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you and very much for attending all Sultan's latest webinar my name Robin Henry I'm Director marketing for ultra consultants and I would like to welcome you to today's presentation on electronic badge records for the biotech and medical device industries and today we're joined by our friends from merit solutions for this presentation or we get started just a few guidelines for this session the phones are muted for the duration of the presentation until we get to our Q&A period however at any time during the presentation you're welcome to ask questions and you can use the web see you a or chat features in order to do that so just type in your questions or your comments chat and Q&A and we will Samara on our end and be able to rest them during our Cure dark Q&A period also during Q&A if you'd like to ask a question directly and I can unmute your audio to do that you can click the rayon button and see that I'll see that on our end and I'll unmute you and you can rayon you can ask a question directly over the phone you can use the positive or negative buttons B on the right of your screen to maximize or minimize your screen as necessary so just bring our agenda for this afternoon's presentation I'll provide a brief overview of ultra consultants and then we will get into our presentation in demo from merit solutions and we have invited just Richards and Alexander Ivanovitch to to give that presentation we will be you a day and have a brief wrap-up at the end then before today and select to provide you with a brief overview of ultra consultants is a vendor independent consulting firm and we're totally within our alliance interest we don't sell or promote and related ERP software services but rather we offer objectives ERP technology the expertise as well as business process management expertise for the Mac shirring and distribution histories exclusively we serve our clients throughout North America as well as companies with global operations and we've been doing this since 1994 headquarters are located in Chicago being being vendor-independent the consulting firm means two main things the first one is that we are your partner for guiding you in your ERP vendor education and selection and swear we help you get to know yep the ERP vendors and the implemented practices that are best for your company every project needs and then secondly we'll see your partner for how to discover how to make improvements throughout your organization ERP and enterprise technologies and we do through our business process improvement services which which we call BPI so our areas of expertise are in business process improvement as well as EP implementation management services as well as the ERP technology selection and engine management to help you improve your business processes we simply do it with this basic equation what we do that we look at the possible ERP systems that on the pivot for your organization and industry and for your business and add to that our business process improvement services and methodology then and equally important to those two first two is to incorporate our industry experts our methodology and the care we have for your project being a successful one of course and each other they make up the business performance results that you're seeking from your project in our value proposition and we have over 250 clients that have used this kind of guidance equals selecting and also implementing their new ERP system so found on our clients these we serve in our services history as I meant previously we work only with manufacturing and distribution industries and clients within those industries and you can see that in our list of verticals that are in the pie chart and the list below so we have over 250 successful projects for now for manufacturing distribution companies the size of those companies range anywhere from about 25 million up to two billion dollars in revenue and within those projects we've conducted we've worked with 20 different ERP vendor and European vendors and system implementations and for our relationships with erp and enterprise software vendors vendor-independent and with relationships with over 40 ERP vendors across tier 1 tier 2 and tier 3 categories so we categorize vendors according to the size of companies that they sell to and we maintain our relationships with all of these vendors in a variety of ways we do this through our contact with vendors during our client engagements of course we conduct monthly vendor briefings we have briefings with partner firms from for the vendors as well as partners that specialize in an industry or specialized with the vendors product line - so we all know briefings with each vendor and we attend as many of their shows and conferences as we can to keep ourselves and our clients educated on this company on their products and what makes each company competitive energy market and we also have a dedicated vendor analyst here at Ultra who mates and maintains our unique content and also our leadership on each vendor as well so w of ultra and i'd like to move into our presentation from resolutions and introduce today's speakers van ruijven Eric and all Josh Richards and touka senior consultant that merits and he's been working with Microsoft Dynamics AX ERP since 2004 he's over 12 years of experience of year be consulting helping manufacturers and heavily regulated companies transform their business with a key solutions include organizations in life sciences food and beverage consumer goods services industries so he'll numerous roles while working with Amex ax e are pieces including functional consultant application consultant business analyst product development solution architect and project manager as well this is excuse me my mistake Josh certainly does not work for a procore he works for merit solutions that is my mistake in my deep apologies Josh he's responded merit for helping organizations identify the process and technology improvements that will help them transform the business and he has more than eight years of experience supporting FDA greater organizations through tries transformation initiatives professional evaluations on