LifeBee will be among the exhibitors at CPhI 2021, the largest international trade show dedicated to the pharmaceutical world, which this year will be held in Milan.
We look forward to seeing you at our stand, 2C77 in the New Exhibitor Pavilion, ICSE GOLD area.
Book your ticket here
Our CEO Teresa Minero is among the speakers of the "2nd Pharma 4.0 Smart Manufacturing Summit", dedicated to exploring how Industry 4.0 changes pharmaceutical manufacturing and how the transition to Pharma 4.0 offers new opportunities and challenges at the same time.
Join the event for her speech “4.0 in Pharma: compliance to regulations and business benefits” today at 15:50
Organised by Vonlanthen Group more infos here
Summer 2021. Numerous forest fires have been in the news in various countries, from Italy to Canada, via Turkey and Finland.
The causes?
Climate change and prolonged drought, but also human neglect and carelessness, among the main ones.
"Climate change is widespread, rapid and intensifying... From the 1960s to today, CO2 in the atmosphere has increased by 30%", confirms the alarm of the Intergovernmental Panel on Climate Change (IPCC), the UN body dedicated to the study of climate, which yesterday released the VI Report on climate change at planetary level (AR6).
It is a global phenomenon and concerns each and every one of us.
LifeBee intends to contribute concretely to the protection of biodiversity and has chosen to support Treedom once again, launching a new reforestation project: the "LifeBee for Life Forest", 200 new trees planted in Africa.
Visit our forest
LifeBee is part of the green revolution through its constant commitment to reduce CO2 emissions and its contribution to absorb them by planting trees: to date it has already contributed to plant 245 trees in Cameroon, Kenya, Tanzania and Haiti.
LifeBee for Life: make the planet green!
LifeBee offices will be closed for the Summer Break in August from Monday 9 to Friday 27.
For any urgent matters, please contact us on our mobiles.
Happy holidays from LifeBee team!
We are proud to announce that our lead Teresa Minero has been awarded among the Top 25 CEO of Europe for 2021 by The Healthcare Technology Report
"The Healthcare Technology Report is pleased to announce The Top 25 Healthcare Technology CEOs of Europe for 2021. As the coronavirus continues to impact populations in various parts of the world, a brighter light has shone on the critical importance of healthcare innovation across biotechnology, medical devices, software, and consumer products, among other areas. European healthcare technology CEOs have demonstrated impressive leadership over the past year while adapting to increased demand as well as shifting priorities in the market. Despite the myriad of challenges presented in the current environment, this year’s awardees have led their organizations ably (...)"
Read the full article here
In Life Science, product quality, efficacy and safety are the three main aspects at the base of the process to guarantee the final consumer of the product: the patient; it is not casual that those are the three main aspects evaluated by the pharmaceutical regulatory system to authorize a product to the market. They are regulated through specific laws and monitored during the whole life cycle of the product through frequent inspections and audits. According to several reports, companies invest in controlling these aspects more than a quarter of their turnover and up to 70% of their time. After all, a product of inadequate quality generates exponentially higher costs that grow as you proceed from the production stages to distribution to the final customer. According to an established rule of thumb, poor quality generates ten times higher costs than prevention, if it is identified during internal verification procedures, and even one hundred times higher if the product has already been sent to the customer, not to mention the brand reputation and legal aspects (in particular those concerning pharmaceutical regulation).
Several companies, even recently, have gone bankrupt precisely because they have not complied with GxP regulations, in particular GMP as regards the rules of good manufacturing, in which Quality falls.
At this stage, with the ongoing digital revolution and increasing consumer sensitivity to ethical and social aspects, the concept of quality is further expanding, and the Covid-19 pandemic has provided a new boost to this process. According to some analysts, in the last 10 months the biopharma industry has advanced in the digitalization process more than it did in the previous 10 years, and an unprecedented development of artificial intelligence, machine learning and IoT (Internet of things) solutions is now expected. The deployment of these new technologies offers an unprecedented and crucial opportunity to overhaul the entire workflow and make it more effective, productive and cost-efficient. In this context, the simple transfer of Quality document management systems on digital support is limiting, because it does not allow to capture the full potential of renewal and efficiency offered by new enabling technologies.
