2020 has introduced us to extremely challenging situations, to everyone in this planet. We’ve all been impacted in a way or another, some more severely, and we all remain profoundly sad. Yet, the situation was calling for action and we focused on alleviating the suffering when and where possible.

A lot of things happened, yet it has also been the opportunity to again adapt and look for moving forward with strong desire to reach a new “normal”.

This post is a positive look to what we´ve been able to achieve while overcoming emotional and financially the impact of the pandemic situation.

NL42 was created in 2012 with the intention to bring to our customers the decennial experience of its founders and help improving how the quality processes are implemented to achieve the goal of “paperless” activities. On this past 8 years, we´ve consolidated a reputation of wise experts with professional “savoir-faire” and care to details. We´ve developed a portfolio of independent consulting services and invest lot of energy and enthusiasm in the Academy

Paperless Projects Execution

We have been very fortunate to collaborate in various initiatives we have developed together with our customers  and partners.

The number of customers trusting our experience and knowledge has largely increased in the last years. We are pleased to know that customers have been able to start their digital transformation journey with us, they have implemented critical systems and validated them. We are pleased they have chosen us to support them during this journey.

In order to support all these initiatives, we have worked hard to streamline also our processes with the acquisition of an “end-to-end” solution to support all our activities. The automation of these tasks has allowed us to be more reliable and timelier in providing you our services.

During 2020, we have made a large investment to develop a Quality Management System and we are pleased to inform you that we have achieved the ISO9001 accreditation just few weeks ago. We believe this is an additional demonstration of our continuous commitment to deliver always better services to our customers

The NL42 Team is growing

We have always believed in building a flexible working environment to provide the best services to our customers. At the same time, it was very important to ensure that sufficient resources were available to deliver the best projects. We are working with a series of great partners and, despite the difficult circumstances, we decided to expand the NL42 team.

As some of you already know NL42 stands for “New Life for Two”, and this is how this personal initiative started.  Yet the team is growing as we decided to sacrify management incomes rather than employees and partners.

We’re glad to introduce you to:

Alida Manchado Gonzalez has joined NL42 as Junior Project Manager during this year and helped us in very strategic projects with customers. She has also taken the role of Quality Assurance Manager and led us to a successful ISO certification supported by a complete paperless Quality Management System.

Alida has a degree in Biochemistry from the University of Navarre, Spain. She also has a master’s degree in research, development and innovation in medicine. Alida is Based in Alicante, Spain.

Giulia Mussi, co-founder at Impronta Digitale, a Web agency based in Milan, is a key asset for NL42 : since 2018, she collaborates in all related digital marketing projects supporting the Paperless Lab Academy initiatives and the event management.

Bharti Khanna, founder director at Amarant LifeSciences Pvt. Ltd based in Delhi, India is our key local partner for the management and organisation of the Paperless Lab Academy^® editions in India.

The Paperless Lab Academy^® is expanding geographically and proposing more initiatives

NL42 is the organiser of the Paperless Lab Academy^®, an initiative started 8 years ago as a European congress that has grown along the editions as a platform where to find information about scientific data management, automation and digitisation of laboratory and quality processes, amongst other related topics.

A lot of companies have joined the PLA, as sponsors and also as visitors. More than 50 companies have chosen PLA as a trusted platform to promote their products. More than 1,500 people have joined the PLA initiatives: Event, Training courses and Webinar ( see Academy Webinars Program)

The PLA network is growing every day at 360 degrees, more companies that own laboratories are reaching out for information while new innovative providers are looking for being visible to our increasing PLA Community. Last but not least, this would not be possible without the golden contribution of the PLA speakers at the Event editions and webinar sessions.

The impact of the pandemic situation to the event organiser industry has been really strong and we had to run a quick and decisive risk management for our PLA2020 European edition that was planned by April 2020.

While postponing the European edition to 2021 thanks to the support of the 30 providers that were confirmed to 2020, we invested time and energy in learning quickly how to reach the same quality standards through a virtual approach.

We have just concluded our first virtual event, the first edition of the Paperless Lab Academy^® in India, which was planned by November 2020. Even if it has been a virtual event with the limitation in networking that we all know, the satisfaction survey has confirmed the relevance of its program which has been extremely welcome by the Indian industry.

We are now looking forward to 2021 edition in Hyderabad to return to live events

We are now working hard to ensure we can join you in April 2021 for the new edition of the congress.

We really wish that you too, out of this pandemic situation, have some positive news to share and have identified new opportunities at personal and profesional levels.

Thanks to our partners and customers for remaining close to us.

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Historically, pharmaceutical laboratories have used paper notebooks/control sheets to keep track of their experimental data, observations and results. The laboratory data and reports are the most important evidence and record of laboratory experiments and testing. A properly maintained raw data, calculations and reports are essential laboratory paper records for any pharmaceutical laboratory. 

