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The Paperless Lab Academy® European Congress invites you to continue this conversation. The PLA’s unique format is primarily designed to provide you with all the information you need to be confident about how to make your projects a success. For your transformation journey we focus on talent and technology.

Which topics can you expect to discuss at this Paperless Lab Academy® 2023 Europe congress edition?

The list of topics to cover when speaking about the digitalisation of laboratory and quality processes is pretty extensive. However, at every edition we aim to design an agenda to allow the coverage of the whole digital data lifecycle

• About the future of the laboratory within the industry 4.0
• Artificial Intelligence in the GXP environment
• Automation in QC processes
• Cybersecurity Awareness
• Demystification of the Cloud-based solutions
• Mastering your data for efficient scientific data management
• How to apply the FAIR principles
• The relevance of a data transfer strategy when replacing legacy systems
• Practical sessions about Audit trails, Data Integrity, Instrument integration, Resources Management, SAAS solutions, harmonisation, Computer System validation…
• How to successfully implement laboratory system solutions at global scale
• Change Management, Talent and skills.

What makes the Paperless Lab Academy® so unique in its format?

The PLA programme consists of a combination of plenary sessions and parallel workshop sessions. In the plenary session, speakers share their experiences, lessons learned and recommendations. Others aim of sharing their expertise, educating the audience while presenting use cases. The sponsored workshops run in parallel to a maximum of three sessions, with participants free to choose which one they would like to attend. During these workshops, the premium and gold sponsors present their latest solutions and share their expertise on a specific topic.

The Paperless Lab Academy® pillars are:

1) Content-rich presentations where you can hear from others about their own journey and strategy and learn from tech experts about fundamentals of certain concepts and principles

2) Sponsored workshops where you can get the most from subject matter experts

3) Exhibitors and networking sessions where you can meet potential technology and expert partners.

We look forward to returning to Lake Maggiore to the wonderful Grand Hotel Dino to celebrate our 10th European Live edition.

Be prepared to boost your digital capabilities and get the most out of 2 intense and entertaining congress days.

Don’t miss this very special edition. Book your seat!

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Cloud solutions have come of age and have enormous potential, offering resilience, security and scalability – all quickly and at low cost for implementation and maintenance. Leading pharmaceutical and life sciences companies are discovering the potential of the cloud by enabling analytics, shortening innovation cycles and standardising processes across global operations, among other benefits. During the pandemic COVID, cloud technology enabled pharmaceutical companies to deliver the COVID -19 vaccine in less time because it does not need to be reinvented and can fly indefinitely.

Although there is widespread belief in the value of the cloud, there is often a lack of clear understanding of how to maintain a validated and controlled state of cloud solutions by solution providers and users (pharma and life sciences companies). This leads to misguided strategies and incorrect implementation or too much validation and documentation; sometimes repeating everything the cloud solution provider has already executed.

Selecting the right cloud deployment model can be challenging when considering the various regulations and standards that apply to the GxP environment, such as 21 CFR Part11, EU Annex11 GDPR, PCI DSS, HIPAA, ISO and many more. The following are the available cloud deployment models that can be used in the GxP environment depending on the risk, complexity, and size of the computer systems.

Cloud-based solutions in GxP Environment: one solution for every need

Public Cloud Deployment

These deployments are hosted on public servers that are available over the internet. The cloud service provider maintains and manages all available resources in the cloud. Therefore, companies that opt for a public cloud do not have to make large investments in hardware and software and do not need to hire additional staff to manage them.

The disadvantages are data security and privacy concerns and reliability issues, as the same server network is open to a large number of users, as is the case with public cloud services used on a daily basis, such as email services.

Private Cloud Deployment

These deployments include hosting the cloud infrastructure on-site or in a cloud service provider’s data centre. In-house staff maintain and manage all available resources in the cloud. Companies must have technical staff on hand to deal with any issues that arise during the operation of the private cloud. This model allows the cloud services to be integrated into the company’s infrastructure. This model offers more control, customisation options and high security.

