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so with that it is really a pleasure to introduce kelly stanton so kelly is joining us from qualio and qualio is a trusted quality management software for businesses that are focused on bringing their life saving products to market faster today's speaker brings 20 years of experience in both the pharmaceutical and medical device industry she has been an implementer implementer administrator and users of many different eqms tools on the market and she's built several quality systems in her time she is also serves as an advisor to dozens of medical device and pharma companies helping them to adhere to the evolving regulatory landscape today she's going to be talking about the shift to digital and leveraging cloud-based quality management systems i personally have interacted with kelly in the past in a small company environment and can really attest to and appreciate what she brings to this space so kelly it's a pleasure to welcome you yes thank you thank you yeah this whole industry talk about a small world right um so we were just chatting about some of those experiences and that was a lot of fun so let me make sure there we go yay cloud-based quality management systems how many of you are on paper less and less i'm glad to see [Laughter] um it's it's not something to be scared of um going off of paper i realize it feels wonderful and and controlling and you've got your printers and your stamps and all of those things but you can really move a lot faster if you're if you're off the paper so so we'll talk a little bit about why going off of paper will make it so that you can unite your teams your processes data is much more available you don't have to pay people to enter things into spreadsheets so that you can do you know tracking and trending or data analysis and that kind of stuff and i'll give a few tips for migrating off of a paper system if that's what you already have a lot of practice with that in my in my career i have a couple of case studies i'll present some existing customers that are being very successful in the space and then audit best practices while that feels a little random um the whole goal of your quality management system is to get through your audits right get through your the regulatory paths make sure that your um you know your processes are well documented all that kind of stuff so that you can show them to other people so we'll talk a little bit at the end about how being electronic is really going to make that a lot easier all right so qualio um who are we uh you know i think a lot of people maybe haven't heard of us yet we're we're growing like crazy so we're a lean quality system tool we really believe in what's actually required by the regulations not what is everybody's interpretation of what else do we need to write down you know quality people love procedures down to that detail and here you've got to use this blue pen and you've got to write all these forms and you've got to have five other people sign it we came screaming on the market about 10 years ago and we really have tried to be lean efficient um and and fun quality can be fun um so yeah we we've it can i laughing it really can be i promise i actually had a customer one time who got done with an implementation and he's like man this is great maybe i'll do my taxes next you know and i'm going oh my god like okay yay um glad you think about quality and taxes together right there's there's uh some things you want together but um we you know we leverage a lot of our g2 reviews that's customers can review us our customers agree that our approach is is simple compliant and yeah easy to use so important that it's easy to use so breaking down the silos you know paper makes it easier to have silos right to go chase approvals around a building uh find different departments they're in different parts of of the building different parts of the organization um why do those things um in a paper-based system those are your only options really so we recently uh did a survey life science quality trends report swing by the booth later if you want to see the entirety of the data that we've collected it was really interesting so folks that are still doing things on paper are still spending inordinate and inordinate amounts of time doing it administration you know if you've got this piece of paper somebody is going to sit and take information from that and put it in a spreadsheet spreadsheet so that you can actually start to analyze the data have that data start to be useful so it was it was fascinating to me that there's still you know 25 to 50 percent of a working day spent on things like populating spreadsheets making reports you know quality control batch inspection sampling testing you know there's so much power in that information if if you can actually do something with it right so if you're operating on paper you then have somebody who has to translate that information into methods that make it useful so across industry uh 38 percent of people are still only using paper and spreadsheets to do that kind of work this is 2022 like that's just mind-boggling to me quality assurance auditing training documenting etc 50 53 of our respondents still spend more than a quarter of their working day just gathering that information and keeping track of it all uh so again uh in this day and age of computers and all the power of that information you can't unlock it if it's if it's locked away on paper i think our resistance to that though is based in the regulatory regulatory requirements right um and and i hear that a lot uh from more conservative customers are you know but when we did it on paper we had this control or we had this uh you know ability to to control the information or control the change to that information right because change whoo there's a scary word the regulators are really starting to realize that there has been historically too much of a focus on compliance manual quality control activities you know we if we don't write it down it didn't happen right that's one of the things we all say in industry all the time especially if you're a qa person and you're talking to someone who's maybe in manufacturing you did something you didn't write it down right now we can't show that it really happened so when there aren't tools and systems in place there aren't enough resources or energy to put into quality improvement you can't take your system to that next level if you're spending all of your time and focus just managing the system okay the system needs to work for you it's really hard to do that on paper so if 80 percent of the effort should be in improvements things that we're doing uh to to improve the product improve the manufacturing processes ultimately improve patient safety um if you're spending all that time transferring your pa you know your your data into a spreadsheet you're not spending the time and the effort where you should be on the improvement of the processes so in the journey to world class um you know quality control kind of that base layer across you know if you one of the things too i think people talk a lot about is is you can't um you know you can't test into