Enabling electronic access to laboratory data will improve knowledge management capabilities, eliminate the waste of information and enhance efficiencies. 

A digital laboratory can sense, communicate, analyse and act on data in an optimal predesigned approach. 

Digital laboratories right at the point of analysis, provide real-time control and automation of testing procedures ensuring procedural execution, automate manual processes, collect instrument data, and perform calculations, limit checking, calibration checking, as well as inventory checking and updating. Digital laboratories also provide electronic documentation and access to test results. These additionally ensure compliance with standard operating procedures and approved methods of testing during the analysis, and protect the integrity of collected data. 

Digitalized laboratory setups give meaning to data, which enables “digital moments” where decisions are made at the intersection of analytics, business systems and connected devices. These elements are founded on the combined support of people, laboratory equipment, consolidated platforms, and consumables. 

Why going got digitalised laboratory?

As per a recent market research, the global market for digital laboratory is valued at about USD 300 million. Majority share of this market currently belongs to life sciences industry alone. 

As per a research done through pharma survey, 91.2% respondents claimed to be involved in at least the planning phase of some sort of digitalization adoption and usage (i.e. LIMS, SDMS and Work Flow management). 

There are significantly encouraging trends noted, for making shifts towards digital laboratories. Digital labs will add intelligence to existing electronic data with ‘Data Analysis’ algorithms. They will allow mobility for quick and easy access to information, on the go. They will also propagate simulation and prediction tools to reduce duplication and provide opportunities to integrate incongruent systems using a single platform/ single software, with capabilities of integrated information solutions through a single click access. 

Regulators are expecting more and more electronically enabled laboratories, with reduced manual interventions. Digital laboratories require to comply with 21 CFR Part 11 guidelines of the Food and Drug Administration (FDA) with respect to digital signatures, electronic records management, and software quality systems management – such as data storage, export, and printing. 

For companies having multiple laboratories, disparate instruments, and varied work-flows; data management to the required standards is challenging. As a result, companies are increasingly implementing various digital solutions that take full account of the specific requirements of pharmaceutical manufacturing, and support both quality assurance and continual process improvement. 

Industry perspective 

The need for digitalization in the pharmaceutical laboratories is continuously evolving. Definitions of digitalization are constantly building. Each geography has a different perspective of and understanding about digitalization. Many believe LIMS is the end of digitalization for laboratories. Many are still searching for a fully integrated solution that meets industry requirements and expectations. 

Electronic labs of today lack agility and accuracy. They have various short comings: – 

• Today, laboratory equipment feed data to systems where analytics filters it for relevancy; however, humans still interpret most of the results. 
• Automation is often built into laboratory informatics, but the systems are not dynamic or flexible. For example, if the performance of an instrument has been diminishing, the experimental deviations are typically unnoticed until the results go ‘out of trend’. 
• Historical relationship between an operator and a process is difficult to capture. Mistakes, oversights and challenges are routine even in a paperless or electronic environment, despite using laboratory systems with fail-safe capabilities. 

While these systems are electronic in nature, legacy architecture and infrastructure prohibit them from adopting true digital capabilities of the systems. 

So, laboratory managers having certain aspirations/ expectations from a digital laboratory: 

• What if the sample could itself “suggest” the method of testing most compatible to itself? 
• What if a system could predict a preventative measure based on historical data? 
• What if a rule based learning engine could suggest improvements based on an instrument’s performance? 
• What if the systems could predict availability of various instruments based on their workflow? 

Companies are still struggling to find solutions to problems and questions that arise in the process of converting paper laboratories to digital laboratories. As per the research done through pharma survey, it was found that: – 

•  41.9% firms saw integration with other laboratory systems as the most challenging area 
• 25.8% named the continued integration of applications with existing lab infrastructure as a key obstacle in the long term 
• More than three-quarters of firms questioned in the survey described interoperability as a “concern” going forward.

While for many companies, paper-based approaches are already a thing of the past, their replacements may be a range of digital systems, which increasingly require greater integration. Laboratory functions are often managed using a variety of tools. These can include Lab Execution Systems (LES) that drive laboratory procedures, and Scientific Data Management Systems (SDMS) to integrate instruments across the facility and centralize data capture. Laboratory Information Management System (LIMS) that is designed for pharmaceutical manufacturing and QA/QC laboratories, bring together every element of the laboratory. However, there is growing demand for a more unified approach to laboratory and data management. 

With LIMS, SDMS and LES software, organizations can integrate everything from laboratory instruments and equipment to enterprise systems. This unified approach should be scalable and flexible, that can be implemented in more than one site and tailored to suit different project requirements. This is exhibited & explained in the picture below. 