The disadvantage is the cost of keeping qualified personnel as well as infrastructure costs.

Hybrid Cloud Deployment

These deployments combine public and private clouds. Here, the company uses the public cloud but also has its own systems on site and creates a connection between the two. They work as one system. This is helpful when costs and security need to be managed efficiently, as it allows the requirements of a private cloud to be combined with the benefits of a public cloud. This allows local applications with sensitive data to run in parallel with public cloud applications.

The disadvantage can be the cost impact if the right services are not selected in this model and if the separation of public and private data is not done following correctly security, compliance and auditing requirements.

Community Cloud Deployment

These implementations involve the sharing of infrastructure between multiple groups/organisations. Data is still segmented and kept private except in areas where shared access has been agreed and configured. Organisations that have unified business needs choose to join the community cloud, e.g. government organisations, universities, etc. It enables cost-effective collaboration with the establishment of a low-cost private cloud.

The disadvantage is that security and segregation of data can be difficult to ensure.

Having gained a full overview of the cloud-based solutions that could be deployed in a GxP environment, what steps are recommended to manage the cloud service provider’s compliance?

• Cloud Service Provider assessment, evaluation & audit
• Supplier procedural requirements for
  • Data Migration
  • Incident Management & Disaster Recovery Plan
  • Data Retention and archiving
  • Infrastructure Maintenance
  • Change Management
  • Release Management
  • Access Management
  • Customer Support
• Leveraging Validation/ Qualification performed by Supplier
• Continuous monitoring and assessment of Cloud Service Provider
• Robust business contractual agreement on services & quality of cloud service provider with listed recommended inclusions:
  • Prior notices for scheduled maintenance down time
  • 45-60 days prior notice before Major/Medium release in the Production after validation completion in the validation environment. This can be used by the regulated organizations to perform testing and validation of the new version of cloud solution before the new version is released to the “Production” environment
  • Customer support 24h, 7 days a week
  • Supplier must ensure backup/restore/Disaster Recovery of data
  • Data transfer/access compliant with GDPR and other applicable local regulatory requirements
  • Data removal upon termination of contract
  • Supplier’s confidentiality obligations, Data Protection, Subcontracting, Audits

Validation of Software as a Service (SaaS) on Cloud

When using validated SaaS (Software as a Service) in the cloud, a risk-based approach must be taken. These solutions are also referred to as pre-validated SaaS. Organisations can perform minimum validation approach to using pre-validated SaaS in a number of ways, depending on their internal business processes and the regulatory requirements they need to comply with. The table lists the recommended validation steps that should be followed when using pre-validated SaaS as-is (GAMP category 3) or with additional workflow and configuration changes (GAMP category 4).

Mrs Neeru Bakshi, Founder  at Tech Qualitas

Regulatory and technical software is nothing without a team of data and science experts at its core. Neeru is one of those ultra-valuable veteran data experts that digs into the nitty gritty of regulations, guidelines, and systems and makes sure the organization is up to date and on track with any new technical developments in QA, validation or any other industry standards.
Neeru Bakshi has more than with 20 years’ experience in the pharmaceutical and Life Sciences domain. She worked as Validation/QA Lead, Project Manager/Lead, and as Business Analyst for various cloud solutions and systems such as Oracle Life Sciences Applications for Clinical Trails, SAP, GLP systems, Electronic Submissions, Pharmacovigilance Systems.
Neeru is well versed in regulatory standards and guidelines; 21 CFR Part 11, Computer System Used in Clinical Trials, GAMP5 guidelines, EudraLex Volume 4 Annex11 along with knowledge of European data protection laws and practices and understanding of the GDPR. She has experience and interest executing harmonization, development and implementation of Global Quality and IT/CSV Policies/ SOP’s/ Guidelines across the organization level. She also has experience in the pharmaceutical industry audits of validated computer systems, and supporting clients in such pharmaceutical industry audits, whether they be internal audits, sponsor-driven audits, or regulatory agency audits.

