey performed by aim the association of information management going back a few years ago and they pulled their members and the respondents provided some interesting feedback on the use of electronic and digital signatures over forty percent of the respondents said that they need to have at least one signature on over half of the documents they create over half the documents need at least one signature almost two-thirds and respondents said for their business processes that require electronic or digital or ink signatures if they stick with paper they've added at least a day with the time the process and complete these required documents and finally almost half said the only reason they print out documents today is for capturing signatures almost half said that that half of the documents they print out our only printed out from the purposes of capturing signatures pretty incredible information now we also had aim poll to find out after digital signature deployments what were the results well over two-thirds of the respondents said that they save time human time associated with scanning copying routing documents throughout the office across multiple offices almost two-thirds also said they reduce these bottlenecks and lag times in their business processes completing documentation once they went fully electronic and over half said that they save significant hard costs associated with paper he vaccine corryong etc I would have thought that number higher but significant savings in hard costs through will go in fully electronic and four or five of them said that they saw a return on investment at payback from investing in electronic or digital signatures in under 12 months and a quarter of em said their payback was actually within 90 days the very quick payback period some other metadata on business drivers so again papers expensive I think we all know this surveys done about a decade ago one by Oasis one by pitney bowes both stating that the cost of an average paper document with an ink signature over the course of its lifetime is anywhere from eight to ten to twenty dollars and in the case of documents that have been lost or damaged that replacement cost could be as high as 120 150 hours McGinnis is from ten years ago a pfizer actually published a study back in 2007-2008 were they estimated for every wet pink signature they place on a piece of paper they can expect that to have a costs over the life cycle of that document of up to thirty dollars and any time we have remote employees we're talking about even more expensive business processes and expense to to handle paper with ink signatures good example would be trip reports very commonly clinical trial applications where a clinical research organization like PPD in order to expedite the completion and signatures on these documents is spending a lot of money with quarters and FedEx and UPS so you have a field-based monitor out there at a site generates an initial report goes back and forth several times it's a home office finalizing the report once the reports finalized this remote resource is signing a document fed exing it to the home office for a second signature and finally it's fedex off to the customer the sponsor the pharmaceutical company incredibly wasteful in the paper world very efficient in the electronic world and of course times money and we know this in all operations but in clinical in particular since you have a very limited exclusive patent life for drugs as they get through the clinical trials and our approved and marketed you may have three years or five years or seven years if you're lucky of exclusivity on that particular patent and once you go off patent of course the margins are deteriorating quite significantly so you want to do everything you can to make your operations in clinical in clinical manufacturing in commercial manufacturing is efficient as possible to maximize your market share revenue on that particular product you finally a transition into the top ten use cases believes a touch long before so number one use for cosine today it's for quality management systems for qms this can be with or without a document management system so quality management system of course is the core compliance platform within any life science organization it includes all of the SOPs work instructions training records and project and pass specific documentation it's used to support an fda audit a vendor audit and over a hundred different life science organizations today use cosine integrated with a quality management system design documentation it if we're integrated with the qms for a document management system this is through these cosine connectors that I've talked about before now the bottom line is that over the past decade over 10,000 different FDA audits I've been conducted successfully using digitally signed electronic records created by our cosine products now if you may ask yourself why use digital signatures in a closed system like a quality management system why not just electronic signatures after all it's just employees signing other employees verifying signed documents and the driver here is around flexibility and agility if I'm using digital signatures to sign my electronic records independent of the repository if i choose to migrate through new quality management system in a few years or a new document management system the migration effort of moving these records from one system to a new system in the future it's going to be greatly reduced since i'm signing my documents with standard digital signatures and not tying proprietary electronic signatures to a current repository so that's our top application another very popular application for cosine is with clinical research associates working for see arrows are for anyhow clinical operations signing trip reports and just mention this with with PPD today about 50 different see arrows and academic research organizations use cosine and there's well over 10,000 different see Ras and project managers using cosine to sign that short reports say sometimes cosine is used just to sign nice trip reports directly within the PDF or word file format but other times we're also integrated with some type of work product like Oracle clinical or reform of solutions or y prime where they're helping to generate the finalized report and applying the signatures within the user interface provided by these platforms within the medical device industry we do work on field service reporting so I may have a field service rep out there where I have one of my products installed maybe in a hospital setting doing periodic or annual maintenance and calibration work and I needed to sign that report maybe I also need the client to sign off on the completion of the scope of work so it could be a point of sale type application someone like like meh drag a subsidiary of fair pharmaceuticals estimated with just employment for 100 field service reps their first deployment of cosine and say they saved an annual 150 thousand dollars you got to pay back period of under three months okay they can just like trip reports cosine can be deployed side by side we're fully integrated with a customer relationship management tool Salesforce or dynamics or s AP lab reports so today we have over a hundred different central labs using cosine and millions of lab report sign on a daily base or a excuse me on a yearly basis an example here would be Maxum analytics it's the largest independent privately owned Latin network in Canada they operate 15 laughs