Key Challenges when implementing an integrated solution framework

There a few key challenges faced when implementing an integrated solution framework in pharmaceutical laboratories: 

• Integrated solutions are expensive: Cost incurred is based on the number of applications and data types including instruments, integration as well as number of licensees required 
• Varying implementation time: Implementation time varies depending on the scope of the project (number of laboratories, plants, geography, instruments, applications and so on)
• Integration with instruments: Integration depends on number of instruments needed and their compatibility with the integration solution. Each laboratory has multiple instruments, standalone applications and systems.
• Method conversion/ coding: The process is time-consuming as the method needs coding, wherein the user requirements are provided by subject matter experts to coders, who don’t understand the workflow of the methods
• Risk assessment: Multiple tools are required to assess risk, as complex integration solutions have multiple applications and systems. It is important to assure compliance and sustainability of the solution and make it risk proof.
• Validation plan: Typically, in case of integrated electronic systems, this involves hardware as well as computer system validation, including various software applications that may require a detailed approach to deal with its complexity.
• Dealing with technology: The challenge is to find technology that can host all applications in one place for e.g. from ERP system to standalone laboratory instruments and applications.
• Training the user base: An enterprise solution requires proper training & management of a large number of skilled users, and system administrators.

Value creation and opportunity 

Digital laboratories can be connected to and integrated with other laboratory informatics systems: laboratory information management systems (LIMS), analytical instrumentation, chromatography data systems (CDS), scientific data management systems (SDMS), modelling and simulation programs, chemical inventory systems and scientific databases, and business-level systems such as document management systems, systems applications products and manufacturing execution systems. The electronic lab environment provides a number of advantages to the industry. 

Digital capabilities can create value across the five most common areas where lab metrics are measured. 

• Innovation – Smart informatics systems reveal & highlight hidden data, and expose new insights that were previously impossible or unanticipated. 
• Data Quality – Digital quality assurance/quality control (QA/QC) systems improve confidence in instrument data, interfaces, calculations and methodologies leading to a reduction in errors, improving product quality, enhancing Electronic Batch Record (EBR) support, and improving compliance and regulatory adherence. Digital systems also lead to a reduction in corrective and preventative action (CAPA) activities, fewer warning letters, and less audit fails.
• Data Security – Digitalization enables labs to prevent, report, manage and respond to data breaches with the right skills, tools, and processes.
• Operational Efficiency – Digital LIMS help accelerate laboratory test milestones. With this, organizations improve productivity and turnaround time, increasing customer satisfaction.
• Costs/Profitability – Digitalized labs lead to more efficient data exchange, use of laboratory resources, reagents, consumables, laboratory supplies and asset utilization.

Implementation success factors 

Implementation of an integrated system(s) will typically involve consideration of many matters specific to integrated platforms, over current paper base fragmented laboratory systems. While developing a project plan/proposal, one should consider answering the following questions (indicative) with respect to cost, quality, ROI, project time, effort & resources required: – 

• What could be the possible cost savings by implementing an Integrated Digital solution? 
•  What would be the quality increment? 
• Which regulatory affairs the firm have to deal with? 
• What kind of efficiency increment could the company reach? 
• What is the effect of using an e-signature on current system? 
• How far it will fill the request of data security? 
• What is the cost of implementing a digital solution? 
• What kinds of resources are required for life cycle management? 
• Is it possible to interface to enterprise systems (i.e., enterprise resource planning or manufacturing execution system)? 
• Which analytical instruments can be connected to the system? 
• Which interface software package is required? 
• What will be the influence on my company’s infrastructure? 
• How big is the ROI? 

Success can be defined by how well implementation minimizes expenses while maximizing savings and improving productivity. 

To make implementation successful companies should consider three important factors: – 

• Business case: In general, the business case for an integrated digital solution, can be harder to make. Business sponsors view digital laboratory deployment as an investment intended to improve analyst and reviewer efforts, typical laboratory process efficiency, people productivity and regulatory compliance. Thus, success is measured by ROI – the measure of money saved over a specified period of time. 
• Expense control: Expenses in implementation include not just the cost of purchasing hardware and software but also configuring systems, instrument integration, training users, method coding, and maintaining systems over time (life cycle management).
• ROI: Success is measured by ROI, the measure of money saved over a specified period of time. W.r.t ROI, companies should consider various factors for e.g. project efficiency, reduction in cycle time, reduction in rework, time saved during information gathering process, productivity and efficiency increment and so on.