Tech Qualitas is a quality-driven service partner focused on risk minimization. Our team have more than 40 years of experience handling complex projects at different scales. We are serving the pharmaceutical, biotech, medical device, and CRO companies by providing compliant outsourced services, validation technology solutions support and development that improve performance, data integrity & privacy controls, and compliance. Tech Qualitas experts have thorough understanding on Computer System Validation, Auditing Services, Sterilization Process Validation, Pharmaceutical Microbiology and Contamination Control, QMS Designing and Consultancy services, SaaS validation for service provider and customer, and many other compliance services.

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The Pharma industry has started to embrace the FAIR principles. With considerable progress, the transformative shift from an application-centric to a data-centric perspective remains very much a work in progress on the ‘FAIR journey. It is quite surprising that the FAIR and the Data Quality communities seem to be rather disconnected. Interestingly, the obvious relationship between FAIR data and Data Quality has not been considered so far. In this review, the authors show how FAIR implementation metrics, maturity indicators, can be deployed alongside assessment of data quality. This combination of FAIR and Quality implementation is likely to maximise the value of data generated from research, clinical trials, and real-world healthcare data, which are essential for the discovery and development of new medical treatments.

Many unresolved challenges are to be tackled by the FAIRification efforts in the life science industry. A crucial challenge involves not only building a technical infrastructure, but, more importantly, also harmonising the needs of multiple, diverse stakeholders. This includes training and managing the necessary cultural change, within an organisation and beyond, to the network of suppliers, regulators, stakeholders, and, ultimately, patients.

The adoption of the FAIR data principles at scale has led to a substantial transformation of the data management value chain in the life science Industries. This has resulted in building strategic roadmaps to drive digitalisation, creating highly connected and analytics-ready data sets. Many biopharma companies have implemented a significant number of tactical and operational projects to demonstrate the feasibility, practical impact, and business value of data FAIRification.

Two example case studies from Roche and AstraZeneca follow.

FAIR implementation at Roche

A wealth of clinical trial data has been collected by Roche over several decades across many therapeutic areas. In 2017, a collaborative, cross-functional (research and product development) program was launched to transform the data management practices and corporate culture of the company to accelerate the generation of meaningful scientific insights through FAIR and shared data. In addition, a significant investment in tools, technologies, and semantic infrastructure has been made to support the transformation. Although the long-term goal is to FAIRify all data sets, the company embraced a ‘learn-by-doing’ approach by launching a series of use cases prioritized by a board of scientists taking small chunks of data to answer specific scientific questions. By doing so, issues and challenges associated with the FAIRification process of legacy data were identified. Through these initial projects, a deeper understanding of how to improve and build the ecosystem of the company to make data FAIR at scale was achieved. It was found to be crucial to learn how to foster a ‘data citizen’ mindset within the organization.

FAIR implementation at AstraZeneca

Competitive intelligence, clinical study design, and translational medicine efforts have been the primary benefactors of data FAIRification efforts at AstraZeneca. Within the Oncology Translational Medicine Therapeutic Area of AstraZeneca, FAIR data implementation has focused on scientific use cases as a way to encourage greater data stewardship and reuse while solving key scientific challenges.

Few fundamental building blocks needed to be established, including implementing a persistent identifier policy,determining reference data sources as a backbone, and coalescing around a small number of domain vocabularies.¹⁹ This helped to set up the Findability and Interoperability principles.