With digital transformation, Quality Assurance procedures will be strengthened, thanks to solutions that will make activities increasingly effective and automatic: algorithms to detect and classify quality events, detection sensors, data processing and analysis systems. The role of Quality Assurance itself is changing, going beyond the objective of meeting regulatory requirements. As Marco Torciani, Partner at LifeBee, explains in this interview, the process review generated by Quality Assurance can now provide a decisive impetus to the evolution and efficiency of workflows.
What have your customers achieved in Quality Assurance through LifeBee Consulting and Design?
In over 15 years of national and international experience, we have seen a number of real benefits for our clients, starting with reducing paper, improving governance, increasing the level of collaboration between different areas, and ending with a significant increase in Data Integrity that could not be achieved with paper or the mere digital transposition of processes without a true redesign. In quantitative terms, companies are reducing Quality Record management time by more than 50%, queuing by 20% and increasing the number of identified quality events (quality records) by more than 40%, as shown by several surveys of leading digital quality players.
What approaches and methods do you use to achieve these results?
Our goal is to build digital systems for document management and quality management through a holistic approach to design, driven by deep expertise and knowledge of processes and regulations in multiple operational areas. Our goal is to capture the essence of a procedure, an operational instruction contained in a paper document and transform it into a new digitalized process that is integrated within business systems. It is an all-round vision, which rises from the analysis of the detail to embrace a comprehensive review of the organization and its quality and document management processes. It is a unique approach, possible only thanks to LifeBee's great experience in projects carried out in partnership with the most important local and international digital solutions companies for quality, different in structure, size and specificity.
Can you give us some examples of successful projects?
We recently accompanied a strategic client, an Italian multinational pharma company that, following the acquisition of a portfolio of products and a U.S. production site from a large global pharma company, decided to take the opportunity to implement a corporate quality assurance process management system. It was a challenge made particularly complex by the fact that it required the implementation of a digital technology, particularly new and innovative, having to comply with complex regulatory requirements at local and international level in a very tight timeframe and with the primary objective of achieving a right first result, as there was no margin for error for business reasons.
We organized a project team – in partnership with the client and the digital solution vendor – that analysed the situation in detail and drew up a detailed plan of all the activities to be carried out. Thanks to this careful planning, we were able to complete the task on time and achieve significant cost savings for the client. In order to meet the deadline, we had to complete the project in about 5 months (normally a project of this magnitude requires at least twice that amount of time) but, despite this, the client achieved the additional goal of saving more than a third of the budget he had reserved for this project.
What are the critical issues you encounter and how do you address them?
I would say that there are three main criticalities. The first concerns the mindset: there is a certain reluctance on regulated issues to get people to really brainstorm when redesigning processes. There is a certain propensity to reproduce what you do with paper on digital. Our job is to change the model to take advantage of the innovation that technology brings. We approach this with patience and experience by guiding the client to the industry's best practices that guide us in analysing client requirements.
Then, there is the Change Management factor: the introduction of a different way of working, at all levels, in a complex and often multinational organization is one of the most critical and difficult aspects to manage. We deal with it by preparing the project team from the very first moments of the project, first of all, and by providing guidelines to establish the foundations of change throughout the organization. We do this through communication and engagement, to make everyone feel part of this change, in a positive way. In addition to this, clear and explicit internal management sponsorship serves the function of facilitating change.
Finally, there is an element linked to the expectations on the project (Right First and Continuous Improvement): when it comes to redefining the processes that impact the organization there is always the desire to be able to intercept all possible exceptions at the table and define everything at the highest level of detail to build the perfect process, based on the organizational complexity of the client. This is the common goal, but approaching it with the awareness that not everything will be perfect at the first round is fundamental in order to arrive at a solution in a reasonable timeframe, even if not perfect, but which immediately brings value to the organization. We approach it by involving the client in implementing a process of continuous improvement following the use of the system to ensure the continuous adherence of the digital solution to the evolving organizational context.
Can you describe the spectrum of your consulting services?
We provide process optimization analysis, design, configuration, integration, testing, compliance support and lifecycle management of applications. In particular, we optimize physical movement and waiting times, ensure a secure approval cycle by enabling remote work, provide ad-hoc tools and analytics for continuous process measurement and optimization to ensure data integrity. We identify digital solutions suitable to each customer that allow a better and safer management of information – which are controlled and always available, even in case of inspection by a regulatory body or a sponsor/customer – an easier archiving and cataloguing of documents along the entire lifecycle, and integration with other business systems (such as ERP, LIMS, MES/EBRS) to improve traceability and data integrity – which in pharmaceuticals is a must –, as well as mitigate the impacts of human error in the information flow between the various functions involved in ensuring product quality.