Conclusion and way forward 

In an effort to reduce the cost of maintaining and supporting multiple fragmented digital solutions, organizations should consolidate onto one integrated digital solution, having integration with ERP, MES, LIMS, LES, CDS, SDMS and other enterprise and laboratory software applications – across all sites and geographies. It must be open, extensible, scalable, and robust. In addition, the digital solution must be easy to use, simplify the user’s work process, and be fast. 

The roadmap to a digital laboratory does not simply end with adopting systems – it involves a cultural change -> how lab staff access, monitor and manage samples and results. They ultimately need to reskill and learn how to gather, record, view, retrieve and interpret data for true digital success in the lab. 

Author: VIPUL K. YAMDAGNI
Independent GMP Consultant and Adviser – This blog has been written with inputs from secondary sources . 

Vipul Krishan Yamdagni is a seasoned Quality Assurance professional with a strong analytical frame of mind and a result-oriented approach.

He has spent over 34 years in the industry with major Indian pharma organizations like, Shriram Institute for Industrial Research, Morepen Laboratories, Dr. Reddy’s Laboratories, Ranbaxy Laboratories, Sun Pharmaceuticals and Glenmark Pharmaceuticals holding strategic leadership positions.

With diverse understanding and experience across departments like R&D, Supply Chain, Manufacturing, Project Management, Business Operations and Analytical Research he has spearheaded multiple ventures of setting state-of-art manufacturing and Quality systems and facilities, ensuring on time deliverables with GXP compliance.

Vipul is well known in the industry for his excellent technical knowledge, communication, interpersonal skills, team building and problem solving. Vipul has a proven track record of leading multiple teams and completing projects efficiently i.e. SAP, LIMS, Track-wise, Learning management system and Documentum as a function expert.

Vipul will be presenting at the first edition of the Paperless Lab Academy in India 

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The Paperless Lab Academy^® works in providing the audience food for thoughts in their digital transformation journey and in coordinating access to the latest technology offering of the lab informatics industry.

Fact is that when looking at laboratory and quality processes to be digitalised, several layers need consideration and multiple questions need answers. It is not always easy to even understand where to start and how to formulate decisions. A strong recommendation is to start with mastering your own data life cycle, and as such verify that the required regulatory compliance are observed in each steps and phases: eConnect, eManage, EDecide & eArchive.

Master you  Data Life Cycle

That is why we’ve collected a series of presentations developing further more from Raw Data capture moment to efficient use of the data for analytics, business and artificial intelligence.

Whether they are raw data from chromatographs or any other analytical instruments, they have been at the heart of many data falsification and poor data management practices found in many FDA warning letters since the Able Laboratories fraud case in 2005.

Breaches to data integrity can be avoided by creating flawless data transfer from instruments to systems, including avoiding use of spreadsheets for calculations. If you’re open of being challenged We Mr. Bob McDowall, we warmly recommend you to attend his provocative yet funny and to the point presentation: Are Spreadsheets a Fast Track to Regulatory Non-Compliance?

Consider an electronic process with validated calculations and electronic signatures 

The message will be reinforced by Mr. Mark Newton´s presentation on Data Forensics with a  pragmatic example and exercise about the importance of metadata. The information about the data that brings a deeper understanding about the quality of the final results. 

Mark is a co-leader for the GAMP Data Integrity Special Interest Group and Chair of ISPE Global Documents Committee. Co-author of “Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification” and Co-editor of the GAMP Good Practice Guide “A Risk-Based Approach to Compliant Computerized Laboratory Systems”.

Systems Integration approaches 

Yet more instruments are involved in a analytical processes and additional metadata and unstructured data are to be facilitated alongside the raw data. Andreas Steinle from Roche Diagnostic will take us through their very specific Instrument integration strategy and journey and explain how to unlock your analytical instrument data for data science 

Mr. Vipul Krishan Yamdagni, now independent GMP consultant and advisor, brings 34 years experience in the industry with major Indian Pharma organisations about digital strategy and systems integration. Vipul will share his view on  Digital Pharma Laboratory – challenge | opportunity | way forward 

Implementation experiences by time of COVID

Despite the pandemic situation and the lockdown, manufacturing companies had to react quickly to the situation, remain productive while implementing safety procedures for their employees.  Three presenters will explain us how they’ve overcome the situation, implemented solutions and taken benefit of them during this though and challenging moment.

Ms. Preeti Gaonkar, SEAP Quality Excellence Manager at SGS India Private Limited will explain how they have accelerated  their quality with digital transformation. By implementing of a Quality Management System digital system they could incorporate efficient electronic workflows to manage their quality events, audits, SOPs, quality documents and employee training records.