The basic URI structure follows a template in Backus-Naur Form (BNF): SCHEME PURPOSE FUNCTION DOMAIN ‘/’ (SCHEMA ‘/’ CONCEPT (EXT)* | CATEGORY (‘/’ SOURCE)* (‘/’ TOKEN)+ (EXT) + )

The FAIR Guiding Principles

The FAIR Data Principles were designed to ensure that all digital resources can be Findable, Accessible, Interoperable, and Reusable by machines. The Principles act as a guide to the kinds of behaviours that researchers and data stewards should increasingly expect from digital resources. See introduction to FAIR Principles presentation at last #PLA2019 edition

The FAIR Principles are aspirational, in that they do not strictly define how to achieve a state of “FAIRness”. They describe a continuum increasingly rich (meta)data features, attributes, and behaviors that move a digital resource closer to that goal and support the automated discovery and reuse of important data resources. see full article: Evaluating FAIR maturity through a scalable, automated, community-governed framework

Those articles are developing on initiatives started and now maturing in the Life Science and most precisely Biopharmaceutical industry.  However, the FAIR principles and the goals to be achieved by implementing them are to be considered nowadays by any other industries generating massive number of scientific data every day.

In conclusion, there should be more profound reflexions when initiating Paperless projects, digital transformation journeys. Looking back to your own data life cycle and designing first your data workflow

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Missing the human interaction too much

What will make this edition very special beside the fact of returning to see you all, is the strong desire to ease discussions.  At the PLA, like everyone, we are tired of static virtual events, static team online meetings and we are really missing real discussions with the audience. We want to hear from you and we want you to get the maximum out of it.

As such the agenda structure will be revised allowing much more space for Q&A sessions and panel discussions.

in order to stimulate the discussions we have put together a series of topics with our keynote speakers. The Paperless Lab Academy® is all about digital data management in manufacturing company. Whether the final products are to be quality controlled or proper laboratory services, whether the department is R&D, IT, Operational Excellence or Quality, whether the major concern is efficiency, integration, harmonisation or compliance, we aim at covering them all at its best for you to get a better understanding and bring back to your team meaningful information.

Science, Technology and Data

The word around us is evolving at incredible pace and companies need to embrace this evolution. Speakers from Roche, Novartis will share their experience in bringing different functions, process, and products into the digital world.  Igor Menghini , Head Software Product Management at Roche will also share their experiences in assessing technologies, their concerns and approaches to ease implementation. 

As such Vijay Raju, Global Head of Analytical R&D at Novartis AG, will share updates in their user centric approach pursued in engaging the scientists to understand their pain points, defining future solutions and designing the prototypes. Everyone is also looking for updates on their very smart approach for ensuring the buy-in of the laboratory users, through a digital pilot laboratory which everyone can visualise as the new processes to be implemented, they get user acceptance before full scale implementation. 

Cloud and Security

Cloud has immense potential, but most companies are only scratching the surface. The adoption of cloud principles, such as infrastructure as code (IaC) and security as code, help to automate good-practice (GxP) compliance processes so the organisation can move quickly while staying secure and compliant. See as example Automating GxP compliance in the cloud: Best practices and architecture guidelines.

Security measures available are multiple, like segregation of protected or sensitive data from non-sensitive data, encryption of  sensitive data while in transit or also at-rest, robust access control with use mechanisms that define privilege access, multi-factor authentication, etc. 

Considering SaaS solution providers vs on-premise ones is today a necessary move toward newest digital dimensions. 

Digital Transformation Journey 

Simon Brem, Head Laboratory Systems and Standards at Carbogen Amci will share pragmatical experience on their digital transformation journey. Their analytical labs in Switzerland are mostly paperless for more than 10 years now and currently working on a global rollout of a new LIMS system. Simon Brem will elaborate on ‘soft and hard’ key factors and learnings for project success. He will also explore the benefits of agile business process design and discuss on the benefits of external expertise and benchmarks

From last Paperless Lab Academy® edition in India, SGS already shared with the audience that like many life sciences organisations, their quality environment was heavily paper based and document centric. They needed a digital system that could incorporate efficient electronic workflows to manage quality events, audits, SOPs, quality documents and employee training records. In order to achieve an ambitious timeline for the rollout, they preferred to opt for the out-of-the-box option with minimum customisation. In this precise edition, Ulrich Martens, Global Head Quality, Business IT & Business Excellence at SGS will share their experiences on global implementations, the impact of the human factor and change management, the relevance of establishing valuable, strong, trustful long term relationship with their solutions providers.

