Are you grappling with the complexities and high stakes of migrating to the cloud while maintaining data integrity in regulated industries? Join us for a captivation roundtable with experts Monika Andraos, Rina Nir and Markus Roemer where we delve into the realm of effective strategies tailored for your unique challenges while navigating the shift to cloud based services.
🔍 Key Takeaways:
✅ Understanding the Complexities: Explore the challenges and nuances of transitioning to the cloud within regulated industries, and how these complexities impact data integrity.
✅ Best Practices vs. Good Practices: Discover why “best practice” is a myth and how adopting good practices tailored to your organization’s needs can foster resilient systems.
✅ Enforcing Guidelines: Learn the importance of proper implementation and enforcement of guidelines to uphold data integrity standards, even in dynamic cloud environments.
✅ Building a Quality Culture: Uncover strategies for fostering a culture of data integrity and quality within your organization, empowering teams to uphold standards collaboratively.
🤝 Why Attend?
🔹 Gain First Hand Insights: Learn from industry experts how they navigate cloud shifts effectively while maintaining data integrity.
🔹 Unlock Growth Opportunities: Position yourself and your organization for growth by leveraging expert guidance to address the evolving landscape of cloud transitions and data integrity.
🔹 Stay Ahead of the Curve: Stay informed about the latest trends and challenges in regulatory compliance, especially looking at AI integration accelerates, to ensure your organization remains ahead of the curve.
🎙 Meet Our Expert Speakers:
🔹 Monika Andraos is the Founder of Dunamis Compliance. She brings to the table a decade of experience in formulating and executing strategies for data integrity assessments and remediation, data governance, risk management and CSV/CSA within the pharmaceutical sector.
🔹 Rina Nir is the CEO of RadBee Ltd. RadBee helps medtech and pharma companies leverage the Atlassian tools to achieve regulatory compliance and operational efficiencies. Rina has supported many regulated teams through their Agile transformation and as they adopt DevOps practices.
🔹 Markus works as an independent consultant and auditor at Comes Compliance Services. Since 2008, he has been working as an ISPE ambassador for the DACH affiliate. In his current position as Managing Director Markus is in charge of consultancy services for IT, ISPE GAMP 5 SE, eValidation and PQS compliance.
#Regulatory#Compliance #DataIntegrity #CloudMigration #AtlassianJira #QualityCulture
Hello everybody and welcome to our webinar of today a new month a new webinar from redbe today we will be talking about mastering data integrity and everything that comes along in regulated Industries when we want to make the jump to Cloud today although I just said it’s another webinar from
Redbe we will have kind of another format normally you know we are very much Hands-On and presenting you what we actually do with our partners today it’s going to be kind of a jam session where we discuss stuff where we look into different opinions and where we try to
Give our knowledge to you over this platform and um no as usual as per usual I have our CEO of rby and the project manager of Sher snapshots for for Confluence with us Reena but also our illustrous group is uh joined or um completed by by Monica Andre she joins
Us from dams compliance and she’s all about formulating and executing strategies for data integrity and last but not least we have Marcus rumo with us he’s the managing director of the consultancy CCS Comer compliance services and he will have a look with us into his vast knowledge of EV validation and pqs
Compliance with that I want to hand it off to you three to quickly introduce us and why why you joined us today maybe Monica ladies first what brought you to this table what do you want to share with the class today um well I want to just share what
I know I think as an industry we we may be focusing on data integrity and we maybe need to take a step back and reverse engineer how to get there and so um yeah I I just want to share what I know and I think we can we can all learn
Together thank you Vina yes so I’ve a a my bread and butter activity is to help Pharma and medical device companies to use a atlan platform for a software development life cycle and to do that I I try to keep my hands on the pulse with everything evolving
GMP and data integrity and those type of areas and I I’m so happy to have these two experts here because I would be able to prove them with with questions here the latest news and somehow see how it is all also related to the implementation projects eventually and Marcus what brings you to
The custos group thank you so much um I I try to complete Reena and Monica uh and and I need people coming from the technical point of view and from the Practical point of view because I would like to represent today a little bit the regulations and the standards the best
Practice stand standards and so it comes to data Integrity um which is a fundamental part of computer system validation there’s no need to separate that we do that together together with rea cool Solutions I can already say that if we talk about EV validation that we get rid of paper based processes also
Production processes or laboratory processes to what we call it here now in the session e validation uh to use tools like uh for example ISB gam 5c Edition uh is is really uh strengthen that view which is called enabling innovation um and also to to have um a very good
Overview of the things what we do how we do that so it’s also methodology and methods and um I think we have big challenges and this big challenges need to have a team approach and this is the team of today that we have representing different core competencies and we need
To solve the the the the new challenges that we are facing now that you know who you’re talking to today and who I will be talking to today I also invite you to use the chat either on LinkedIn or on YouTube wherever you’re joining us and put questions in
