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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On our way back to Europe, we realise how powerful the experience of running our first edition of the Paperless Lab Academy® in India has been. In so many levels.

Not only because it is India and we, as Europeans, are overwhelmed by so many stimuli at the same time: sensationally spiced food, amazing scents, colours, and flowers adorning every corner, music, traffic rhythm, crowded streets, smiling faces…

Certainly, we were overwhelmed by the interest the industry showed in the Paperless Lab Academy®. The audience was literally glued to the speakers, panellists, workshop presentations and exhibitor’s booth, and wanted to get the most out of every session.

Milestones of a digital transformation journey

Right at the beginning of the program, our keynote speaker Sachin Bhandari, Sr. General Manager, Global Head QA-IT & Quality Digitisation Projects at Sun Pharma – generated a provocative discussion about the difference between digitalisation and digital transformation.

Digitalisation was basically described as the transition from paper to glass paper, i.e., the introduction of a digital interface for pure transactional operations. Yet without changing, most of the time, any upstream and downstream process, perhaps adding even more control steps and more printed copies (just in case).

In contrast, digital transformation requires strategy, focus on the big picture and alignment with the business requirements. It requires teamwork from all stakeholders, a willingness to embrace change, an open mind to adapt processes for greater efficiency, the agility and flexibility to adopt new technologies, and the knowledge and wisdom to comply with industry regulations without getting lost in the effort.

“The Paperless Lab Academy is a very exciting opportunity because the lab forms a very critical part of our entire quality gamut. In addition, a lot of organisations have different approaches towards achieving a paperless lab. If we look at my talk, for example, it’s about the milestones in achieving this kind of transition towards digital transformation and the paperless laboratory.”

Different organisations will be at different stages. “When you talk about the different milestones it’s not a turnkey approach, it’s a process”, comments Bhandari. “In my talk, I will consider the reasoning behind SunPharma’s decision to adopt digital technology. An organisation must consider the different steps or milestones that they need to achieve. That will help people to understand where they are, and the roadmap ahead.” Commented Mr. Bhandari during an interview with Rob Roe, editor at Europa Science Limited

The PLA2022India program continued with other great speakers: Manish Kumar, Head of Enterprise Architecture, Global Drug Development at Novartis, explained the strategy for building an Enterprise Data Lake and Neeru Bakshi, Founder of Tech Qualitas, demystified cloud-based solutions.

The topics covered during the live edition of PLA2022India have been so many, so insightful and inspiring that we will take them as precious input to write and publish articles on our blog in the coming weeks.

It is also thanks to this experience and to the warm Indian welcome that we could remember why this all started 10 years ago: a small forum somewhere in cold Northern Europe, moving to Barcelona, Spain, and then to Lake Maggiore, Italy, attracting more and more interest from visitors, sponsors and services companies, each time looking for bigger premises.
We founded the Paperless Lab Academy® in the firm belief that the industry was missing a learning platform where it could freely exchange ideas with peers, colleagues, experts and thought leaders. The feedback from the many visitors to #PLA2022India on how much they learned and how much they took home is once again overwhelming.

To stay within the scope of the topics covered in this issue, we can confirm that the Paperless Lab Academy® configuration has also been tested by multiple users and found to be good, operational, and functional, and thus validated.

In 2022 we landed in India with our first live Indian edition, and 2023 promises to be even more exciting: the 10^th edition of the European congress, the second edition of the Indian one and the very first edition in the USA are waiting for us, and we cannot wait to welcome you all there!

So…

We look forward to welcoming you to one of the three #PLA2023editions!

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The Paperless Lab Academy® offers Premium and Gold Sponsors the opportunity to present their solutions and services to the participants and to hold discussions on important topics with their experts.

These are the product deep dive Workshops that will be held at #PLA2022India on 23 and 24 November at the Novotel Hyderabad Convention Centre.

How to Achieve High Productivity and Compliance with a Robust LIMS

From Caliber Technologies you are invited to discover and discuss about their experience about digital transformation project in the labs.  When labs undertake digital transformation, they look for ROIs like compliance, efficiency, profitability, etc. A robust LIMS system can ensure that these ROIs are met effectively.

Rajasekhar Gollapinni, Head-Global Delivery has led the implementation of India’s First 100% Paperless Lab. He will discuss about how a LIMS helps in productivity and compliance, how to ensure that the lab is chasing the right ROIs, and how to make the best use of a LIMS.

Practical applications of Data Integrity and Audit Trail Review

From Lonza Informatics you are invited to learn and discuss about the why, what, when, where, who and how of audit trail review. Understanding your Audit trail and the ability to review the data contained in it is essential to compliance.