Typically , digital winners rely on scalable software-based business models that can rapidly scale up the number of users and revenue with only minimal changes to the underlying cost structure.

Finding the true value of lab and plant data

Lloyd Colegrove, Data Services Director at Dow Chemicals ( now retired and consultant ) will share their journey.The journey towards a major chemical company’s vision for the artful use of large structured and unstructured data sets in real-time plant operation and problem solving is a story of technology, salesmanship, and the hard work of convincing a company in love with Excel spreadsheets, and problem solving after-the-fact, that significant value lies in already collected and often under-utilised plant data sets. Part of the story includes the application of artificial intelligence, but AI is not the solution, it is a solution.

Through the use of volunteer audience participation and a few artful stories, this talk will discuss real-time analytics success stories that are actually simpler than “AI” infused solutions, discuss where AI fits in the chemical industry, and highlight some experiences from 30 years of engagement in chemical manufacturing that can bring tremendous bottom-line value to your chemical operations.

Rethinking strategy for the post pandemic era

McKinsey survey confirms that the future will belong to companies that put technology at the center of their capabilities, and leadership mandate. The pandemic has impacted the pace of business, forced companies to revisit and even reconsider their business model.  Technology capabilities is critical to companies’ COVID-19 exit strategies as well as to what comes next. CIO have a stronger voice within the organisation and CFO are allocating budget for making digital and technology investments across the business model.

We’ll be looking to discuss further with you about the pandemic effect on your daily work?  was there a digital fix to alleviate the team ? What works better than before? What didn’t? Can we get better prepared for what might be coming next?

Compliance, Quality Standards and Integrity

It goes without saying that scientific data management requires of special attention regarding integrity and compliance. A lot can be discussed here, further more than just ALCOA, FAIR, Archiving, Backups, etc. Mark Newton  and Bob McDowall,  our keynote speakers subject matter experts will take us through the concepts and more over through real cases.

They will be running a specific panel discussion in which you need to be prepared to be challenged and best to summarise this space is the title of Bob McDowall presentation The Answer’s Digitisation, What’s the Question? 

Bob is an analytical chemist with 50 years of experience, including working in the pharmaceutical industry for 15 years and afterward working for the industry as a consultant for 29 years. Bob has been involved with the automation of laboratories since 1980 and has over 35 years experience of validation of computerized systems and is the author of a book on the validation of chromatography data systems.His latest book is Data Integrity and Data Governance: Practical Implementation for Regulated Laboratories published in 2019 by the Royal Society of Chemistry. He is a member of the GAMP Data Integrity Special Interest Group, contributing to the Records and Data Integrity Guide in 2017 and two Good Practice Guides. Bob McDowall is also the author of the “Questions of Quality” and “Focus on Quality” columns in LCGC Europe and Spectroscopy magazines, respectively.

Reading current journal, scientific magazines and listening to presentations about automating a laboratory, you could be forgiven the assumption that many organisations are at the cutting edge of technology. However, when you see many medium and small sized laboratories nothing can be further from the truth. Many laboratories and regulatory authorities have forgotten the need to keep current with technological advances. Therefore, regulated GMP laboratories must automate and remove paper if they are to survive in a stringent data integrity environment. How should we change this? just you do it! comments Bob McDowall

Mark Newton is an independent consultant in laboratory informatics and data, data integrity, validation of computer systems/spreadsheets, analytical instruments and LIMS/ELN. He has 30+ years of pharmaceutical experience in QC Labs, computer systems validation and lab informatics at Eli Lilly. Mark co-lead Eli Lilly’s data integrity remediation program for QC Labs worldwide in 2012, consulted and audited several Lilly sites preparing for data-integrity focused inspections. He 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”  Schuessler, Newton, Smith, Burgess, McDowall. Pharm. Engineering, Jan/Feb 2014. Co-editor of the GAMP Good Practice Guide “A Risk-Based Approach to Compliant Computerized Laboratory Systems” Nov. 2012.