The chat and I will pick them up and ask them uh when they pop up in my little window on the side um but talking about question let’s get right into the meet because Marcus you uh quickly touched on it with um the validation process and all of you are all about regulated
Industry in one way or another I think if I’m informed correctly you all have a background one way or another in the farma industry very much a um we want it to be safe I’d like my pills to be great and uh regulated I want my devices to be great and
Regulated if they are or should be um aiding me in my health so there is a I want to say a natural conflict between the Innovation that we’re looking into and everything we hear about what’s going wrong in this big vast place called the internet um and
Cloud in in a bigger sphere um Marcus from your experience because you work a lot with the Innovation and and you told me before we jumped online because basically your um your emmo is all about killing the paper is King mentality right so what would you say why do we need
That shift but also where are the problems and challenges that companies run into okay uh why we need that it’s I I think a part of that is um the the general um costs of production and and uh also um Labor uh work um so um these
Are the things that get expensive um I sometimes I I go very far with that also I must say um in maybe 25 years we will be 10 billion people on this planet and if we want to support all the people with the right medicine and we that that
Should be our overall goal we must change things uh regarding the supply chain uh the the efficiency how to produce that um and I think it’s if we would say that it should not be too much today but there’s also an ethical aspect behind all that um secondly um what people the
Human being in general does not like changes if you go into Supermarket you will see a lot of things they um make things new new recipe the people buy it or New Taste sometimes not for Coke and and this very classical things um and but people do not like changes yeah um
But change you can also say chances right um and um people hesitate uh to to change or they they would like to everything could approve around them but um they they do not really be part of the change and we do uh dramatic changes I think it’s also not going too far away
If we say 5,000 years we changed from Stone to paper and now we change from paper to um um to electronic records or electronic processes workflows and so on um and in some companies I remember one colleague of mine 30 years ago who started to do computer system validation
People needed to be trained to use the PC Mouse right and now we should learn all that digital software uh artificial intelligence as a service Cloud stuff uh in two years and I think that’s the challenge so and I had a lot of um conversations together with Monica about
That how to bring the people on board and you cannot like in a military way um say the people you must do this change you will fail you will fail people are working since 20 30 years with their Excel sheet or with their paper based processes and somebody’s coming around
We must do that everything new and I think it’s um to fight against the fear that that the people are not angry it’s a chance it’s it’s and basically you must do that to to be efficient um and it goes all to our costs and to to the
Also to how how much labor force we really have um and so so there are different aspects I think um resistance to change is the English word I would say and this is the biggest challenge that we have so what can we do in that area to work with that how can we
Actually get past that um Monica what’s your take on that I think it’s probably the answer to anything and that’s being an organization of learning I think there needs to be a sort of like organizational agility and this like this curiosity of you know how can
We make this better what can we do what can we learn we can’t be afraid of making changes and we can’t be afraid to do things differently because this is what we know and this is you know what inspect what passed inspection last time and we must stick to this we need to
Have confidence in our critical thinking ability we need to assess risks and we just need to we need to learn and we need to keep up because if we’re not keeping up then we’re setting ourselves back um if you use the example of you know the production equipment or
Anything that you have right now it’s getting outdated by the minute there’s hardware and software obsolescence the vendors are not going to maintain it for you forever so we need to get ahead of that we need to put our monitoring in place we need to see you know what’s out
There what can we be proactive about and bring into our organization and take our time with it doesn’t need to be rushed because again again you’re being proactive you’re taking your time you’re learning um and you’re slowly going to bring that in and implement it and then
Move um I think that’s one of the biggest challenges we have right now is things are being outdated Hardware is being outdated the software is being outdated things are running on Windows 98 and then we just keep it keep it keep it until whoops now production is down
What are we going to do oh go find this go find that get the system doesn’t matter it can be here the quickest we can’t do that we have to be proactive we have to put our monitoring in place and see you know what’s what’s near its life
What’s near the end of life and what what’s out there what can we do um we like I said we’re used to our old things so it’s like we’re used to having a bike or we’re used to having a horse and buggy what are they selling right now
Cars airplanes motorcycles we have a budget and the airplane can be here tomorrow wait guys we got to we got to prepare for this is our organization set up is our infrastructure set up for an airplane do we are we trained are we comfortable most of the time we’re not