through ongoing support and it first transferred the the presentation over to first Josh there you go job I know can you see my screen again all right thanks Rob for that introduction today we're here we want to talk about electronic bed records first time I go through just two quick rundown home merit solutions is who we are as a company how long we've been in in business and then get into the meat of this presentation and that's electronic badge records so it is a global consultant and systems integrator for mic dynamics ax ERP and then we also develop mobile solutions really for any ERP system we owned it in 1999 as a consulting firm with with manufacturing experience our founders and initial consultants all came from really heavy manufacturing backgrounds around 2003 we're approached by one of the big four consulting firms that to help them establish and build out a life sciences consulting practice based on the Mushaf Dynamics ERP systems so since 2003 we've really been developing solutions and implementing at end systems for fda-regulated companies from nearly to document management and now getting into related solutions for life sciences companies for offices across the US and in Europe we have a 60 practitioners consultants developers who are responsible for supporting our clients needs and today some of our clients include companies like the Jackson Laboratory can't--no corporation Pharma cyclic super-nice pharmaceuticals and and us they're going to talk about electronic batch records as most people on the call are aware when are suitable or biotech company makes a batch of a product the FDA acquires that they maintain a document known as a batch record and that record includes all the details of how that product was made when I did what lots of raw materials and ingredients are used who proved it who signed off on it and it physically did the work or made that product the batch record must also show that any DEA shion's that occurred during the manufacturing process we're investigating did any corrective or preventative actions were documented and implemented importance of these requirements is that de Lisle consistent in uniform batches to be made that that meet established quality requirements and problem does occur after the batch gets to the cygnets to market batch records can then be reviewed in an asset potential issues that may arise unforunately what what we see is that many early-stage and rapidly grown company today still rely a pretty lian paper-based processes to document every step in person at apply with GMP or FDA regulations there are traditionally every product has a binder stored somewhere in the office in which that batch record information was stored that's where you get the quote at the top we produce two things paper and drugs obviously there are many disadvantages to this approach you have increased operating cost you have higher risk slower and inefficient manufacturing processes and it's the visibility that you have into the data that's stored in those documents so today we're going to be talking about electronic badge records which are essentially pneumatically generated an electronic version of those traditional binders that that companies have but let's first discuss the main benefits of electronic badge record systems and autom across the seas some foremost at the top PBR somes improve process accuracy and consistency so unlike people unlike you and me automated systems do a program task exactly the same way every time so what we may have bad days we have attention lapses we forget minor details we don't get enough sleep at night automated systems aren't the same and they perform the same way each and every time EB arsons also increased productivity because they perform tasks in automated steps instead of manual processes which also frees your people up to work faster and smarter an electronic batch records reduce cycle times because they enforce the consistent ocean of manufacturing steps while providing a real-time view of process and deviation data set the the time associated with affecting and correcting and documenting deviations in the manufacturing process with the various paper documents is pretty much eliminated EB FM's also reduce compliance costs because they they can imagine eclis capture compliance related information and they can properly organize it and then they resent information in a way that's that's easily and quickly accessible a friend pointing biggest cost of these manual and paper-based processes is the people s company's time by manually performing tasks that again and should be automated and we owe that that time means money so o use let's take away some of the time required to do processes and they also eliminate the the costs associated with printing reviewing storing and back in retrieving those paper documents looms also increase an organization's ability to scale so when you grow you have increased volumes going through your business processes and invasions in those processes based on difference of customers different types of Plex or order suppliers so the risks of paper-based systems are far more dangerous and inhibitive to rapidly grown companies because of those reasons and the eb r systems improve decision making manual and paper-based processes store data and it disconnected and difficult to access manner and because it's costly to gather that data many companies decide to operate without it which the decisions that are less optimal still still take time to make so their time delayed as well so the following survey results on the screen from the menu churning and rice solutions Association on average improvements with electronic bachelor systems here's the proof on how business performance is improved with EBR systems you can see that it helps companies reduce costs it's be time to market the automate compliance and then they have better visibility from the top floor to the shop or and you can see the payback periods range from three to twenty five months so there's a pretty quick payback as well for implementing electronic batch record systems when we begin looking at at Meriton our actual EBI batch record solution I want to first briefly talk about just