Commitment to healthy measures

We know that coming back to event like the Paperless Lab Academy® is the one of the first to coming back to normal life together. Above all, laboratories have been put under the microscope in these past months and an amazing international work has enabled the production of vaccines in record time. the knowledge sharing, data exchange, data process and automation has enabled this speed of answer to the world. The laboratory informatics industry is booming with amazing modern solutions that can really be the answers to the laboratory needs today. Because the lab of the future is today!

Come and join us!

Join the experts, your peers, the solution providers… Come and join the discussion! Register Now

They have confirmed their presence

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Program your own educational program

You are welcome to access to each and every session. The full list of available session from the academy are to be find at @academywebinarprogram.   The sessions are recorded and available on demand.

Academy Webinar: Journey to a Digitally Transformed Laboratory 

This Academy Webinar from Thermo Fisher Scientific  discusses about how to develop a realistic strategy for your digital projects.

Across all scientific industries, organizations are looking at their digital transformation journey and trying to map out the key strategies to achieving a fully digitally enabled laboratory. The key to creating and implementing a digital strategy is determining where efficiencies can be made and where technologies can provide a competitive edge.

Looking at the most recent technological advancements, and those yet to come, organizations need to understand where they are in their digital transformation journey and how they can continue to move forward. Organizations are looking to implement more effective instrument connectivity, advanced software that can streamline processes, and tools and techniques to increase data efficiency.

Whether you are just starting to implement a strategy or are almost a fully digital laboratory, it is important to look at your current data infrastructure and your laboratory needs to develop a realistic strategy. With expertise in integration, data visualization, services and software, Thermo Fisher Scientific can help. Join the upcoming webinar to learn how to build a strategy that makes sense for your laboratory.

Academy Webinar: How to easily find and access your documents anywhere, anytime 

A presentation from DEXSTR that demonstrate about finding your data instead of desperately searching them.

With the explosion of data volumes collected, the ability to process it becomes a real challenge.

To address this challenge, DEXSTR presents their new offer Inquiro lite. They discuss about how to Easily find your data and retrieve your siloed data from one single location.  You’ll improve your productivity by leveraging your untapped data, increase the global collaboration efficiency by sharing data in information-driven manner and monitor your data by creating your own dashboards

Academy Webinar: Data Review in the laboratories of the pharma industry

A presentation from Inpharmatic about the benefits of a paperless scenario for raw data, with or without a LIMS.

The final version of the guideline PI 041-1 (1 July 2021) “GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS” details the Authorities’ expectations for the Review of electronic data (§9.8).

Based on this guideline, during the webinar we will talk about the importance of data review in the data lifecycle, how to be compliant with data integrity requirements and the essential checks to perform during a data review. like, consistency between data on the notebook/analytical worksheet and analytical request/order, validity of used reagents or accessories, availability of Raw data, etc

We will also make a comparison between the current paper-based data review and the electronic data review and will give participants important advice to improve the efficiency and the effectiveness of the review.

This include the benefits of Exception Reports: validated search tools that identify and document predetermined “abnormal” data or actions, which require further attention or investigation by the data reviewer.

More webinars are available at #academywebinarsprogram   

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Program your own summer educational program

You are welcome to access to each and every session. The full list of available session from the academy are to be find at @academywebinarprogram.   Below examples of you can find in the Academy webinars program

Academy Webinar: Planning a Tomorrow-Ready QC Lab with Caliber Technologies 

This Academy Webinar from Caliber discusses the critical digital changes to be brought in to the QC lab to make it Tomorrow Ready. At present, Pharma companies follow a standard approach towards the tools they implement and envision for their lab. The focus is still limited to removing paper-related obstacles and reaping a finite number of short-term benefits. But there can be more to lab digitalisation. A paradigm shift in approach is needed to make lab digitalisation more sustainable by adopting futuristic tools for predictive analysis, ensuring that the lab meets quality and productivity KPIs and generate better return of investment recognition in a QC lab.