Why do your customers choose LifeBee to evolve the level of quality assurance?
LifeBee has twenty years of experience in the Life Science sector, with over 600 projects behind it, and can address any issue with a deep knowledge of the entire production process and its quality, of the relationships between the various areas and business functions, and of the impacts – positive and negative – that any change can have on the entire process. In the field of Quality Assurance – particularly in the pharmaceutical industry – this competence is a fundamental added value because it is a transversal function that necessarily crosses all areas subjected to the pharmaceutical regulatory system to ensure compliance with requirements.
Thanks to the Best Practices defined by our multiannual experience and the experience of our partners – ranging from market leaders to more agile and adaptable realities – we can analyse the specific business context with the customer, in order to identify tailored solutions that respect the specific needs and also any criticalities of the company and enhance its distinctive components.
Today Teresa Minero took part as Speaker, in the guise of both ISPE and LifeBee, at the XIV Seminar "How Robotics, AI and Big Data are driving the digital transformation in the pharmaceutical industry", organized by United Nations Industrial Development Organization (UNIDO), with the participation of Alejandro Rivera, Shahid Hasan, Christhoph Herwig e Toni Manzano.
“The pharmaceutical industry is steadily heading towards the Fourth Industrial Revolution. Advancements in AI and BigData are accelerating the development process of medicines and vaccines by improving the accuracy of patient selection for clinical trials and providing a better insight into patient behaviour to increase drug delivery and effectiveness.
The COVID-19 pandemic has reconfirmed the need for building and strengthening local capacities to produce essential medical products, including vaccines, antibiotics and personal protective equipment.
This session examined the potential of 4IR technologies to support production of pharmaceuticals in the context of current global trends."
It was a pleasure and an honor for LifeBee to attend this session and to share knowledge!
LifeBee and the Earth Day 2021
LifeBee in collaboration with Treedom
Since 2019 LifeBee has supported the planting of 45 trees in Cameroon, Haiti, Kenya and Tanzania, helping to absorb 7,920 kg of CO₂
Our trees are gifted to those who participate as a speaker at our events.
LifeBee for Life: make the planet green.
We believe in it!
4.0 in Life Science is expressed as an authentic movement comprised of innovation of processes and transformation thanks to digital systems.
LifeBee has been championing digital transformation in the Life Sciences for years in order to reach operational excellence and proactive compliance.
Teresa Minero, part of the Global Steering Committee of ISPE Pharma 4.0™ and the subject’s point of reference for the International Board of Directors of ISPE, is the author of two articles in this special edition of the renowned Pharmaceutical Engineering magazine of ISPE:
1.2020 ISPE Pharma 4.0™ Virtual Conference Highlights
Written with Thomas Zimmer, Christian Wölbeling and Chloe Lang.
2."How to Pitch and Shape a Pharma 4.0™ Project" Workshop
Hope you enjoy reading!
The transformation of procedures from paper to knowledge: this was the theme of the webinar organised by LifeBee last March 3, with the patronage of Assolombarda and the original and innovative contribution of Heike Roeder, authoritative voice at international level as executive expert in Digital Solutions for Quality Assurance in Pharma.
A subject that is very important for the future, also in light of the current developments in Pharma.
The webinar, "Digital and 4.0 in Life Science: the transformation of procedures from paper to knowledge", targeted the SOP (Standard Operation Procedure) totem in its traditionally documental and paper-based form, and shows the way to move from document to data and information, in the spirit of genuine digital transformation of processes and mindsets in Life Science.
A successful strategy, judging by the numbers of the webinar, which saw more than 200 participants from 90 companies, mainly in pharmaceutical, API and Medical Device sectors, but also nutraceutical, homeopathic, packaging subcontractors, production machinery and CROs. And 4 participants from the Medicines Agency.
Felice Lopane for Assolombarda gave a brief and significant greeting, reminding us of the ambitious and realistic Life Sciences Hub project: to aim for the development of digital solutions in industry and healthcare, both concretely on the ground and in close connection with the global movement, not least through the chairmanship of the Health & Life Science task force in 2021 of the B20, the G20's business counterpart.