Comfortable but we have an airplane because our system is broken we just have to use it and this is kind of When Things Fall Apart right the risks are not properly assessed and the infrastructure isn’t there so we have to be more proactive we have to have a learning mindset I
Think both of you touched on an interesting point because on the one hand as you said like people still run on an old system they run on Windows 98 and they pay good money to still run on Windows 9 right a lot of hospitals still paying a
Lot of money to Microsoft to keep up the security for example um at the same time as you said the obsolescence of those systems is faster and faster and faster so how do we install that trust in people that the move to cloud is actually a good one and that they don’t
Have to reinvent the wheel in a year or two is this me sorry yes go for it I I I will be happy to P up yes go for it okay um so like I said we need we need to bring it in early we need to practice we
Need to fish around um they would say oh here comes Monica trying to break our systems I would just best time to break the system is before you buy it right just get your hands in there click around see what you can do one time there was a software that let users
Backspace now if you look at the protocol or if you look at the manual it says enter you know value 66 and click here I did not click out I stayed in there I was like oh I put in 66 what if
I made a mistake and I put in oh I at 67 and I backspac and that wasn’t captured anywhere right so if we’re if we’re proactive and we’re spending our time and getting to know the system intimately down to its pieces we will not we will not be scared when it’s time
To go live we will know every single thing about it we know how to control it we have the controls in place and your organization also if you have good data governance the people within your organization they understand why we don’t share passwords why do we check the auto trails what are
We checking the auto trails for I mean we’re not just seeing if there’s an audit Trail we have to look in and read and and see what’s going on if there’s anything suspicious or if it’s normal um and so you have to empower the people within your organization to understand
Why they’re doing the things they’re doing and it should come with practice it should if you have experience you know along the way you make mistakes you learn and that gets saved in your knowledge bank and you apply that to more and more systems As you move
Forward Reena you wanted to follow up on that yes I I lost a little bit now the thread of thought because Monica’s answer was so good but actually I think think what I want to hang on from what you said is that quality requires actually H knowledge requires time
Regarding requires curiosity and really trying to understand what you are doing and I think what I see very often is that people er er hide behind processes procedures forms and templates and checklists so instead of of trying to actually a really understand the system that they need to work with and what it
Means Etc they are hanging on to some kind of outdated checklist and they don’t always get the right support from their organization in order to update the checklist um so there is meaning there’s really a knowledge Gap and I think I’m I’m hinting to you Marcus because you
Are a gum five expert and now a gum five version two expert and what I always remember you saying is that so many people wave gum five knowledge or gum five buzzwords without actually knowing what gum five means and so so is this still the case because
The last time I heard you rant about it was was a while ago and if this is the case how can we close this particular Gap this is still the case um so so at least we have the still the same um compliance level maybe and I think
That’s also what what Monica was addressing in in her answer um so I I can I I would be able to talk about hours uh here on IB Gam fil five and there’s a wonderful good practice guide which is called enabling Innovation um it’s simply brilliant what what is in
There like they say using uh tools instead of documents or forms or this kind of tick boox mentality and um acceptance instead of approvals exactly what what what we are talking about um as usual if there are s in place since two or three years it will take some
Time that the um wi or industry is starting to apply that that needs some time that it’s that that it’s read and understood and then we think on how we will do that uh within our regulated environment if we would say yes we have a new regulation or we have a new best
Practice standard even then people are still doing the same things like they have done before giving their own rational yes because it’s how we did it all the time um the classical example from this industry is if we talk about process validation we will execute three
Badges so um this is now since four or six years um this is uh revised and and um there there are much more better ways in doing that and now it’s 202 for you still hear that so you must think about how can it’s a little bit I call it
Quality Marketing in the best meaning quality marketing so what we have learned and then I will give over to Monica again from the from the several data Integrity projects uh that we have done and GAP assessments 20 years ago we did the same with part 11 we had the
Assessments we did know the gaps and then the project was ended so we never had the the the the the level two and three of such projects uh projects and regarding data in in Integrity or if you look into wh uh regulations they underline always the management uh governance the management quality
Culture um Europe is writing the ultimate responsibility regarding data Integrity is with Senior Management so coo and so on and then you see yes we can have the best standards some companies have the best tech technology you will find this freaky cool guys uh working already with Confluence the rest