Microsoft Dynamics AX the underlying ERP system that we've extended with our Mac's life offering Dynamics AX is Microsoft's flagship ERP solution for medium and global enterprise it has core business functionality and then deeper history specific capabilities for for financial manufacturing distribution serves in public sector companies didn't isn't ready a dynamic ax demo so I'm not going to get into all the the core functionality of AX that you see on the screen but barely I want to convey that that decks ax is consistently ranked by analysts like Gartner as an indicator and visionary more than 20,000 company they use Dynamics AX so use ax as the platform for our my life solution we obviously believe it's a great core your custom for companies come that that one increase visibility prove productivity and efficiency or really gain better better insight and data into their company out of the box ax does not meet many of the quality and compliance requirements that are levied at daizy's Sciences organizations so we went into our math life offer life is a pre cured validation ready Dynamics AX solution that can be deployed on-premise or in the cloud Achan civ business models industry documentation implement templates and even some integrations with third-party supply chain partners max life is a pre compute solution and I can basically be din and use out of the box or it can be somewhat of an accelerator for complex or global deployments so we use max life for areas like financials HR Payroll but maybe your factoring process these are more complex and we're more unique configuration so we can get into the to the the unique configuration for those processes without using the out of the boxes the max life also adds new func allottee and extends Dynamics AX specifically for regulated organizations so it includes funky around contract manufacturing orders and 21 CFR part 11 compliance training and certification tracking life and retest date management CAPA reporting mobile saloon development of this but we're really here today to talk about olymic Badger Records and what what we do with electronic badge records so max life ironic batch record functionalities is designed to give life sciences companies an electronic environment that occu ments the execution of entity any perceived new process and you formula or recipe it's compliant with 21 CFR part 11 regulations so the main ERP system that we talked about demyx ax it already has a lot of the detailed information on reduction of certain batches it knows the nation on all the components that went into attach all the badge numbers who posted the consumption records accorded all the quantities that were produced who did the testing and all of that so with max lifes evening finality users then have the ability really to quit gather all of those details from ax so they don't need to go up the time-consuming and manual process of hustling those documents manually as most companies do today that EBR document is created initially as a as a Microsoft Word document that doubts through a fool I came out lifecycle management process and clean I made it work for audit trails since important archiving max life then extends them the Microsoft SharePoint based approval and electronic signature processes sometimes the approval of the the final version of each EBR so when final approves given a PDF is generated that includes the EBR data as well as all of those approval signatures and then that that PDF then becomes the permanent EBR document for the bench this again is available electronically so there's no need for paper printouts or cabinets or anything like that you have it all available readily available within or your business systems that you use every day I might like to hand over to my colleague Alexander who can get into the actual Dell and show you what max life looks like and wisdom does so Alexander I'll go ahead and pass it over to you thank you can everybody also for my side my name is Alexander and I'm going to show you what the ABR or the electronic batch record looks like from the ax perspective to be a real demonstration of the electronic backward record feature so I'm going to from the Cork's which is in this case the production control module we're going to do first things I'm going to the list of all my production or batch orders and I'm going to start from fetch so let me briefly rate one production or for a product of red paint in this case I created a brand new brush in order let me a few details about this we'll go to the edit mode and I would like you to pretension to to one of this batch order header we just SharePoint URL which is found one the little checkbox below which says create web folder I mark the check box with the size that I wanted to include this batch folder to my electronic electronic batch record system what happens now what really happens in the background is that a batch process creates the SharePoint URL and later a folder on SharePoint for this particular batch daughter I'll not wait until my process runs in the background so I will cheat a little bit and the periodic function which says create folders for web document management as you can see it one up for batch process all those ran into manually I would have to speed this presentation up but normally it runs in the background every 5 and goes through operation orders that of this little check box mark it already created life on my spear point which teams reject like a placeholder holder for my electronic metric the option of course and this strongly depends on Dunn's of our clients and we'll discuss the implementation aspect a little bit later is that this little checkbox is turned on by default so basically each production or batch would are created I'll have actually get it a library and SharePoint for electronic battery is click on this little icon here leave me to buy up a specific library just for this bachelor and as you can see it has the same number for that order that I just waited so it's really easy to to find the specific information that we need for any particular bachelor in the system so in my case this is a bachelor 44 and the lottery is called it's going to ask batch record for batch