compliance right um that the processes have to support the activities make those activities easy for your operators and that that really helps you get to that place over time where you start to focus on improving your processes not just trying to keep up with the baseline of documentation and and collecting that information so how does the cloud help us with this how does going electronic help us with these things well again so we talked about you know at the beginning that people you you end up with quality specialists whose whole job is just to extract certain pieces of information and then put them into a tool that gives you the ability to do that data analysis um if that's across a bunch of spreadsheets localized on people's computers or maybe they're you know in a sharepoint type drive or whatever you don't have a lot of control around the changes to that information or you know did you validate that spreadsheet i mean some of those kinds of conversations have to come into play because the information is just too scattered another way too with breaking down those silos you know in the cloud it's much easier to do things like have api integrations to other tools right nobody in any organization does all the work in just one tool right there's there's your maybe there's your learning management system and if you're doing manufacturing you probably have an erp or building monitoring systems you know you've got all these pieces of data that are scattered in all these other places so if you have a system at the center of that that could be the central source of truth and leverage your api integrations to bring those data points together then the people doing the job can work in the tool they know right one of our big segments of of customers is software's medical device those guys are a bunch of software engineers who use jira and maybe asana some of those kinds of tools they're using git as a code repository there's so much information that your qa team needs to have visibility of in those other tools but now i've got to work in five other places right as the qa specialist i have to go over to jira and monitor for changes or um or get or you know any of those kinds of things and so if you can leverage api integrations and bring all of that information together your quality team can do what they really need to be doing which is overseeing the pieces of work that are happening but your engineers can keep working in jira and and and being very happy in their world and your your warehouse folks they can keep working in you know their erp system whatever that is but there are pieces of those in that those systems those information that can come back to your quality system and and and have that visibility into all of those tools that your qa team needs to be effective a good eq ms tool is flexible configurable can match and enhance the company structure in the ways that you work you want that flexibility and a tool that's too rigid a lot of your older on-prem solutions and i have experience with a lot of those guys from past they're very locked down in the way that they function and because they're on premise solutions they don't you can't really adapt them very easily to your business either so you really have to you really end up either working with them and spending a ridiculous amount of money to customize the solution so that it works for you or um well i won't go down that rabbit hole there's there's a lot that can go wrong there cloud-based access from anywhere you know we're coming off a pandemic where a lot of us worked remotely or had to transition to that if you were a paper-based quality system you probably didn't get to work remotely or you had to have a scanner and you know there's there's a lot that goes along with that too so um in this world where we're outsourcing we're traveling we're working remotely all of these different things an electronic quality management system makes all of that a lot easier uh version control um wikipedia tools like notion for example you know it's a great place for a repository of information but as you guys know from a regulated perspective there's no actual control over that information who owns it how is it kept up to date all that kind of stuff so a good eqms tool obviously version control is is key and critical critical to those requirements workflows you know drive collaboration concerted action uh single sign-on making access easy all of those things are are ways that eqms tools can help but efficiency in those workflows that's uh that's probably one of the single biggest best reasons to go electronic with your quality management system so migration tips i have all this paper i have my processes they're all well documented now you're going to just upend that um so to get started ask the right questions as a search for a vendor it is amazing to me how often people are shopping for a quality management tool and don't know what they actually needed to do and i have a realistic expectation of what it can do and and it's funny because it could either scope creek because more people start to hear about it you know you're buying a qms well does it also do calibration oh you're buying a qms does it also do batch records um are those things really key critical requirements that you're after are they nice to haves so make sure you've got first of all a good team together good stakeholders document your requirements what are you trying to achieve understand what you're doing now and how you expect this tool to help you change that and a good vendor i mean of course they all want to sell you something but they're going to have they're going to have experience in this and it's going to be a lot easier to make those transitions if they've spent a lot of time doing that already and can can help you start to think about you know maybe here's a few other points to consider or things where people trip elect a champion champions change agents can help manage the cultural change of moving to a digital quality system they can spread awareness encourage participation secure the support of senior management internal traction buy-in you know all of those things should be somebody that people in the organization generally have some respect for don't give the job to the intern here go find us a new tool and and they're the only person who has the time for it but maybe they don't have experience in all the aspects of a quality system those projects generally don't always go well in my experience no paving the cow path you guys familiar with that term at all software is something software people talk about if we're going to make an existing process electronic paving the cow path is uh where you just take your existing process and now you move it into the cloud and you don't actually make any changes to the process this is an opportunity to make things more efficient to to really really look at the various processes as a whole and and and figure out how to make them more efficient how to make them easier how to drive engagement in your organization it's continuous improvement not just assurance and control um i did one of these projects once where everybody in the room was very very attached