Of the world in this company is working still with world and Excel and so on um and I think this was maybe also the reason why we put it together in this way industry 4.0 needs organization 4.0 Z organization 4.0 is a value based leadership um of values what what what
Do we want to do Reena you know it yourself people are we want to have an A agile software development life cycle and then you look on the AR chart and the AR chart is the same way in the 19080s so agile management and agile what does that mean for management you give
Responsibility to to other people and many people can’t do that so they they love to keep it like it is then I know it there’s there’s there’s nothing strange uh nothing could um surprise me this is what I know and then I can talk about what is written in gam five for
Hours but then the next thing is how to implement it into an organization and with the right tools and some comp start with the tools and then they are frustrated because it does not work because like we we had an email yesterday Reena me configuration is
Important if if you go there the wrong way it’s ending up in a and then you will find always someone I told you I think that’s also English I told you this this will not work now uh you have seen that it’s not working and then you
Have exactly the reverse effect that you wanted to have you want to do the change and the people declining the change are now on The Winning Side and this happens all the time and I think it must work on management level quality culture on this things providing the right tools and the
Standards who can be a a blueprint or something like that that that can guide through that um but um that there must be two or three different things happening that that it is a success if you only have one the greatest tool without the procedures without without management attention and
Management commitment it will not work so what popped into my head while you were talking right now especially if you’re looking in the in the medical industry farma industry we do have an organization let’s take the US let’s take the FDA that we have to present our product our uh documentation and they
Will then sign off on this and let’s say government agencies aren’t necessarily known for being the first in line for any kind of innovation at the same time we as in the Private Industry are trying to bring people to work more efficient more cost efficient um more toward geared towards
How their team is working agile is one example of that so what are your tips to bridging that Gap because in the end it all comes down to we develop a product and we have to present it to an agency who then has to sign off on this um so how do you
Bridge that Gap Vina maybe I think first of all you you hit you hit the problem on the na because very often this is the excuse for not innovating in terms of your quality system ER because for the very often the quality and the regulatory team itself they will block Innovation because they
Will want to play it safe against the agencies so in all organizations when I where I have seen Innovation on that level happen it was because the qira team in an organization was brave enough to take risks that’s my my take on that and and for them to take risk they needed what
Marcus was mentioning the endorsement of the ER Senior Management the expectation of Senior Management to to take those type of a risks and the second thing that they really needed is what Monica mentioned is to know exactly what is needed and a lot of quality assurance and Regulatory Assurance
Teams rely on habits rather than actual knowledge of the of the regulatory requirement and being very up to date with the state ofthe art Etc that’s that’s my take on that but but Monica and Marcus Monica maybe you you want to to add to that
ER what’s your aspect from that I yeah I think that’s perfect I’d like to add that the risks that they were that they’re taking they should be fully understood and fully mitigated and they should have the confidence of their teams like are their teams confident do they understand or are they feeling a
Little worried maybe the timelines aren’t right and I also suggest just start simple unless you’re a startup recommend having very good digital hygiene from the beginning so that can it’s a Snowball Effect if you have good digital hygiene it’ll grow with you if you start off small and everything is
You know ad hoc and quick and multiple hats and things start to get out of control really quickly so it depends on the confidence of your teams and how they’re presenting that to you um and if they’re not confident then we we should figure out why do we not have the
Knowledge on the team do we not understand our systems um and then you know start from there and then build up I I think you know having the support of Senior Management is crucial but also having the support there after you make the decision to actually carry this through successfully to execution is
Also crucial I don’t know what do you think Marcus uh yes uh that’s uh perfectly right um and I love the question of saskia because exactly a a business is operated well and finally we want to have from any agency the US FDA or in
Europe um we want to have a GMP license or um we go through a gcp inspection or whatever or in the medical device industry we have an mdsap audit and so on okay and uh but but the inspections are inspections they are not assessments um and I know some
Inspectors and for example if if I look on things that we have done not too not not not a long time ago um for example audit Trail reviews and I I met one German inspector and I was saying he was in inspection situation and they presented them 4,000 pages of re review
Protocols filled out in handwriting and so on um and he was saying you know within an inspection the compliance is checked so if you comply with the regulations it does not say um that you um have hit the nail on the head uh you can spend thousand of pages you can get 40
People in reviewing data and so on and the inspector will not judge if you have done it efficient or right it it could be that you have invested $1 million euros and whatever and accidentially you have done this the right thing because you have done so much and uh I know it