Karthic Sreenivasan, Manager Informatics, will discuss about regulatory requirements around audit trail review and he will share examples of audit trail review strategies. During this 1-hour workshop, Lonza will demystify the audit trail by providing recommendations and examples of good vs bad audit trails and providing tools to evaluate your systems for inspection readiness.

Digitalization: the Lab of the Future and Lab 4.0

From Labware you are invited to discuss about the trend of the future laboratories. The Lab of the Future, Lab 4.0, is the collective name for the technologies and processes that will enable the next generation of scientists and researchers. Mark Gonzalez, Technical Director will discuss about how technology will enable the transformation of Laboratory processes along with their challenges and strategies.

Pharma R&D to Manufacturing : Importance of Digital Continuity

From DS Biovia, you are invited to learn about how Dassault Systèmes helps research labs, process development Labs, CROs, CMOs and CDMOs achieve collaborative innovation and operational excellence through digital continuity.

Basha Kodidela, BIOVIA Senior Manager, Technical Sales, APAC will explain why going paperless requires of digital continuity.

A collaborative data management tool for chemical and biological therapeutics

From CDD, Collaborative Drug Discovery, you are invited to learn about why a standardized tool is very much in demand to manage the big dataset and share it with collaborators.

There is a growing need to securely integrate public data with private data. Dr Antima Gupta, application scientist will present their cloud-based data management tool Collaborative Drug Discovery (CDD) Vault that provides a more collaborative hosted informatics technology. New approaches that would allow scientists to do efficient research in order to handle registration of complex chemicals (stereochemistry, mixtures, synthetic conjugates) and biologicals (nucleotides, amino acids and complex drug-like biological entities i.e., Antibody drug conjugates, PROTAC, molecule Glue) as well as assay data around these entities, all can be covered using CDD Vault.

The paperless life sciences value chain

From Global Value Web, you should expect a session discussing about the paperless life sciences value chain. Where Global Value Web’s portfolio of managed data science service contribute to a paperless life sciences industry. As digitization partner along your digital transformation journey’s, in turn Global Value Web will make Indian life science companies’ better partners to the global pharma & biotech (& medical device) industry.

The digitalisation journey toward the Industry 4.0

From Sparta Systems, part of Honeywell, you should expect a session discussing about any progress made since the concept of industry 4.0 introduction 10 years ago, have we made it more complex in an effort to get rid of paper and why digitalisation is to be considered just the beginning of the journey.

Join the discussion, attend the workshops, and take time for further discussions with your colleagues, speakers and vendors in the exhibition hall.

Sponsors at the Paperless Lab Academy@ 2022 India

The laboratory informatics industry is one of the most comprehensive in terms of solutions offered around the world. During this 2-day congress, you will discover the wealth of the portfolio that this industry offers to laboratories

Whether you are a researcher aiming for creativity and innovation, a quality manager aiming for reproducibility and integrity, a lab manager aiming for efficiency and compliance, an operations manager aiming for business intelligence and data insight, or an IT partner aiming for consolidation, integration, and harmonisation, you will find the right people to talk to at the Paperless Lab Academy® Showcase.

 Don’t miss it – Register Now!

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After two virtual editions conducted for the Indian audience, the PLA is hosting the 3rd edition in India, now in person, on 23 and 24 November 2022 at the Novotel Hyderabad Convention Centre.

The two-day event, organised by NL42 Consulting, will bring together partners and participants in an environment designed to encourage mutual interaction and exchange of views during plenary sessions and theme-based workshops.

NL42 Consulting will partner with Eminence Business Media LLP for the first face-to-face edition in India.

Isabel Muñoz-Willery, co-owner of Paperless Lab Academy® and event director, said:

“With the support of Eminence Business Media LLP, we believe that the PLA’s successful formula will become a reference in the APAC region, sitting in Hyderabad, India. Eminence Business Media LLP has extensive knowledge and a large network in the manufacturing industry, as well as a strong reputation in event management. We are confident that this is the beginning of a promising journey for the PLA.”

 

About the Paperless Lab Academy®

The PLA is held annually and is aimed at directors and managers of research and development, IT, and quality departments in the pharmaceutical, cosmetics, biotechnology, consumer goods, food and beverage, petrochemical and chemical sectors. The event aims to provide the ideal learning platform for all organisations involved in running laboratories about the consolidation, integration, and management of the digital data they generate.