and they have their own proprietary laboratory information management system which they integrated with cosine so the project managers can generate a report in the lymph system siding with cosine then they can electronically post it or distribute it back out to their customers field sales documentation so I've seen sales reps out there perhaps they need someone to countersign an agreement or contract these contract lifecycle management applications sign has connectors till one of the platforms would be someone like CLM matrix which has a SharePoint base CLM system as cosine fully integrated can be accessed again through a browser product portals in particular patient assistance and reimbursement portals so a good example here would be at v-0 bad at labs pharmaceuticals business there they're leading product humera they've integrated cosine with a web portal so that any one of the 10,000 locations where doctors are prescribing humera today a patient can access various forms that they need to fill out and submit its applied for financial assistance and the way add via set this up is the patient simply needs to graphically sign on a tablet device and the witness is a nurse of the prescribing doctor who then digitally signs and offers up a wincing statement notarizing request on behalf of the patient we also have cloud vendors SAS vendors that do this exact same thing someone like RX hope which any pharmaceutical company can register one of the product with and solicit patient reimbursement patient assistant requests investigator portals is another big application area for cosine today and with the emergence of trend cell array can be vitally important across the industry as a whole today cosine we have about 10,000 different site personnel investigators principal investigators some investigators clinical research coordinators I arbys etc that use cosine either through an on-premise cloud application propped up of one of our pharmaceutical customers or we also have partners that offer up the cloud service like next Doc's monstrum d Pharma solutions for AXA trials and again we're targeting the site initiation documents the regulatory packet documents that each site needs to have signed off on before they can be green lighted and start recruiting scheduling patient visits electronic lab notebooks this is back in early rd any scientists biologists chemists patent attorney working with in life science organization needs to sign off on discoveries and experiment results ultimately using this documentation for patent applications patent submittals patent defense and the digital signature seals the contents like approved what was discovered along with the time/date stamp i'm able to substantiate when this discovery was made so as you may know in the US two middles to the US patent and trade office it's not who arrives at the office first but who can verify that their discovery happened first so the time/date stamp that cosine provides is vitally important in these applications in manufacturing operations electronic batch records organizations like a legate and they're both docs manufacture and use cosine the sign off on their master recipes for control recipes and that each manufacturing staff in the manufacture of a particular product in the case of allergen is interesting they're working in a clean room environment so people are are gloved inbound and it's very difficult for someone wearing gloves to type in their username and password food allergen is chosen to do is to have wristbands that i can swipe on barcode readers anytime they want to sign off on a manufacturing step and the manufacturing steps are actually managed in Excel so each row or a group of rows within an Excel spreadsheet signifies a particular step in the manufacturing process that each user a signing off on as they complete it only the last application areas around informed consents not just for clinical trials but also in departments of health and hospital settings and the largest deployment we have in this area today would actually be at the state of South Carolina Department of Mental Health which is 21 state-run hospitals and clinics with 3,000 medical staff but whenever a patient or a patient along with a guardian arrives at one of the locations there's a few registration forms informed consents and ultimately some recommended treatment plans that the patient of the guardian needs to sign off on and this is pure point of sale so at each of these kiosk around the facilities to have the patient graphically sign off on the consent forms and then the witness being a emitting nurse registration nurse or a doctor the witness this graphical signature then digitally signs and offers up a win these witnessing statement on top of the graphical signature so those are the top 10 applications for cosine I want to move along now to the Q&A session and remind the participants that on the gotomeeting tab on the right hand side there is a questions box and I'll give a few seconds for people to start asking questions you okay the first question is around validation computer system validation for cosine on our websites or if you email at FDA at a RX com we can send you a wealth of information about the typical activities around part 11 compliance validating cosine is computer system a qualification of ARS to the vendor but in general cosine is viewed as a black box device and the validation efforts as such are greatly minimized we deliver our black box or you consume it in our cloud service you cannot touch the operating system or the application running within that black box appliance it's much like a router sitting on the network that doesn't need expensive validation work now there's some light configuration settings so now we interact with that box and we do document the setup and installation of cosine as we integrate with Active Directory or user directory structure so Eric does provide some supporting like you documents for the most part our customers are doing their own development of test scripts and execution of test scripts and validating cosine on their own but we do have a partner network with also has expertise in this area ok the next question is around sharepoint one versions of sharepoint we actually do some integrations of cosine to SharePoint back in 2003 but today we support 2007-2010 2013 sharepoint online through office 365 we also support that many of the complementary workflows such as mintex & k-chill that you might be using integrated with your sharepoint offering or SharePoint deployment next question was around pricing and I'm not going against specific here and then you can reach back out to us there's two main ways that our customers are consuming the coast of product today one is through our hosted cloud service cosine cloud which is targeted commercially towards the individual user up through 25 to 50 total signers if you're above 25 signers certainly about 50 signers then you're going to want to strongly consider bringing your own cosine central system on Prem or commercially it's a much more attractive offering slope cosine cloud just let you know start to 180 dollars per user per year and there's some add-ons for special cosine connectors you choose to use them okay I don't see any more questions so I want to wrap up today's webinar thank the audience for your participation and if there is any follow-up questions a request for this presentation material feel free to reach back out to a RX at FDA and ARX calm and again thank you for your time