From an inspector saying I’m wondering how much money the people spend for some of these things and even they do not generate any added value for the company itself they just want to satisfy or they think they they there is an expectation level and they want to satisfy the
Inspector I have that sometimes that people or customers are saying hey we we we we we we we we were successfully going through the US FDA inspection and we did that this and that and I said okay but how much money did we spend for things that are totally useless but an
Inspector will not tell it to you because it’s not his job if he finds a non-conformance or non compliance he will write an observation form 483 and so on for sure this will happen but I think beside of inspections I think one of the key areas should be also to do
Assessments internal audits this is something that that we are still not good enough but again Sasa I fully agree with you that people just see okay in two years we have the inspection again we do this and that and that we sometimes we might question ourselves if
You if we put the right efforts on the right thing especially I sometimes I hear we do it on a risk-based approach but I see no it’s um o overthe toop approach yes it is successfully at the end but what have we uh paid for it a
Lot of uh money for it maybe exactly a lot of times organizations measure the raqa based on the number of conformities at the end of the inspection but not regarding the cost of how it how much did it cost to arrive to this number so yeah and and maybe just one
Sentence and even like you were say Reena and Monica that people say we do it like we know it and um also saying we don’t know the inspector or investigator who is coming and but but but for any inspection you do a kind of a profiling who will visit
Me you do the same for audits what what are their Hobbies or the key interests and so on and you can also know um is the person coming a digital native can we show to a person EV validation to to to run the inspection on a projector on
A screen to say look here are the Sprints and here’s release management or does he think about anything else if he or she is hearing the word Sprint is it really understood as a a software iteration just as one example you know um and um and this is what I think is
Also very important whatever solution we are working on uh also to provide a hybrid solution Reena we also have done that if somebody’s saying but I still want to have the pay okay we push one button 600 Pages Word document now the question is do we want to print it or
Only PDF it depends on how much we like the trees but um this is uh something um always to to be flexible in two or three solutions that you that that you catch everybody yeah we can still do it on paper we do it in here basically if you
Show there’s no difference and if the inspector is coming and he’s a traditional thinking person we will show the paper no problem I have one question for Monica because what we’ve talking or what we’ve been talking about now is a lot like how do we work we as people how do we
Interact with each other but in the end what we are producing here is still a lot of data one form or another and for me person personally one of the biggest um advantages of moving to digital systems and in the end also moving to Cloud systems is the availability of in
The best case one single point of truth right so how do we make sure that we’re not just like typical examples scanning all the documents that we have and then we have V one V2 V3 and nobody knows v3.1 maybe even and nobody knows what is the actual doc that we’re working how
Much is kind of like data hygiene important when we start the shift how do we make sure that actually works well right at the beginning you don’t want to do anything until you understand are in and are in agreement with the whole team what the process is going to look like
Um it’s things like I said can get out of hand if your system is not adequately controlled we all know we do things differently I do things differently than the next person sitting next to me if there are so many things allowed within the system
You can guarantee the way that I do you know if I generate this document or I upload this document or whatever the metadata would probably be different than someone else who is sitting next to me so we have to control the configuration we have to understand the configuration and there’s also a
Knowledge Management behind setting up these systems behind you know why is this turned on and why is this turned off and when this turns on this has to be off and that’s like they go together that needs to be documented I always you know put an extra column in and while
We’re doing it with the the vendor the consultant or whoever I’m writing everything down if this turns on then this must turn off and you know that way it’s not lost there’s so many there’s so many pieces of metadata about systems and how the systems are set up that just
Get lost with people if they leave the team if they leave the company that needs to be managed you do not want to be in a situation where the team member who set everything up for you did it in such a way that was you know a workaround for the infrastructure
Because the infrastructure wasn’t there and then that person is now gone and now there’s so many problems and you have to spend so much time and so many resources and so many fires to put out because now you have to reand and you might not even be understanding it correctly you know
Your interpretation of what’s going on might not even be accurate accurate um that’s just my take on things good digital hygiene in the beginning starts simple I don’t recommend you know these SAS um systems and everything like that they offer you the world they’re like we
Can do anything you can think of right we don’t want to do that we want to start simple we want to get Mastery on a simple system and then slowly and you know obviously in the sandbox or in the development or whatever start to understand what happens if you change