Registration and programme are available at www.paperlesslabacademy.com/PLA2022india

About NL42 Consulting

NL42 Consulting is a dynamic, free-thinking, independent management consultancy. Combining the flexibility and enthusiasm of a young company with the decades of experience of its owners, NL42 offers services that support the laboratory’s transition to paperless processes. The expertise the company offers is a powerful combination of technical know-how, in-depth management knowledge of laboratory workflows and international networking.

www.nl42.com 

contact: Isabel Muñoz-Willery Ph.D.

About Eminence Business Media

Eminence Business Media are the channel to connect the right set of people; the corporate bridge that connects knowledge, skills, and business under one roof. They conduct conferences, corporate-meetings, master-class trainings, seminars, events, and workshops, bringing expert speakers from across the world, personnel from superfluity of industries and service providers together and provide them content-rich and knowledge-packed sessions along with high level networking platforms. Their, simple but polished language effectively communicates the company’s offering while still allowing everyone to understand where they stand and where do they aim to be.

www.eminencemedia.in

Contact: Mr. Suryansh Rana

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The Paperless Lab Academy® is managed and organised by NL42 Consulting. NL42 is an independent consultant operating out of Europe and working as a consultant worldwide. The project was launched in 2013 and focuses on creating an ideal learning platform for anyone thinking about consolidating, integrating, and simplifying scientific data management systems.

In the 10 years that the European edition has been held, it has gained a good reputation thanks to its format, which is highly appreciated by participants and suppliers. The 3 magic ingredients are Plenary Session with Keynote speakers and Panel Discussions, numerous sponsored workshops in parallel sessions, Networking space in the agenda.

Plenary Session with Keynote speakers and Panel Discussions

The Paperless Lab Academy® like to focus on discussions about scientific digital data management, which in reality offer the opportunity to cover a wide range of topics.

For this reason, the plenary sessions always consist of keynote speakers such as global leaders of digital transformation projects, end users of specific tools, industry leaders and experts sharing their knowledge and experience.

Topics you´ll learn about at the #PLA2022India

• How to successfully implement laboratory system solutions
• Strategy for building the enterprise data lake successfully
• Future of the laboratory within the industry 4.0
• Demystification of the Cloud-based solutions
• Practical sessions on Audit trails, data integrity and new Compliance guides
• The impact of Data Quality
• More to come …

Panel Discussions

We are recovering from the pandemic situation where we all had too many virtual interactions and there were hardly any face-to-face events and meetings; the Paperless Lab Academy® would like to use such a forum to stimulate discussions, deepen a specific topic and let the audience interact directly and actively with the speakers.

Keynote speakers contributing to the Panel Discussions

Among the many advantages and key take aways you get out of the panel discussions, you’ll surely take home with you lessons learned from digitalisation projects and you’ll find out how to remain up to date with the technology and compliance.

Product Deep Dive Workshops

The Paperless Lab Academy® facilitates vendor interaction through multiple workshop sessions where subject matter experts propose solutions to key issues, present their latest solutions and share their expertise to support your specific needs.

The organization team has come up with a program full of insights and trend topics from the sector, for you to benefit and get the most out of the two-days event.

Networking with the Experts

The Paperless Lab Academy® is also a showcase space. In the exhibition hall, where all networking sessions are organised, you can enjoy healthy and intellectual nourishment by enjoying Novotel food and interact with the participants.

An excellent combination of well-known international suppliers in the laboratory informatics industry and new companies coming up with new innovative proposals. A true showcase space with world-class networking opportunities to gather deeper information with peers, colleagues, presenters, and vendors.

Free Registration for visitors

Participants who visit us each year include laboratory directors and managers, operational excellence, IT business partners, QC and QA management, research departments and manufacturers.

Industries that benefit significantly from the Paperless Lab Academy® Congress include: Pharmaceuticals, Laboratory Services, Biotechnology, Food and Beverage, Consumer Products, Cosmetics, Chemicals, Oil and Gas.

Participation in the conference is free of charge through registration for visitors.

Secure your place and request your free pass now!

The post Digitisation, Digitalisation, Transformation and Compliance: Discussions at the PLA2022 India appeared first on .

The pandemic effect on the urgency of digital transformation

The fact is that the pandemic situation has influenced, is influencing and will influence the pace of digitisation. The life sciences industry’s response to the pandemic has demonstrated a new urgency and ability to deliver life-saving vaccines at unprecedented speed.

New expectations for speed, agility and digital capabilities in labs have emerged across all industries, and there is no turning back.

The panel discussion proposed several polls to the audience to understand how companies have responded to the pandemic.