to the way we were doing it before and so we ended up making a lot of changes to this tool that we purchased in order to make it match the processes boy over the long haul that's been very painful and i have some friends still at that organization and they still struggle with these things because we made the application so custom that any time then the vendor would release updates we couldn't update um so that actually is a bigger risk in the long term than if we had just looked at the process and said is this really necessary to do something as simple as complaint handling doesn't have to be complicated but we had bolted on all of these other aspects like failure analysis and mdr reporting and all of these things became key elements of that complaint process so we tried to make the tool also accommodate all these other elements that weren't just complaint handling so to this day they're still using that tool but they've had to decouple some of those customizations in order to just do updates for things like security patches and stuff they couldn't do any of those updates case studies irresist came to us about three years ago they're in pharmaceutical manufacturing they have 75 users with us now they have an otc in market and they were paper based uh six of the people of those 75 people were qa um and they were really struggling to keep up you know people were spending their whole days just doing documents and so they were able to expand their quality participation across the organization from those six core people to really embed quality across all of their processes and so they now count 60 people as either qa administrators or in input type situations where they're overseeing aspects of the data generation that goes on there they're using our system to maintain documentation for hundreds of specialty manufactured therapeutics at this point so again a lot more efficiency in that and they are trying to recall exactly where in the world they're located but um they've been using qualio to complete their internal auditing and they're ready for an fda audit at any time now again so three years timeline right fda wasn't doing on-site audits so now that fda is back doing those things i think they're they're gearing up for that but the point being that there isn't a lot of paper to herd here so they know they're ready expression therapeutics i love these guys they are have recently built out a 43 000 square foot manufacturing facility and came to us right as that project was getting going because they weren't going to do anything on paper they were just no we're not we're going to go from from day one we're going to be paper free and so it's been a project to get their qms you know the base elements of quality systems like dot control training that kind of thing very simple um we were really able to free up their time and allow them to focus on their manufacturing processes because we helped them with their quality system processes so they didn't have to spend a lot of time writing dot control sops that was our all already kind of built in um but having all of that from the beginning meant that uh it's not going to be a transition for them later so instead of getting all of this off the ground and then having to change the system in a very big way they started from the beginning with going electronic all right so then jumping over to audits uh why would this be relevant to just being paper you know going off of paper to an eqms well you're always ready for an audit right and and so i can i can recall days of you know prepping the back room and the carts where we all you know we'd have to go gather all the binders and all the here's our sop binders and here's all the manufacturing process validations and having all of that stuff staged and inventoried and so we would spend weeks getting ready for an fda audit to make sure that we had everything at the ready right there well in the case of electronic qms it's already ready it's already staged you know there's there's no physical movement of all the stuff to a location that makes it easier to deal with um and and so so you're always ready you have access and and you can also um have some better control of the information as well um one of the things that we like to do because we get audited a lot by our customers as a supplier is have um you know the core sops everybody always wants to see you know we need your sop list and we need your quality manual and we want to see your your quality system procedures that's all already put together in our eqms and it's already tagged in a way where all i have to do is invite the user into our system make those documents available to them and boom there it is you know there was no copying them saving down you know everything to a shared dropbox location making all that stuff available right so if you guys have experienced some of that in your auditing of vendors um for me personally if they've already got eq if they've got electronic quality system or electronic document management at least in place the information flow is a lot easier and um the permissioning in the system should be sufficient that you can curate the content too so um you know if the the supplier or the auditor wants to see a particular set of linked procedures i can just add them right into you know their permissions i don't have to go again find it in the drive save a copy no you can't print this you know et cetera et cetera training records same story right a good eqms has all the training available you know they they look at the org chart which is also available through my electronic quality system and they pick a couple people they want to see training i can make those records available to them in real time once the audit's over findings are easily tracked you know you should have good workflows that make this easier we can assign out the tasking to the right owners for corrections so i don't have to get everybody together in a room you know it's like nope here's here's my kappa that's related to this audit finding here's the things we're going to go do assign it out it's all happening immediately no generating copies of forms or tracking the master form if it's a kappa for example you know who's got the binder today oh gosh i spent a lot of time chasing binders around you can reduce the meetings too again if you're not collaborating on paper we don't have to gather all of that information into one place people can put it into the system and into the workflow as they're working on it and then as the quality administrator the person responsible for that cap i can see it all happening in real time i don't have to have that status update meeting where everybody brings their notes and their binders to uh to the conference room so all of that speeds things up um i get asked a lot about you know well how much does it speed things up uh i'm not sure how easy it is to directly measure these things but definitely i can tell you anecdotally and i think most of our customers would agree uh makes it a lot easier all right q a time i think we have about uh got about 10 minutes what questions do you have so first of all kim thank you very much really appreciate excellent