This do we like it get the users in there do they like it is this something that we could put into the workflow or is it going to cause too much you know too much variance and the data is going to get out of control we don’t know how
To review that and and and you know there’s too many things that can happen so definitely start simple get it into control under control and documents everything of why you’re doing what you’re doing what do you think Reena I think it’s exactly that and it’s so nice
That you express it in that way that is actually just a good Common Sense practice even if you are not in pharmaceutical so with a with a jir for example it’s exactly correct that you can make jira dance and whistle yes the the sky is the limit but if you don’t control the
Configuration and you don’t know what you have put there the organization quickly goes into spiral of people not knowing exactly how the system behave why the process behaves in that way or the other although it looked very logical when it was first defined so keep it simple and keep the the
Configuration basic and not try at the first iteration automate everything automation is now a big word and everybody wants everything to be automatic we don’t want manual work we want the system to know exactly when we need to move something Etc be careful of those of those type of aspiration
Just when you start get going yes any automation needs to have a very good reason to put in place we have a question in the chat that picks that up and actually hands it over to mic is because uh the person in the chat is writing being able to do
Anything is not found in the CFR I or G def find a need address the need everything else is just bells and whistles from yog Gad s position what’s your take on that uh yes uh okay um CFR I or G so the first two are regulations and and by law
And gamp is a a best practice standard um being able to do anything um it’s always especially for regulations it’s an an an own interpretation how to do it um as an example uh code of federal reg relations or GMP is saying you should have control your
Documents um yes uh basically you can do it on paper microfilm um electronically you can even throw it into stone um no nobody is defining that um and um I use the things for my own benefits um and and that’s the interpretation uh that I’m doing um in
In the regulations for example uh it is written audit Trail should be regularly reviewed so you ask the first consultant and they say is um yeah you can do it on on a yearly basis the next one want to be better and say we do it on monthly
Basis the next one is saying on a weekly daily hourly basis yeah so um none of them is fully correct and but nobody is also wrong so um yes um managing regulations a lot of companies have the biggest problems with that to Define their own compliance map to say to do
Their interpretation of regulations and that’s the other risk um that people listen to um what was said in an event what is written down in a LinkedIn uh thing um and and then they believe for example jira is the tool for everything um plug and play uh standard
Configuration and it works um that that’s not happening with compliance issues with compliance topics that’s not happening with the tools uh that’s not happening in changing the organization with I call it a soft power strategy to say yeah we we must get there yeah um a nice uh comment or nice question um
Even on on the other side if if I meet people and say okay how do you do the validation they say we do it according gam five I say okay gam five itself has 400 Pages references to 100 other guidelines ISO stand most of them some of them with 20,000
Pages and game five has then also 17 good practice guides all again with two 300 pages so saying I do it according gamp it’s like you would say I’m doing that Under the Blue Heaven that that’s right but it’s very generic right and uh this exactly what happens in an
Inspection um GMP compliance or any any kind of compliance the inspector sometimes you can put yourself into the other role if you think about that and say what would I think as an inspector if I’m doing this and that interpretation and like for cloud or or
Or or I had one a situation saying in the regulation it’s written you should do on a regular basis you should do backups so I was standing in front of um um an automation system a PLC system and I was told according theop and it was
Told to me because it’s written in theop it must be correct that was the the message we do a backup every six years so the regulary requirement is met because you do it on a regular basis I was just saying listen Murphy’s Law will teach us that the hard dis will break
After 5 years and 364 days and then you will lose all your production data from this and this really happened to me and then I was asked if I want to join because they needed to visit the agency to explain that they lost the data for six years and I said uh
I I’m not willing to join this for two hours that’s for the consultancy rate it’s it’s it it’s not worth to do it and they would say uh but you know um these are the things that really happening indeed yeah and um then you have can have the best regulations or
Not or follow them it’s always about a vice interpretation of the regulations can I add something I think be in that case risk was not fully understood or even thought about right yes the term risk management I think scares a lot of people and a lot of
People just step away and say that’s probably above my pay grade I don’t think that’s true risk management is simply what can go wrong and How likely is it right you don’t need to be you know a genius or a VP to understand in what you do every day what are the risks
I think everyone should be everyone should be involved I think risk management should be done within your team even hey this is our line what do you guys think could go wrong you know what what do you foresee happening you’re on the floor every single day you operate these machineries you know