Mr. Albert Almajano, Chief Information Officer at Indukern Group will share their company strategy and experience in remaining focused to the implementations during the lockout situation with his presentation, Albert will show us a Roadmap to Digitalisation with Success

Mr. Sergio Nasi, Head of IT Operations Laboratory Execution at Boehringer-Ingelheim  will provide and overview of an ongoing implementation of a laboratory execution system and explain how additional challenges and opportunities the global COVID-19 pandemic have meant to the project implementation. Sergio will help us to Define your own pathway to the paperless QC laboratory: lessons learned from an ongoing project

Data Analytics and Artificial Intelligence

Toni Manzano, Chief Science Officer, R&D Director and Co-founder at Bigfinite brings a strong experience on data analytics, machine learning, artificial intelligence and sound knowledge on all related algorithms and statistics concepts behind. A unique opportunity to listen to an AI specialist with strong domain knowledge of the manufacturing industries.

Do not miss  the opportunity to benefit from his presentation and learn about Data Centricity: What is behind the AI implementation in Pharma

Dr. Lloyd F. Colegrove, Director at  Dow Chemicals, now retired and consultant, has spent 7 years in Polymer Research in Dow (R&D and TS&D) before moving into Manufacturing in an Analytical Improvement role and then a Quality Leader for five Dow businesses before moving to help establish a new capability called Fundamental Problem Solving, where top chemists and engineers work on complex, often multi-effect, plant problems. With this established, he refocused his efforts working to establish the data initiatives that support this work. Lloyd´s talk “Digital Transformation in the Chemical Industry. The Devil’s in the Details” will feature artificial intelligence as an example of a key future value delivery mechanism in digital transformation. The road to installing AI in the Chemical Industry is fraught with challenges and many dead ends.

Those are the topics and presenters  that you should expect to listen to and discuss about during the Paperless Lab Academy 2020 India online event.

Make sure to Register  for you to access the virtual event platform !

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Supported by the success of the European Editions and our sponsors,  the idea to run editions in India started to take consistency in 2019.

Behind the Scene of the PLA

If you are new to the Academy, you should know that behind the scene a young European consultancy firm, NL42 Consulting, dedicated to supporting companies in digitalising their laboratory and quality  processes is operating. NL42 born in 2012 and we soon realised that a learning platform for our customers would be really welcome. Senior Domain experts are behind this learning platform where scientific data management matters and Labs Informatics industry meet together.

So we build on a platform where to find further information on paperless projects, where to gain knowledge from though leaders, understand the offering from the software industry, discover innovative latest solutions, learn about newest concepts and methodologies, share experiences on digital strategies, scientific data management, requirements and compliance.

The cancelled 2020 live first edition in India

We were then ready to go for our very first in edition in Hyderabab by November this year. We visited
Hyderabad in November 2019 by the time of the Diwali and had just amazing time while staying at the Taj Krishna. Of course, we made a tour of hotel selection and finalised our process with the Novotel Congress Center. Due the pandemic situation, we ought to say the Novotel has been extremely comprehensive and help us to extend the contract to 2021. Anyhow, meanwhile we had to cancel the European edition planned by April 2020, and when recovered from the impact, we built on enough courage and energy to go for an Online edition.

What should you expect from our Online first Edition In India

The Paperless Lab Academy has gone paperless a while ago and all the logistics, information, agenda, schedule, sponsors content and interaction with attendees where already ran through  dedicated app. So in a way it was easy to think about using an App to support us.

Now, you can imagine that we have surprised or maybe even scared some event app vendors with our  selection process approach. As per laboratory systems solutions selection, following our own recommendations to our customers, we built on a solid list of technical, users and business requirements and then planned the implementation phases and validated the information workflows within the new virtual platform.

So the plan is for you to access the presentations and sponsored workshops, interact with your peers and colleagues, attendees, speakers and contact our sponsors at their booth.

Once registered, you’ll have access to the virtual platform on your browser and also to an App version for your smartphone for easier chatting and follow up of the sessions along the 3 days event.

Do not miss the great pool of speakers we have put down for you. Topics will be all about Scientific Data Management from the most adequate raw data capture to Artificial intelligence.

Note that the Event App will be launched by Wednesday November 18, 2020 and will remain open till December 16, 2020.

The post Paperless Lab Academy® lands in India appeared first on .

Paperless Lab Academy® main goal  is to feed the laboratories managers and directors with relevant content to support the digitisation of their analysis and quality processes. PLA aims for providing sound insights on how to build digital transformation strategies and plan for successful implementations, how to drive the change and influence positively the human factor.  Finally, PLA is the platform to meet with industry and the thoughtleaders, discover the latest solutions and find the right partner to collaborate with.

Paperless Lab Academy® had to make a final decision about the 2020 European edition of the congress. When the first signs of the pandemic were tangible in Europe , we thought that postponing our 8^th edition to beginning of June was the right decision. Unfortunately, the evolution of the situation in Italy and the delayed waves of the pandemic reaching the rest of Europe, are forcing us to accept that the new date is not feasible for various obvious reasons.