Teresa Minero, CEO and Founder of LifeBee, introduced the 4.0 scenario that acts as humus in the digital transformation of Life Science, and is the coherent framework from document management to knowledge management in the case of SOPs.
In the same way, we should not forget why we should adopt the 4.0 approach in its entirety: to have the right information at the right time and in the right place; to support decisions, large and small, always with a perspective of prediction and guidance; to pursue and improve compliance and, ultimately, to provide quality, effective and safe medicines, at the right price, to the patient.
For this reason, Teresa Minero's LifeBee has been advising Life Science organisations to devise and implement their own roadmap for 4.0, focusing on their areas and goals. A roadmap based on the continuous improvement of processes and which, using the best available methodologies, identifies and defines the projects to be implemented, monitoring their evolution, their path, their budget and their benefits.
Regarding the 4.0 evolution of Quality Assurance processes, recent and settled experience shows and demonstrates the value of the applications of new technologies in predictive analysis for quality management, in the definition and use of KPIs (Key Performance Indicators) for the continuous assessment of processes, in on-demand analysis during inspections and audits, in virtual training for sterile areas, in the categorisation and investigation of Quality Records with the aid of artificial intelligence. Just to give a few examples.
The right framework in which to evaluate the new perspective of digital SOPs: information and knowledge, no longer documents, especially not on paper.
Heike Roeder introduced us to the concept, aims, criteria and practice of digital SOP. A simple idea, revolutionary in its own way, with great cultural value and inviting prospects: moving from documents to information. From the centrality of paper to a focus on process. All processes. A simple idea, which is not trivial without a paradigm shift in mentality and approach. In culture, supported by technology.
The SOP of the future is digital, easy to use, accurate and intuitively easy to understand. It is accessible from anywhere and provides the right information at the right time and in the right place in an attractive personalised format, such as text, voice or image and video.
It is not a distant future, nor is it some kind of luxury: let's see it.
As it should be, let's start with the "why", which in turn is quickly stated.
The reason is well represented by the combination of the evolution of Life Science and the situation of SOPs. Life Science is going through a period of turbulent evolution, with economic pressures, urgent demand for new drugs and vaccines, increasing structural complexity, supply chain transformation, reorganisation, generation change and, at the same time, it has embarked on the road to digitalisation and the increasing adoption of new technologies in many directions.
On the other hand, documentation is increasingly at risk of appearing as a bureaucratic frill rather than an effective support to operations, and with digitisation processes too often resembling 'paper on the glass' (which refers to mere digitisation), rather than a real attempt to add digital value.
So, let's look at the "what". That refers to what it means to move from documents to data or, if you prefer, to digitalise SOPs in terms of holistic transformation.
It means forgetting about documents, and focusing instead on processes: what information is needed at what time?
No less, no more. This is why processes must be designed, their logical and physical steps must be implemented, and each step must be provided with the necessary information in the most appropriate manner: process principles for the supervisor, work instructions for the analyst, technical diagrams for the maintainer (here the most user-friendly interface technologies may finally be useful). In other words, it is necessary to design a process architecture, to define a flow of information that corresponds to it, and to identify appropriate digital solutions: that manage flows and processes, and information as objects, also in integration with other digital systems, such as MES and LIMS.
It is an important transformation, and we have to observe what values are at stake, also by measuring them: performance, organisation, compliance, flexibility. Values such as culture itself, which is both cause and effect of this transformation.
And it is important "how" to implement the transformation, perhaps the most difficult part.
It is a structured path, defining the architecture and structure of the approach, going through standardisation, integrated process coverage, organisation of information modules. In successive steps from the design of the intervention, to the application in well-defined areas, to incremental roll-outs until the whole organisation is covered.
And should we talk about the company's attitude, and the implementation team itself? Yes, we should. But time is short: we'll talk more about this in future webinars.
A quote from Heike Roeder deserves the final space: “Excellent webinar with an impressive large number of experts in the audience. Inspiring to see that digitalization is has reached the industry, the use of innovative digital technologies is progressing. Digitalization offers a new dimension of mastering information in the meaning of “the right information at the right time at the right place”. Especially our SOP Management will benefit from the new digital capabilities to increase compliance, effectiveness and efficiency, and user-friendliness. It was a pleasure for me to share my perspective about the “SOP of the future” and path of transformation towards a data-driven process-oriented information management system.”
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