However many hours a day in your perspective what can go wrong that’s not something that another person can do because they’re not on the line every day right so when you are evaluating risks you have to do it according to what you contribute to the company it’s
Not it’s not someone else’s job it’s your job and and I like it so much because it’s really really speaking to Agile principles yes agile is a lot about team empowerment and I think that a lot of the companies who really try to be agile Etc don’t get that part of of agile
Culture if you want to Foster an agile C culture in your organization you need to make empower the team to make their to make good decisions basically yeah so to sum up what you just said what I heard was first from Marcus stop looking for Best Practices start looking for the good practices
That actually bring you benefit that is not just a copy of whatever you find on the internet that might not necessarily apply to your use case specifically think for yourself in a way Monica said the thinking for yourself is not just tied to the pay grade or your
Position on the corporate letter but it’s actually everybody’s job and what reeno was than adding is and that’s basically the foundation of how agility works if you want to have a good agile team everybody’s empowered and everybody themselves feels the accountability to do exactly that so how do we bring that now into
Practice what’s the first step that we can take and actually get that the agile ship off the ground so to speak okay I I would like to answer that um like I was saying um that um we talk about value based management or or leadership even leadership like you were uh doing this
This this conclusion um to empower the people right um so the first thing is that you should really analyze in which kind of organization you are and where where is your starting level I know there’s some methodology it’s called Nine levels uh of different value stages and this is
This is very interesting yes uh that you say okay first of all and we know a lot of that companies uh you start your own business you you you are really like you can it was taken how how a human being is developing so you are a baby and and
And you need full support of of of your mother you you can only sleep drink and eat and and the other thing and um then you get a teenager and and companies are developing AIT similar and there are maybe some wild times and so on and it
Takes a level to to get on an adult level then it might be that you have an um a kind of egoism in in in in in your doing even in in companies and um then it’s splitting also a little bit maybe you have this kind of uh little
Departments one department is using this tool the other department that tool and it’s an internal Challenge and so on and after a while you get a vice Guru of of everything and companies are a little bit same the first thing is I’m looking on which kind of level is this company
And where they want to be in this philosophy it’s very interesting you cannot come from level one directly to level four you must go each step you can just Google it level four it’s showing stairs going in in a cycle um up and that’s super interesting and I think
It’s first of all if they tell me or that’s my experience after a while uh we want to have EV validation you is is there the capability and people do change we will also change to say we need other whatever Electrical Power Systems and so on not when we can do it
And if we would still we are driving the car Until It Breaks and then we will do the change if we really have the problems in front of us and the motivation for the people should be before it comes to that we must change otherwise the change will be much harder
Um it will cost a lot of more money um so before I talk about what is in gam five on on Senior Management level they do not care in the first moment what is written on page 348 of the gam standard maybe it’s great and it’s you know but
The starting point is is where do I pick up the people are there on this still on a baby level that would be fantastic it could also be that they say in our organization we stay on that for the next 100 years then it’s it’s a decision
They can say we do Agile we still do waterfall model um you don’t need to to to to to run whatever comes in fashion and you you do take that all with you you you can’t you simply can’t but I think that’s the starting point to be fair to
The organization and then to say I had that really from level one to level four directly we we we we we we have some Excel sheets directly to digitalization e e bch records management including automated pqr and say stop um it then I take sometimes also like like my
Children you learn training swimming and so on and and you do not start in a Formula One car it’s too much okay good point good point you need to meet the organization where they are and then take them to the next level right Monica given what we have heard for the last 45
Minutes there was a lot of ranting and a lot of okay can we please stop talking about this and putting this forward as a reason um so there’s obviously still a lot of work to do but what makes you actually positive or or forward looking into the future because it already goes
Very well there’s already uh a good piece of thought or maybe an standard that has improved or that has implemented itself what makes you positive about the shift I think I think we’re headed in a good direction and I’m excited because we’re all getting on here to
Talk to each other right we’re all sharing our ideas and I think we can take that into our organizations and into our teams there’s a lot of hypotheticals oh we should do this we should do this infrastructure this and data review that this doesn’t mean anything without the relationships that
You build within your team and within your company and I think emotional intelligence is so important because nothing will get done if you don’t have that relationship if you’re everyone just working in silos and I think that’s the big one of the big problems is like