Given the current circumstances, we have now unfortunately decided to cancel the 2020 European edition.

We would like to welcome all of you in April 27 & 28 2021, in the same venue with even more energy and enthusiasm.

We are running this yearly project with all our passion and will recover from this situation even stronger and eager to stick to our reputation and standards of quality event.

The trend of registrations of the #PLA2020 was increasing amazingly. By February 2020, the number was largely above previous editions. This signal is giving us a lot of confidence that we are building the right forum for you all, buyers and vendors, decision makers and final users, Lab managers and IT partners…

We are now working closely with our PLA2020 sponsors to propose a digital continuity during the next months and provide you interesting material.

Yet we need feedback and guidance!

Will you tell us what your colleagues and your organisation need right now, or in the months ahead? 

Please take 5  minutes to answer our simple survey – then you can leave the rest to us!

TAKE THE SURVEY

Our sponsors are the ones making the Paperless Lab Academy® possible and we’d like to thank them to stand beside us and build on a collaborative atmosphere for you all to benefit the knowledge and information available in the industry while remaining safe.

The Paperless Lab Academy Organisers

Isabel Muñoz-Willery & Roberto Castelnovo

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While an enormous number of persons are fighting and exposing themselves to risks comforting the affected ones, others are working around the clock to investigate the best ways to overcome the situation or produce and deliver necessary materials to the community.

We can just say that at the Paperless Lab Academy®, we are all in good health so far and we´re working remotely as most of you are these days.

Despite the overwhelming situation, we´d like to inform you that the Academy keeps working in line with its main goals of sharing content, knowledge and experiences about the digitalisation of Laboratory and Quality processes.

We are looking for offering you an opportunity to learn more about our activities and spend some time with useful material to study, in these days of remote working.

The PLA organisation
Roberto Castelnovo & Isabel Muñoz-Willery

Do not hesitate to contact us for any question at info@paperlesslabacademy.com  

ACADEMY WEBINARS PROGRAM

Check the Academy menu to find more about the webinars program we’re offering to you.

We´ve just ran a live free webinar about “food innovation goes digital” ran by Rik Pepermans that is now available online.

In May 2019, Bob McDowall ran a webinar titled “How a paperless approach can help Data Integrity in a regulated laboratory”. We are now offering the recording of this webinar for free.

The Osthus presentation at #PLA2019 about “FAIR DATA, DATA Catalogs, and the foundations of AI artificial Intelligence” is also available online.

ACADEMY ARTICLES 

The Academy offers articles, shares whitepapers and latest news from the industry from our monthly newsletters and socials  

The Academy articles can be found in our Academy blog

#ScientificDataManagement #LabInformatics #DataIntegrity #DigitalTransformation #InternetofLabThings

ACADEMY ON-DEMAND

Most of the presentations of the previous European editions are available on demand

• #PLA2015 – Managing the Change Process
• #PLA2016 – Finding the speed to innovate
• #PLA2017 – 2020 Roadmap for digital convergence
• #PLA2018 – Empowering the eData Life Cycle: eConnect, eManage, eDecide, eArchive
• #PLA2019 – #eDataLifeCycle@Work

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Worn-out, yellowed notebooks, overstuffed with taped-in readouts and protocols, can be found in life science labs all around the world. Traditionally, scientists have had to first record their data on paper, then duplicate that data into a spreadsheet for further analysis, re-enter the data into an electronic file or email to share it, and sometimes even re-enter it into their lab’s lab management software.

All of this manual data entry is time-consuming and takes scientists and managers away from the science itself. What’s more, each step of manual data entry introduces another opportunity for manual error. And after all of that effort, paper notebooks run the risk of being damaged, lost, or even simply accidentally left behind during a critical procedure.

The Solution: ELN

ELNs are the natural solution to these problems. They provide a reliable, digital record of what happened in any given experiment and can incorporate graphs, tables, images, figures, etc.  Data is captured, manipulated, and analyzed in one central location, reducing the chance for human error, the time required for analysis, and the busywork that takes scientists away from actually doing science.

However, a software solution should do more than just address the inefficiencies of manual record keeping. Software should be better than merely an electronic replacement of paper and should be flexible in the face of iteration, rather than breaking when innovations arise. Scientists deserve modern software that fosters insights, supports collaboration, and drives predictive and adaptive planning.

The Benchling Difference

Benchling rises to this challenge. Benchling is a fully unified platform to centralize and standardize all R&D data and is built for the complexity of modern research modalities and R&D processes. Its flexibility enables you to rapidly iterate on R&D workflows through a platform that’s easy to configure, integrate, and extend. Benchling was built in the cloud from day one to serve as a single source of truth for your R&D organization, through a seamless suite of applications (Notebook, Molecular Biology Suite, Registry, Inventory, Requests, and Workflows).