Academy Webinar: Lab Efficiency and Data Integrity with Empower PLUS Solutions with Waters Corporation

A presentation from Waters that demonstrate how much more you can do with the systems you already have and how to plan for phased implementations and incremental extensions to automate your laboratory workflow. Many companies are not using all of the available functionality in their existing systems and you may be able to do a lot more with what you already have in place, or with small incremental expansions. Many laboratories however may be working with a mixture of standalone workstation instrument PCs, paper lab books and small networks. A major new software implementation – for example, deploying a LIMS – would need:

• CRLF Significant time and effort from laboratory personnel while your analysts are busy trying to complete their routine tasks, sometimes with limited laboratory access,
• Tremendous IT support when most IT groups are busy managing remote access and overloaded VPNs, and
• Large capital investment at a time when many companies are struggling with much reduced revenues and reduced budgets

Academy Webinar: Digital Continuity from R&D to Manufacturing with Dassault Systèmes 

A Dassault Systèmes presentation about how BIOVIA solutions help CROs, CMOs and CDMOs achieve collaborative innovation & operational excellence through Digital Continuity. The presentation discuss the key that helps organisations attain Digital Continuity and transform:

• From Product to Experience, through multi-scale & multi-discipline support
• From document based and siloed designs to data-driven and model based approach
• From siloed organisations to Flexibility in a Global Company
• From Capacity Maximisation to Cycle Time Optimisation
• From process execution to real time business impact analysis
• From Transactional to more standardised regulatory dossiers & quality

Academy Webinar: Unleash your lab’s productivity with Merck 

Presentation from Merck about the opportunities to  improve productivity, compliance, and safety in laboratory management through digitalisation. 

• How many times have you tried pulling a chemical required for an experiment only to find that someone else from your lab has already taken it? Or that the chemical just expired and you now need to wait several days to receive a new supply?
• How much did you sweat in your last audit when the auditor asked about the documentation regarding  the usage of chemicals and reagents?
• Did you know that most laboratories spend 25% of their available working time on  the management and documentation of consumables, chemicals, reagents, and equipment?
• Why do we still accept compliance and safety risks by using paper or Excel-based data capture or data transfer?

In this session, you discover the opportunities to improve productivity, compliance, and safety in laboratory management through digitalisation.

Academy Webinar: Intelligent Automation in QC Management with Accenture

A presentation from Accenture about the new challenges faced in the Pharmaceutical Industry. Before the global pandemic, the industry was already facing problems of exploding drug development costs and increasingly complex supply chain and regulatory environments, as well as downward price pressure from generics, global health systems and outcome-based pricing models. The unprecedented challenges of the pandemic forcing remote work and demanding tests, vaccines and therapies at desperate speed, only add to the challenges. To date, Quality has throttled speed to market and been a necessary, but precious, cost. Today’s business cannot afford the reactive, manual and still largely paper-based Quality processes.

It is no longer enough to talk about digitalization and automation of antiquated Quality systems. It is now a business necessity to shift the Quality paradigm. Companies need to reduce the cost of Quality and increase the speed, efficiency, and reliability of our processes.

More recorded webinars are available at @academywebinarsprogram  

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Digital Lab: A human-centric design approach to transform ways of working

Vijay has to ensure the correct execution and meet the deliverables dates expected from his team across a broad spectrum of application from small molecules, biologicals to biosimilars. Their technical R&D key accountabilities are about creating but also innovating technical product designs and processes and  supplying clinical and preclinical study materials.

Novartis aspires to build a leading medicines company, powered by advanced therapy platforms and data science. In this direction, the Technical R&D organisation within Novartis is implementing its vision for a digital lab allowing scientists to focus on real science and transforming their way of working, explain Vijay to our PLA event manager.

The presentation will provide an overview of the user centric approach pursued in engaging the scientists to understand their pain points, defining future solutions and designing the prototypes.

The overarching end-to-end design architecture and overview of some of the solutions under implementation will be presented.