Oh a ton of it experts here and a ton of OT experts here and QC experts there but in order order to make things flow and data Integrity obviously not within a department or not within a system it’s within the entire organization you’re going to do your data mapping in order
For everything to flow successfully we got to like get ourselves out there and have organic relationships be curious you have to be very curious curious about the person what do they what do they do what do they how do they like to go about their day in the lab or how do
They like to go about their day in in the engineering World down on the production floor just we have to be curious and have to build those relationships and then the knowledge transfer will just come naturally oh that’s what you’re doing with the PLC oh that’s interesting what we do in here is
You know this and that and so that’s I think what’s exciting is that this is all built on relationships on culture and if I could just add two cents on the culture because I think that’s such a big word these days and I don’t think I
Have all of the answers but as a person who kind of grew up between two cultures my parents are from somewhere and I was born another country and the culture I was surrounded with I didn’t learn a culture because I read a book or because someone gave me an sop or there’s a
Poster on the wall culture is behavior right what are people be what are they doing and then you look and then you assimilate oh in order for me to fit in I have to act like they act and so when you’re assessing the culture of your organization and you want to make sure
It matches that sop or that motto or whatever the behaviors that you see around you is that reflective or does Senior Management need to re-calibrate and drive it in whichever direction it needs to go and when those behaviors do match the SOP that’s the culture and that’s the relationships and that’s when
Everyone can add to the continuous Improvement because there’s no one area that’s going to improve the entire company it’s every area that needs to improve and they need to do it together with that thin thread that you know runs throughout the organization what do you guys think
That was Liquid go gold what you were saying very simple well just end on a high note and just say thanks no it it it is this kind of flexibility and I know what was also Reena saying people believe in a procedure and in their Sops and their forms um and it’s
So important what is happening around of that and and even sometimes to be fair enough and to say I I need to recalibrate myself also is it still okay what I’m doing this kind of positive feedback and sometimes um I have the feeling that we
Live in a fast uh U Society with a lot of information we swipe to the next and so on and um it is required to do it in a team approach and that people understand uh that this is exactly the point if you meet a consultant Monica and like you
Were saying I know everything uh if if you find someone uh who who is saying that it’s simply not true and not everybody has skills to do everything um I started with that topic with EV validation with Reena seven eight years ago or or nine and and and I did
Something in confidence at a certain point I must say I’m still a beginner I need the expert for doing that um maybe I will talk sometimes to a management um I reach the person or I don’t then I need someone else maybe with with coming from another area
Talking a different dialect or something like this even little things um will trigger a positive change um I like that culture uh uh story that you told and it’s exactly and it’s exactly the same for all of us and um and that was very important and then again you can say
Great tools it’s all little because I’m from ravensburg it’s all little puzzle parts we must bring them together mon ravensburg is very uh famous for the puzzle games here okay this has been a lot of information Monica Marcus you already shared what’s your first step Reena let me ask you for
You before we wrap it up um what did you take away from this what’s your uh take on all this and how can you as more of like from the software side contribute to what we just shared to the whole culture discussion ER I think it’s so important
In a the projects that I do the most determined the most important factor that will determine if a project succeeds or fail is the culture we manage to build within our team and H nothing beats a team that has a good spirit and can collaborate nicely of course
I’m working with atlassian and atlassian made it their a whole logo and kredo and what have you to to to promote teamwork in the whole Enterprise area not not specifically in Pharma but in in Pharma where I typically work this is so so true so I I salute Monica and Marcus
And I think we have a comment that uh sums that up perfectly as I said culture eat strategy for breakfast that is a that is a good summary and if if you work on your culture the rest will follow if you work on for Thanks Max for for giving it it’s
Nice so true yes wow this has been a lot of input a lot of information a lot of great uh things that we shared a lot of great insights that you youth be shared it’s been a blast it’s been a blessing uh thank you very much the three of you for
Sharing all of your wisdom with me and us here um for today this webinar will end now um but we already have a lot of them lined up to follow so um if you want to join in for other conversations that Reena and I will be having with
Other guests and other companies um follow us on LinkedIn subscribe to the YouTube channel wherever you watch us and wherever you want to follow us and then you’ll be uh invited to join us for the next grade conversation but for now let me thank you again Rea Marcus
Monica I I want just to promise everybody who put comment even if we didn’t take it now we will H I’m sure Marcus Monica and myself sasia will follow up on on the channels exactly thank you so much this is fun thank you so much thank you bye bye