Feedback from the audience said that the pace of digitisation has increased mainly because of the many concerns raised by the pandemic. Successful leaders recognised the need to accelerate and scale lab digital transformation by driving digitisation across operations and processes, integrating efforts across labs.

Indeed, the overall laboratory informatics industry has seen an increase in sales, even if, surprisingly, the entire sales process has been handled remotely. In general, most projects were implemented appropriately, even though meetings such as kick-off, project review and training were again conducted remotely. On the one hand, the urgency was palpable, and the focus of the dedicated team was extreme.

Key drivers for the digital transformation of the lab

The panellists also wanted to know how the introduction of digital processes has improved productivity and collaboration and accelerated innovation. The following polls focused more on the difficulties of setting up a digital lab and the benefits that became apparent after the final implementation.

• What are the top 3 business drivers for your lab’s digital transformation?
• Where do you see the greatest benefit from digital lab processes?
• What are your 3 biggest obstacles to becoming a digital lab?

Interestingly, Accenture compared the results they published in their recent report. See full report and infographic:  Faster innovation: Driving digitalization in the lab.

The survey summarises feedback from 118 industry leaders from scientific laboratories on how companies are using digitisation to improve treatment development processes.

The immediate measurable impact of the pandemic is the figures showing that in 2019, 40% of companies had not yet deployed digital solutions, while in 2021, 91% were taking actions towards digitalisation. In 2019, 37% launched new digital projects, while in 2021 69% are piloting or even scaling up the adoption of digital solutions.

© Copyright 2022 Accenture 

Accenture’s report shows that those who have embraced digitisation see significant benefits in areas such as faster access to data, less manual effort, and better collaboration.

© Copyright 2022 Accenture 

The use of digital technologies in science labs increases productivity and collaboration for faster innovation. However, the barriers to building digital labs are usually internal, such as a lack of skills and talent, resting on change, and lack of a clear strategic vision matured by top management.

It goes without saying that the greatest impact of the pandemic is on people. Along with the fact that digital labs can only be successful if the technology is fully integrated into people’s routines and perfectly accepted. The companies surveyed also insisted that people play a crucial role in accelerating digital transformation. Thus, key skills and talents were cited as the 3 most important factors for digital transformation. The lack of specialised skills, such as Data Science, was cited as one of the top 3 barriers. All labs report the need to further train existing teams in areas such as Data Science and computational modelling.

Successful leaders have therefore recognised the need to implement a talent strategy that attracts and retains staff with the right skills.

The post Reflections on the Future of Digital in the Laboratory ( part II) appeared first on .

This Panel Discussion will be a nice exercise to assimilate all what’s been shared during the event, to reflect on the  future of digital in the laboratory and how the pandemic situation has, is and will influenced on the speed of digitalisation.

The life science industry responded to the pandemic with new urgency, delivering life-saving vaccines at unprecedented speed, scaling new diagnostics at population levels and leveraging digital innovations for resiliency in clinical trial delivery and for acceleration in research and development new therapeutics.

These breakthroughs have set new expectations for speed, agility, and digital enablement in labs across every industry, and it appears that there’s no looking back for any of us!

Reflections on the Paperless Lab Academy® 2022

We will hear throughout the conference how organisations and their scientific labs are looking to expand digital capabilities and transform productivity.

Successful leaders are realising the imperative to accelerate momentum and scale digital lab transformation, driving digital across operations and processes, integrating efforts across labs where possible, and executing on a talent strategy that will attract and retain people with the right skills.

In our review we shall take stock of the past and look to the future of the Digital Lab, summarising reflections on the speaker presentations, considering conference attendees responses to surveys throughout the event, and learning from the insights from the latest research in Driving digitalization at scale in the lab.

Our questions shall consider how we are addressing the foundational backlog of technical debt, the transformation imperative to drive change with data and insight from our laboratories, and our aspirations to truly reimagine our laboratories and businesses of the future.

We have seen how value has and shall be accelerated in the key areas of Operational Efficiency, Connectivity and Collaboration, Data and Insight and Human Experience in our business, exemplified by the passionate speakers throughout the Paperless Lab Academy® 2022.

Do not miss this very interesting last session that will certainly stimulate a good exercise of reflections and provide you good insights to bring back to your team.

Mark Fish, Managing Director in Accenture’s Scientific Informatics Services Business.

Mark has over 20 years of experience in various leadership roles delivering innovative solutions to the pharmaceutical sector and is passionate about drug discovery and development, translation research and precision medicine, digital transformation, agile software development and analytical quality control automation.

Peter Brandstetter, Senior Manager for Technology Consulting in Accenture in Zurich, Switzerland.