point it is um it does not need documents but real ki and it the we'll see how it changes as we progress with a logical of our batch plus Madhavi this brief so we can add it from the list page which is more convenient in this case this perpetual has the status created I initiated fifty four units of of this particular product I can already see from them and the list page or the wrong hand side I already have a button upload electronic batch records to lose a little bit longer so I do not see older lettering but the hint of electronic batch record carefully what will happen button right now oh the big batch order is just created and it does not have any transaction all right it again what I get is this little dialog for an electronic switch records on SharePoint and as any Telex in a acts it can be a set up so that the processing is turned on that periodically a real sense a batch process it gets automatically grab the information record against this Bachelor upload them to our GTR I'll do that for Footwear we'll go with a manual approach for in order be aware of all the details so I run this little prop and give it a few seconds to process a request my message says the document is successfully uploaded on the ship our clip I will go to my SharePoint Navigon library which all the electronics touch the batch record for my bachelor style of paste and this can I have just a handful of here each other represent in your library food they will turn into electronic batch records I see four minutes ago exactly this folder for the r44 three alright that it was empty oh I have a Word document we can create it and this is actually our electronic batch record the first order and it's going to be progressively updated with information as we progress with the lifecycle of dispatcher let's take a look what it looks like sorry oh it's basically just a hat no information of that as you will see how this poor document is opted and changed so just have a header I will close it and if my basically strongly depends on how our clapper rate and what are a tiller requirement a two approaches for processing EB we call a partial date of the EBR in which ensues rich particular documents for lifecycle of the bachelors are relevant for they are those particular don't participate in rural building of the electronic electronic that track their approaches which the one we call global is every transition transaction recorded or both by order they eventually uploaded to the EPR ideally or during the batch processing that I just a particular demo I will show you the partial approach that means I will go one by one one activity at the time and progressively EBR with relevant infamy some let's move on then let me start this natural skip a few steps of the life cycle such as release schedule etc and we'll start this production so see this now to start this you nae axis allows me to funds action against this bachelor order so I will move to my ten particular case of the picking place that having consumed Royals or components of the finish good is rated automatic back click block as you can see is just one component out of paint please if you forget I will gellick those two simple although they are not here to discuss amateurs as you can see this particular button update the electronic back or record of available for my beginners I clicked it again manual or automatic Express you know preferences let's go with a manual approach or demo that actually does now its operation cleaned in this picking list to the electronic back by dragon see it is a test fully uploaded to the the process in ax can be that I can have multiple picking list or I can have this picking list with multipliers of infer all turn components and then a few minutes or a few days later assume the rest of it so the turn of the approach and it buses that are Klein has is when at which particular point we will have to to up the electronic electronic electronic batch record sorry we'll help our recommendation is that you electron upload should turn at the end of the process but again pretty awesome as different requirements so it's up to them to decide when what particular point in one so what happened I believe click upload a link back checkered I can see the same word document between us saw a few minutes ago changed have another better added to the document which as big list sure no in X page I have the speak English information added to electronic electronic Patrick now [Music] information the EDR is actually contou whatever is contained in the standard ax is just as if we ran the pick list report from our standard of a X and if we defy the output of gender-based English report it will also be much it young so just that in mind it to be progress because the few different reports added to the EDR as we continue because some of them are out and some of them have a modified layout and it will be visible in the EBR well go ahead and move on with the life cycle of my ventured DVD for can be very processing my record or job card in which basically report there is our operation formed during the manufacturing process ticker case the out card is not automatically created so I will quickly create just a real operations for instance the operation 44 say well it took me 10 hours to to process particular operation and opposed my you the same story as where the picking I can have multiple cards if job card [Music] - no my ticular process is at which point I will want to upload my electronic electronic batch record after every operation reported or the end of the process with all my operations are reported against this venture so let this particular point we uploaded close my heart and see what happened to my dad so how did right after the picklist port proud Cardinal lesbian about the Eurasian consumption in okay mom the production cycle is now over and I'm reporting by production is finished in X I can do it either through the general call with what is finished or through the process I will create the journal in the end so it doesn't really matter so it is intense the job I reported to good quantity of 54 I am I am that's your sister report is finished and it's what I created I reports journey I will for the third