Digital Data Management discussions at the live edition of PLA2022Europe
The Paperless Lab Academy® 2022 Europe promises to be even more exciting than previous editions. More exciting definitely than last virtual ones as the human interaction component, all healthy measures observed, will bring us all back together. Hence, let’s keep on focusing on digital data management, but not digitally this time, but face-to-face!
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!
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