A respected authority in IT-enabled transformation in life sciences, he has more than two decades’ experience of solving complex IT challenges for pharmaceutical companies globally -gained across senior life sciences consulting/IT roles including Life Science Central Region Lead at CSC, Senior Managing Consultant for GBS Life Sciences at IBM, and Senior Manager at PwC.

Peter specializes in quality management and quality assurance in manufacturing and R&D, enterprise content management, and R&D (clinical data management, pre-clinical, R&D Lab, R&D collaboration and project management), as well as computer validation.

Jeremy Ward, Principal Director in Accenture’s Scientific Informatics Services Business.

Leader in Accenture’s Scientific Informatics Services practice in Europe with over 16 years experience in Scientific Informatics based in Base, CH and leading global client engagement and transformation. Jeremy specializes in working with organizations to transform their R&D, QA & QC digital and data management practices via risk management, process optimization and the implementation of innovative technologies.

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At the Paperless Lab Academy®, we’re determined to produce the best possible edition of PLA at the Lake Maggiore, Italy  for you at the end of April. Even if celebrating the 9th in-person edition, and we’ll be marking 10 years of global business, networking and collective learning.

Together with exhibitors, partners and speakers, we’re on a mission to build a show that helps sharing best practices for leveraging your laboratory and quality processes to support your company business.  One appointment at a time.

Sponsors, Exhibitors and Partners :

Our exhibitor hall is now completely booked. The support of our partners along the pandemic situation has been outstanding. Their trust in this edition is remarkable. The complete alphabet of laboratory informatics and digital data management systems, providers and consultant are signed up and ready to welcome you.

Presenters and Keynote Speakers:

The Plenary session program is full. With speakers from companies that like yours have started a digitalisation journey and willing to share their learn lessons, experience, the good and the bad… from Roche diagnostics, SGS, Lonza Visp, Eli Lilly, Alchemab Therapeutics, Carbogen Amcis, Dow Chemicals

Panel Discussions:

First one, focus is on Compliance! Mark Newton will drive a conversation on Data Integrity and Risk Management.

Mark is an independent consultant who specialises in data integrity, laboratory informatics, computer systems validation, and Quality. He has 35 years of experience in the pharmaceutical industry 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.
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”  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.

Second, best ever closing activity of the event with a Panel discussion chaired by Accenture, Reflections on the Paperless Lab Academy® 2022 : the future of digital in the laboratory

Networking Sessions:

the opportunities for interaction are multiple the Paperless Lab Academy® edition.  During the sponsored Workshops sessions, the long Coffee breaks at the exhibition Hall, the lunch sessions and the Cocktail Welcome on the first evening to relax after an intensive, exhaustive agenda with an assortment of best Italian food offering.

This is THE show to bring your global contacts list to life with vendors, consultants, speakers, peers and colleagues.

Visitors like you:

Join your peers and colleagues already registered. They come from everywhere around Europe, like you they are looking forward to get a sound grasp on the latest of the industry…

Registration is free for visitors. Put your name down today and keep your finger on the pulse

REGISTER NOW

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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

The post Advocating for FAIR plus Q to bring Data Quality and FAIR together appeared first on .

Wega Informatik, based Switzerland and in Germany, with more than 80 employees nowadays, is the preferred partner of IT and business departments to support their R&D and QC projects. They provide specialised services in the Life Science, Pharma and Healthcare industry, combining business, process and informatics knowledge: “Building the bridge between business and IT”

As such, they offer in-depth expertise in various areas, through the tight collaboration between their 4 dedicated  groups:

• Clinical Development IT
• Lab & Research IT
• CSV & QA
• IT Solutions

Wega Informatik has been sponsoring and supporting the Paperless Lab Academy® for years. Lately, always as Premium sponsor. In this pandemic time, Wega also has shown great support to the PLA initiatives and with remarkable collaborative attitude accepted the challenge to run 3 sessions at  the PLA2021 Europe virtual edition (see WEGA goes Live at the #PLA2021Europe.)

At the PLA2022 Europe, Daniel Juchli, Head of Lab & Research Informatics will be leading their workshop about user centric lab digitalisation. Daniel will develop on how to bring real value to the lab through flawless integration strategy. He’ll explain how data “automagically” follows you while working in the lab, in a non-invasive way. Data is transferred between instruments, ELN or LIMS but this does not require a big IT project or infrastructure.

Wega Informatik: Agile Validation

Wega Informatik: Audit and Inspection Support

The post Wega Informatik: Focus on our Premium Sponsor at the Paperless Lab Academy® 2022 Europe appeared first on .