time I can report a finish of the entire video it can be a negative product in which I report is finished Marshall quantities and each time I can choose whether to wait till an hour to upload electronic bite record I generational and one thing can each Journal that we saw here in the process to be pressed automatically we had a clean but I don't have to do this manually our document [Music] the Finnish journal that's report with all the English gains in tender production batch report if we - these reports also be reflected in electronic batch record I know what I would like to do [Music] transaction type that could be recorded against a match and be captain the electronic match record I will pull a fall order against my know by chest what I just made I will tech densities find fine the quality or I will just really go through the whole not wait time on this let everything went well all it is acceptable and I want to frame the effective analysis of for my sestra so create a new way and particular for the high permament to use the electronic signature I had this process regime of all the transitive you so do business demo shows a significant Alice's to be electrically sign this electronic signature is the standard ax electronic signature and it just leverages that ax features next slide also has the electronic signature feature which is before another webinar [Music] are more more more complex options optical person signatures etc and this is standard a electronic signature option and Marty's so I got it now I want to add my certificate of analysis to the electronic badge record the same you seconds get it uploaded okay see what happened to my duck what I said that idea and Ohio certificate of analysis the heaven the information for my testing of the densities of path and everything there that's the time of my edge order once again button that our client can say well I don't any people broach what I wish is that just what the batch recorder is complete when we yell we didn't we yeah coefficients against the batch order then I will just upload PL OS batch record so what would happen then I would basically go through the entire lifecycle that's a few hours or days or week and everything is complete I would just run to the upload electronic batch record and pull all that from the German tation all the transactions recorded again this batch order and create the same communities we just saw so this leads me to a few things regarding the initial approach I'll be like electronic back let's record so from our experience well read another two clients with the same requirement of guarding the EBR in content way of collecting data at the moment of column data for the EBR so we listen carefully the needs of our clients by a point which particular documents need to be routed in the e BR and ler the eb our system to fix outlines me and now companies are the same and we have really a variety quirements regarding the ER we something needs to exclude certain directions from the ER were to include kind of production to atomic electronic that tracker such as a kappa or a journal America recording engine so we will need to be carefully - well wine tree and it also applies to a electronic chair under a shoe I'm sorry model document that I just showed you need to be electronically time or Hayes's each document needs to be electronically signed denied that the electronic signature is for instance for instance needed for the big list implies that the weekly report of the box a X or optimized report I used on the client meet needs to be stated with the field to include the ironic signature information and what I mention during this demo the customization of standard reports is so automatically included in the electronic electronic batch record a pip or or content we are done with well how about changing this electronic batch record can start another process which is not the topic of this particular webinar and that's the workflow processing or the lifecycle on the point of this particular document well can be signed by multiple persons that can be tested a SharePoint engine an engine a specific location where you keep electronic records many of testers that Josh just mentioned in the open of this webinar so I would conclude my part of the day come on and I am open to your questions I will silver control me thank you I agree more and three share my screen thank you again and also Josh thank you very much as well so mister view of our agenda so far we of course had the introduction by me of ultra consultant center brief overview of the company a terrific presentation demo from both Josh and Alexander on electronic batch records and now we're going to move into Q&A so I know we had a couple questions come in from and you'll have to excuse on your NTPC some gray boxes just me opening up my windows here see if we have any question so I know I had a couple questions come in from from Judd price who is our vendor analyst here at Ultra and there for me while I get to the the chat window back up so I can relay the questions to you Alexander and also to Josh so to our audience too if you have questions please send those in you can use you in a or chat features and I'll see him on my end and we'll get to get to them away and I can also unmute your phone if you just want to ask a question directly so you can do it that way as well by rate by clicking the raise hand button on WebEx all right Oh so from Judd Judds first question those with integration capabilities with standalone mes systems what yes systems does Merritt have experience integrating with first question country you did you hear that what I was uh um you know my laptop well but recently I have regarding a me integration you can help me with them with that as well not really Gordon I don't want to give you the wrong information it's not a problem I would like to circle back and the later with this information we had multiple vendors for the es mes integration for for several levels of even three level and the just the shop floor level but the vendor names I would really like to come back to you with with the details later Turk let me thank you again the judge the question was what does implementation look