presentation i i guess one thing i'm curious is just what you're seeing in terms of your customer base how many are coming in um that are you know paper-based coming to you for a first electronic solution versus those that have been on electronic solutions and are switching over to you well that's a good question that's a good question i think sort of it depends on where they are in their journey um in in my experience i've seen i would say it's probably fairly evenly distributed with and certainly not in the pharma space specifically you see a lot more that they've already got paper in place it's it's harder to get further down the road without having anything right medical devices are a different story those guys will come to us green field right maybe they've got some design control files but they have nothing else from a doc control perspective so within that segment the pharma um we've seen it's amazing to me that there are still so many companies doing it on paper so i would say probably the majority are coming with some form of paper maybe they have a little bit of a hybrid system like they might have they've got procedures and things that they're managing still with wedding signatures but then they might have a learning management tool that they've integrated with so they have some training records that are electronic great good thank you any other questions that are out there hi herrera seneca what is your experience with uh other regulatory agencies like ambisa ethan you people with this type of software do they actually accept it or do they they do they do um it's interesting i think outside i'm finding that outside the u.s the regulators are actually more accepting of it than in the u.s and we have customers all over the world you know so we've got we have several um ins kind of breaking into that the asia market so singapore and some of those guys done a couple of systems under picks the the core elements are the same and so i think as long as you can you know demonstrate the control of the data the information the configuration those kinds of things i have not seen and i should knock on wood but i haven't seen any of the regulators come in and say no you can't be electronic i think i think having the good understanding of your processes and where the risks are associated to those processes and making sure that you've thought about that and that you've built because the software can do so much there's still people involved right so what pieces do you need to control from a procedural perspective versus what pieces does your software do for you making sure you've got a good understanding of how the combination of those things then meet the intent of the regulations i think when people do that i don't i haven't seen that it matters which regulator walks through the door hello irene i work for pioneer immunotherapeutics and many companies i think most of us we work with a network of partner companies whether it's contract organizations suppliers and the challenge that i have seen is about the touch points between quality systems internally you know and the touch the touch point with the quality systems of our multiple contract organizations and some of them may be on paper others maybe electronic but on a different system we use we validated adobe sign to approve dot paper documents they've validated so any advice from your perspective on those touch points and integration and how do you manage this landscape that is inherently not going to be homogeneous yes that's a very good question i think probably one of the first things i would say is if your sops are stating things like you will only accept documentation from adobe sign you have already restricted yourself to working with only people at adobe sign you know there's an appropriate level of detail to demonstrate control and so the more appropriate way to write that would be you would accept you know compliant electronic signature generated as long as it's generated in a compliant manner and do you need to go so far as to document which ones you feel like are compliant like that that that's a rabbit hole of of of control is what it is and so if we if we back away from that rabbit hole and say look what's really important here you know i mean last time i bought a house i signed everything electronically and it was it was a system i'd never heard of right buying a car with the bank during covid same thing right my bank was like well we've had to implement this new electronic signature methodology because we're not letting people come into the building right now that's a lot of words for make sure that your procedures are appropriate for where the risks are if your vendor is using a validated electronic quality system to generate their documents and that's what they're providing to you then in your selection of them as a vendor part of that was you know yes they they have a system and yes it's appropriate and we have or have not heard of it and if you feel like that's really a risk for you then spend the time in that audit to dive into that system and understand it so that you can then accept their documentation and not you know the biggest waste of time would be to pull their documents that they've already signed and approved and now you're going to put it in your system and you're going to sign it and prove it again really like that that's not a value-add in the big in the big scheme of things and and so i think you know that that slide about spending you know we spend way too much of our time focused on that level of detail there's a person and there's time and so you've dollars tied up in that exercise at the end of the day you accepted this vendor and said yes they are sufficient to do this job that i've hired them to do those details are not we shouldn't treat everything like patients are going to die right that's one of the things about risk assessment and this this would tie into that right what's really important here you know these are the things that mean if something goes wrong patients are going to die or have to recall a product everything else underneath that you can start to leverage leverage your quality agreement with them let you know your supplier audit they're sending me documents electronically do they have the processes in place so that i know that the data they're sending me that they signed is the integrity is there document all those things through your vendor qualification process then you're good and make sure that your procedures are written in ways that allow you to accept that information because you have all of this other stuff in place this is yes i trust this vendor does that kind of make sense yeah all right well i'm sorry to cut us off here so kelly again thank you very much for the presentation i know um if you've got more questions head to the booth quality's got a booth in the ex expo center so head to the booth you can answer your questions there right now what we're going to do is move into the one-on-one sessions again networking and it's also a happy hour so it's time to grab an afternoon drink head to the one-on-one sessions and then we will close the afternoon with the plenary sessions thank you all you