This means that scientists no longer have to move data between disparate systems, and records are always contextualized as part of an end-to-end experimental history. For example, scientists can embed the plasmids they used in their experiments directly within their Notebook entries. Other scientists can then access the entry, click through directly into the plasmid, and even see which freezers contain cells that express that plasmid. And what’s more – Benchling is built to be as intuitive as consumer software. Taken together, the power and usability of Benchling mean that scientists use it as an active tool in their research, not a static archive of data. Drive faster, smarter decision making for your research organization.

Silver Sponsor Exhibiting at PLA2020 Europe
Learn more at www.benchling.com 

Lauren Shields, Ph.D. – Head of Customer Success

Benchling is the first R&D cloud platform powering the life science industry and helping the next generation of scientists make breakthrough discoveries faster than ever before. Replacing outdated pen and paper processes, Benchling offers unified R&D solutions purpose-built for biotech, including Notebook, Molecular Biology, Registry, Inventory, and Request & Workflow Management. Benchling is used globally across the largest multinational pharmaceutical corporations, emerging biotechnology companies, and major research institutions. 

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I have always been fascinated by Sci Fi representation of labs. The voice of a central Artificial Intelligence can be heard in the laboratory to provide services to laboratory workers and trigger general alerts in catastrophic movies. I think there is some truth in this imagination of the laboratory of the future, but it is a safe bet that the laboratory 5.0 will not look exactly like what is imagined. Let’s investigate!

Internet of Lab Thing: What are we familiar to?

We already live today with many systems that have enabled the digitalization of the laboratory:

• Internet allows access to knowledge bases, and enables systems communication
• LIMS, ELN, and all other software and database systems make it possible to enhance data, manage them and ensure their quality and traceability
• The laboratory processes are formalized, through operational, quality and automation oriented methodologies, generally transcribed in the laboratory’s QMS
• The instruments are becoming more and more automated, from the gas chromatography machine that automatically draws chromatograms, to new automatic sample collection machines, for example

We have adopted these examples for a long time in our daily laboratory life, and we now perceive the possibility of going further in the digitalization of the laboratory.

Internet of Lab Thing: What do we already expect for tomorrow?

Today we expect a lot from artificial intelligence, in its ability to analyze data, make decisions, make complex calculations much faster than humans.

Databases and the value of their data are fueling the development of big data, data science, and machine learning to exploit data beyond everything that has been done so far.
The good old robots already widely used in industrial production are evolving towards the concept of “cobots”. We will also have to familiarize ourselves with these “collaboration robots” that are intended to work closely with humans, not separately.
As for the Internet of Things, it is already part of our daily life at home and has not yet entered the laboratory environment. This Internet of Laboratory Things (IoLT) will reveal the potential of all these technologies, in particular by allowing the interconnection of intelligent systems, sensors and machines.

Internet of Lab Thing: So, what’s next?

The complete integration of all these technologies will lead the laboratory to the next stage of its digitization. And the integration of every lab components together will be made possible thanks to the IoLT: from humans to instruments, from instruments to databases, from sensors to central AI, etc. Sensors and lab instruments will be connected to the network and able to communicate with the whole laboratory information system. Humans also, on the same level as AI, will be able to supervise, communicate, control data, sensors, instruments, etc. That’s IoLT.

Internet of Lab Thing: “Connected humans”

Human-computer interactions will be pushed to their climax with full adoption of technologies such as :

• Virtual and Augmented Reality
• Speech recognition
• Gestures control
• Biometric authentication: fingerprints, voice prints, facial recognition. Even all together for very secure systems are fully possible
• Etc.

All these technologies are key accessories connected together thanks to the central IoLT technology.
Humans can therefore also be connected remotely. This leads to few or no humans physically present in the lab, only machines will remain there, and humans will keep control of them from their chairs at home.

Human consideration in all of this

Human is replaced in performing risky, repetitive tasks, and where he can also make mistakes. Human is also replaced wherever the “machine” is more efficient than him: in tasks that require physical strength, high computational or decision-making capacity, etc. But he is not replaced in his most interesting and rewarding tasks, he remains the master and configures the machines, initiates the systems, maintains them, supervises them, and values their results. He remains present from the initiative of the existence of these systems to the exploitation of the results.
Furthermore, each man can certainly be replaced by 1 machine capable of doing 10 times what a human is capable of. But each human can then supervise / control / etc. 10 of these machines. The ROI is easy to estimate, either on its financial or human dimensions.