like for a company going from paper-based to e BER may be a particular data transfer so ask the question is what we is just a clarification is the question what do we do with the existing paper record ah traffic onto EVR or you can end it all on you judge you anywhere which is that question directly just that maybe provide some questioners that's fine that sets that basically was asked again just how does that look going from you know completely paper-based system to say BR um you know what cool the data transfer how does how does that happen well two aspects to this first we have the existing historical electronic batch records which are which are in those that are now famous binders on shelves [Music] can be a different depending whether the corresponding orders are like imported interaction not at the beginning of the implementation sometimes we simply don't import the old-time dispatch orders reacts when we started implementation so no point of transferring those Abused as well because they don't have a counterpart in there so we however import the members of bachelors to ax which is not so common normal our clients keep their all DB are in your whether on PDF micro films or whatever they choose to do all right their material but if we if we do moderate the old and the auditors new informations we simply have the the part of the data migration we could yeah corresponding libraries or folders on the SharePoint and sign manually transfer to PDF the corresponding place so I start recklessly and as a second part of the equation we speak careful with our asking details about what exactly the content of their future electronic badge record and how do they want to write them sure the live with a action then Taylor as I said an EPR to capture the sectional data from the better man but the question is on the more on the data migration of approach whether they will or will not migrate the mystical information along with their the data migration okay one quick question from me Alexander what about electronic signatures how do you how do you deal with those well each Oh [Music] so during a acts configured to require I have a lot of electronic signature so we leverage the sender the actual electronic signature framework which are relatively simple and it requires one to sign the occurred at point whether it's at the cream of the record or specific update of the record meaning change the value of a particular field in the record quite simple and straightforward and sometimes it just just does not fulfill all the requirements of ourselves as a part of its life we have a mic splice electronic signature which is as a set a very interesting topic for one of the future webinars where have multiple diners different points in time and we have a much more options to sign each document using the Maglite electronic signature which I said is more diverse and wards operated than the standard 8 but basically ever heard that eNOS even every field change direct third killed by or electronic okay I don't hear the questions coming in from closest grains in distress on with a few final words and thank you again for those responses a few final words on information and resources that you can that you can leverage our additional information as you see their contact information if you might contact Merritt solutions Josh was our initial speaker today and his email addresses there Jay Richards at Merritt solutions comm if you have questions about all Troy you're welcome to contact me Rob Henry at our Henry and ultra consultants comm hours resources for further education investigations and merits hidden also algebra we have tor centers and education centers and which I'll get to in just one second and as far as recording for this webinar the recording of this webinar you can access this record and request it just by contacting Annalise member here at ultra Annalise is our marketing coordinator here at ultra and yell her and you can get access to this recording you can share with the rest of your organization as well as far as additional resources Merritt has a terrific resource center which is on site underneath the resources tab and they have site papers dedicated to life sciences as you see in the upper right hand corner few of the titles there as well as blog entries that are particularly - life sciences as well so just go ahead and visit their site click on the resources tab you can get to so you can get to those right away and we have our Asian resources among them our recommended readings which which are our white papers we all have blog as well as well as a listing of upcoming events upcoming webinars in the next in the next couple months all to mention that we do have a very robust list of on-demand webinars which are recordings of our past webinars so if you'd like to look at our past webinars we do have we do additional topics that we conducted on biotechnology and medical devices particularly document management and quality control we did some webinars on that earlier in sixteen in late 2015 I also did another webinar on electronic electronic badge records as well both so those be found on our on-demand webinar page each and all you need to do is grab a page you can scroll through the list of available webinars look at the synopsis the description the presenting vendors and if you'd like to request a webinar usually to quick request that particular webinar then you're taken to a forum where you provide your your name and your contact information select drop down menu the webinar you like to what you'd like to access click Submit and our people on our end will get word of that and we can get you that that recording right away so that's how you can leverage the occasion asset here at ultra and air lucien as well so I thank Alexander and Josh for a terrific presentation day for joining us and putting in the hard work of preparing those materials I want to thank all our attendees for joining today thanks for taking time on your busy schedules to do so yeah on behalf of ultra consultants I like to thank everyone for being here today and hope you can join us again for another webinar in the future until then thanks everyone have a terrific day and good bye bye