The solutions include a Digital Integration Hub enabling data to become FAIR  – Findable, Accessible, Interoperable and Reusable. Introduction to the FAIR principles.

At Novartis, data as such create knowledge and provide insights enabling digital twins, predictive analytics and process automation. The presentation includes use cases that will apply these capabilities to accelerate technical development, transform knowledge management and
increase efficiency in operations will be shared.

Additionally, a very smart approach is implementing ensuring the buy-in of the laboratory users. Through a digital pilot laboratory which everyone can visualise the new processes to be implemented, they get user acceptance before full scale implementation. 

In conclusion, the anticipated benefits to the  scientific community and business will be outlined.

The post The Digital Lab at Novartis has a human- centric approach appeared first on .

 Article written with David PEYRUC, CEO, and co-founder of DEXSTR. 

DEXSTR: a Scientific Knowledge Management System company

The company DEXSTR was created in 2014 by David PEYRUC and Erwan DAVID, both of whom have a scientific background, particularly in bioinformatics and life sciences. 

Their background in the Pharmaceutical industry is very close to the scientists for whom they set up IT solutions such as electronic laboratory notebooks or “data warehouse” for Research and Development data. 

DEXSTR, is a company that publishes and develops Inquiro software. This software is an “Insight Engine” for life sciences, which allows to leverage on scientific knowledge “Scientific Knowledge Management System”. 

BASSETTI: Management of Technical and Scientific Knowledge through TEEXMA®

The partnership with BASSETTI was a natural choice, because the software published by BASSETTI, TEEXMA® is specialized in the management of technical and scientific knowledge. Inquiro’s approach is based on the analysis of unstructured data (documents, large volumes of data such as file systems, servers or even massive external data sources or BIG DATA). 

The main principle of Inquiro is to know the field of activity of its users as well as the different data sources, internal or external to the company. It will be able to connect to an electronic laboratory notebook, a LIMS, a file server, or a DMS, for example. 

Associated with the Google-style search results offered by Inquiro are data visualization tools, with graphical representations that allow you to navigate through and cross-reference the data. 

We will retrieve the documents that are in these different data sources, we will pass our Artificial Intelligence algorithms, which will allow us to detect all the scientific entities of interest to the client, such as bacterial strains that we can find in an electronic laboratory notebook, or in a file server for example. Obviously, these detections are adapted to our client. –  David Peyruc –

 Inquiro integrated as an add-on module to TEEXMA®

In the 3 ongoing projects, Inquiro is integrated as an add-on module to TEEXMA®, to add new capabilities and functionalities around chemistry and more specifically on the search for chemical entities. This module, offered as a complement to TEEXMA®, allows you to search for molecules by identifying all the names used for each molecule, whether textual or visual. Inquiro and TEEXMA® are closely connected via connectors that allow them to exchange key data essential for information retrieval. The 3 ongoing projects are mainly, but not exclusively, chemistry oriented.

When we talk about Artificial Intelligence, we often talk about Deep Learning, Machine Learning, our approach is different, we rather do analysis of textual data that we call NLP (Natural Language Processing or automated language processing), with a lot of statistical algorithms, which will be able to identify the entities and determine their relevance. – David Peyruc –

The project approach is to be able to identify what is relevant to clients in order to target the effectiveness of the results. Our algorithms, which are already powerful as standard, are configured to adapt to the needs of the users. It is in this sense that scientific know-how brings all its added value.

The collaboration between BASSETTI and DEXSTR is promising, while the new technologies of BIG DATA and Artificial Intelligence are democratizing, the synergies are constantly deepening in order to offer companies more and more innovative solutions that meet the needs of experts.

The two companies are already working on projects to offer other specialized modules such as advanced DNA sequence search.

Access to the official Bassetti communication

Previous publication from DEXSTR on Paperless Lab Academy^®:

How can you contribute to COVID-19 RESEARCH with Inquiro? 

Achieve Merger & Acquisition through Data Integration

How to provide relevant Search Results

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