From Sci Fi to Reality

A centralized artificial intelligence will have access to the ubiquitous cameras in the laboratory, and to all sources of knowledge and control: the AI will be connected to the sensors installed in the building, it will also have access to all the databases, etc. It will have in the end a capacity of surveillance and control at the height of what authors of science fiction have already imagined, like the Red Queen in Resident Evil films, a lab version of HAL 9000 in 2001: A Space Odyssey to cite only these (and certainly not the most reassuring). But are people willing to accept this? This is undoubtedly a new change which
can be difficult to adopt. But what is the point of worrying if in the end there is no longer any person physically present in the laboratory.

IoLT: the key link for integration into laboratory 5.0

Humans are already all interconnected with each other and with knowledge bases thanks to their Smartphones. It is a cultural fact perfectly acquired by modern society. These intermediate systems for interconnection will be deployed in all ecosystems, and laboratories will not be spared. Interconnection systems will appear to interconnect the laboratory in its different components. Whether the laboratory equipment is natively connected or not to the lab network, they will be equipped with totipotent communication accessories. These accessories currently have a singular name: “IoT gateways”. This
name is a bit reductive in my opinion, it should probably be seen as a “Smartphone” for equipment, for databases, for central AI, for humans in the lab. These IoT Gateways are the building blocks of the IoLT, the final link that will soon allow the integration of physical, digital, and human systems. Paving the way for a synergy of systems whose potential surely exceeds us. For the time being.

A beginning

The lab 5.0 will arrive.
The IoLT will play a major role as a key link for the lab integration of systems and technologies, and it will be a revolution in the way of working and even living. Are we ready to accept this? This will again be a new challenge with regard to the changes to be adopted.
If you thought the lab’s “digital revolution” was getting closer to its objectives, I think there’s still a lot to do, with a lot of surprises to come. We may still be at the very beginning of what we call digitalization.

Connected Labs is sponsoring and exhibiting at the Paperless Lab Academy 2020 European edition and will be available for you to contact

Thomas Perraudin, Co-Founder of Connected Labs 

Thomas is an experienced entrepreneur and computer scientist, fond of technological innovation. Founder of Cerebellis, a company specialized in software development for biology and health industries. He partnered with SoftNLabs in 2019 to create a new IoLT solution: Connected Labs

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Laboratories of regulated industries like BioPharma, Medical Device or Cosmetics need to focus on regulatory compliance in most aspects of their operations. With an increased number of Form 483s issued in 2019 the main observation citation was “Procedures applicable to the quality unit shall be in writing and shall be followed”. But compliance-related activities are time-consuming and considered non-value adding activities—generating costs and delaying product releases. Meanwhile non-compliance can lead to product halts, recalls, fines and damage the brand reputation.

Organizations must therefore investigate smart ways to minimize Compliance Risk

The solution to minimize compliance efforts and risks at the same time is to maximize automation in the laboratory. This can be achieved through integration and standardization, leading to higher lab efficiency and productivity, reductions in errors and compliance efforts, and reduced costs and waste.

While the main FDA observations were around procedures, the good news is that they are an easy target for improvement by automation as the execution of procedures includes a significant amount of routine tasks. Lab technicians use procedures that they follow and document step-by-step, and then the data will be reviewed, and Certificates of Analysis issued for batch release.

Procedure Management  solution to reduces Compliance Risk

An advanced standards-based Procedure Management solution allows the users to easily follow procedures in the
lab without the need for paper copies. It also enforces a step-by-step execution and allows for automated data transfer from the instruments, as well as an easy recording of data and observations on-site and meta-data extraction. Additionally, it provides an automated review and approval process, including review-by-exception and deviation warnings.

These capabilities allow lab organizations to work more efficiently, ensure data integrity and quality and effortlessly achieve Operational and Compliance Excellence.

BIOVIA WHITE PAPER : PROCEDURE MANAGEMENT SOLUTION SIGNIFICANTLY REDUCES COMPLIANCE RISK

Biovia is a gold sponsor, exhibitor at the Paperless Lab Academy 2020 and will also run a workshop  >> see about Why Digitalize my QC Lab when it’s already electronic?

Dassault Systèmes, the 3DEXPERIENCE Company, provides business and people with virtual universes to imagine sustainable innovations. Its world-leading solutions transform the way products are designed, produced, and supported. Dassault Systèmes’ collaborative solutions foster social innovation, expanding possibilities for the virtual world to improve the real world. The group brings value to over 220, 000 customers of all sizes, in all industries, in more than 140 countries.

Powered by the 3DEXPERIENCE® platform, BIOVIA™ provides global, collaborative product lifecycle experiences to transform scientific innovation

BIOVIA solutions create an unmatched scientific management environment that can help science-driven companies create and connect biological, chemical, and material innovations to improve the way we live

www.3DS.com   

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