Quality by Design (QbD) & Paperless Lab Consultancy
Making Informatics Work Across Your Teams
Publications

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International




Roadmap to Digital Convergence
Laboratory Informatics Guide (LIG2017) / Scientific Computing World by Peter Boogaard

Data intensive science is becoming mainstream, and new technology will change the dynamics of how scientists will work together. Healthcare, banking and the consumer industry have all adopted paperless and electronic data integration approaches, which means that many technologies are now mainstream and available at our disposal. Many cross-industry best practices can be used to enable cross-functional collaboration between internal information silos to transform scientific information into actionable insights.

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Trends In Laboratory Informatics
GMP Journal / Concept Heidelberg by Peter Boogaard

Just like almost anywhere else, informatics is the normality in lab operations. Data intensive analytics create gap-less knowledge management systems also facilitating the cross-sectoral collaboration. The trends in data integrity, security and in the current regulatory requirements were in the centre of interest during the lab informatics updates at the PharmaLab Congresses of the last two years.

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How Good Is Your Data
Pharmaceutical Engineering - Special Report DATA INTEGRITY - Contribution Peter Boogaard

Data integrity is currently one of the highest cited areas in regulatory observations. Yet, data integrity is not a new requirement. Data-intensive science is becoming far more mainstream in our daily laboratory operations. The laboratory is a strategic provider of scientific evidence to support daily manufacturing and research operations in almost all pharmaceutical operations (Page 53+).

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How to Improve Data Integrity
Laboratory Informatics Guide (LIG 2016) / Scientific Computing World by Peter Boogaard


Data integrity is currently one of the highest cited areas in regulatory observations. Yet, data integrity is not a new requirement. In this article I will highlight the ways in which organisations, to their own benefit, can reduce data integrity inconsistencies within their operations. Before zooming in on the details, however, we need to set a baseline to ensure we have a common understanding.

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Linking an Instrument to a tablet is still a bridge too far?
Scientific Computing by Peter Boogaard

For how long do we need to be professor to link an instrument to a tablet in the laboratory? Why can we connect almost any smartphone using bluetooth in our personal lives ourselves and why do we need a professor to transfer simple results in the laboratory to our ELN, LES or LIMS? Atrium research rated this article excellent!

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The Paperless Laboratory: A Way Into Process Optimisation
BioPharma Asia by Peter Boogaard

In this article, I will share experiences and observations how the scientific high-tech community, can benefit from adopting paperless processes in the laboratory. Is it because paper doesn’t require any significant investment budget, or is it the low barrier to access, since paper even works without power or the need to have access to an information infrastructure, or is it just simply that the “what’s in it for me” question hasn’t been answered satisfactorily for the scientists?

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Managing change in the laboratory to deliver more value

Laboratory Informatics Guide (LIG 2015) / Scientific Computing World by Peter Boogaard


New scientific data consumers are increasing the value of laboratory. Managing change in the laboratory to deliver more value. Many research, manufacturing and regulatory procedures have been unchanged for years. There is an urgency to revisit these. The need to integrate the legacy silo based departments is becoming a top priority agenda item in many boardrooms.

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2015 promises major Milestones and demand for Change in Laboratory Automation
Scientific Computing by Peter Boogaard

In 2015, the adoption of new technologies is expected to have a significant impact. Data integrity is a big concern. Managing operating budgets will be redefined in the next decade. Technology will be critical, but our ability to change our mind-set to adopt to these changes will be the real challenge. Are we ready to make a start in 2015?

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The Data Management Paradigm

Business review Webinars


How Integration of Data Will Revolutionise the Scientific Industry Data
. Replay webinar
 





Is LIMS outdated?

Food Lab International

During the Utrecht-based LabAutomation in June 2014, eFOOD-Lab International discussed the future of LIMS, Electronic Lab Notebook ELN and other features with Peter J. Boogaard

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Scientific Computing World - Paperless Lab Academy by Tom Wilkie

Tom Wilkie, chief editor of Scientific computing World finds out what makes Paperless Lab Acabdemy distinctive, which was organized by Industrial Lab Automation
.

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Joining Up The Laboratory

Laboratory Informatics Guide (LIG 2014) / Scientific Computing World by Peter Boogaard


It is pure waste to perform labour-intensive hunting for information across multi-vendor, multi-technique databases, manual transcription checking and to manually create reports. Many laboratory integration projects are under pressure to deliver upon their expectations, as defined at initial start during the kick-off of. What are these challenges to create value for the consumers of the laboratory data? So why is it, that laboratory integration is so difficult in the overall process?

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Adopting a Self-Documenting Paperless Mind-set
Scientific Computing - by Peter Boogaard

The power of a Paperless Laboratory is the ability to enable organizations to implement self-documenting processes that produces GxP-compliant documentation which eliminates unnecessary tasks from the workflow, to result in a significant cost of non-compliance to support corporate Cost of Goods Sold (COGS) optimization. Will this require a fundamental mind-set change?


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Is less more in a paperless laboratory?
Scientific Computing World by Peter Boogaard

Many congresses and seminars are highlighting technologies, software from a technical functional perspective. The paperless Lab forum has a different angle. Instead of thinking in just products and services roadmaps, the tone was set to first define why and what you want to establish within your organization. What are the overall business objectives before talking about solutions? Is it a process improvement to achieve better quality? Or to lower the cost of operation? The ability to expand your analytical throughput?

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When data comes together
Laboratory Informatics Guide (LIG 2013) / Scientific Computing World by Peter Boogaard

The laboratory informatics landscape is changing, and a few changes have been made to the 2013 edition of the scientific computing world annual Laboratory Informatics Guide. When considering data integration, we must first stop thinking ‘technology’. Integration is not just about instruments or other software platforms. Instead, it is about integrating processes, accelerating ideas and facilitating mandatory compliance requirements more economically.

  • Data integration is not a goal on itself. How to set expectations and goals
  • First things first - Importance of data standards
  • Context is king - Importance of managing meta data
  • Collaboration - Data intensive science is becoming mainstream. Here is why.
  • Cheating is allowed - importance of adopting cross industry data integration practices

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Facing Cross Industry Challenges in the Food and pharma Industries
Scientific Computing by Peter Boogaard


Food companies are becoming pharma companies. Pharma-foods, the intersection between food and pharmaceuticals, represent an area of growing opportunities for the food sector. Developing pro-active approach adapting QbD as a standard model and implementing new tools such as PAT, KQI and CQA  will leverage learning’s from both industries. Agile processes integrating “intelligent Equipment” will result in a new system-landscape allowing a seamless dataflow from start-to-end.
  • The mindset and human factor critical to adopt best practices in both industries
  • Cross-industry learnings including deployment of PAT and QbD/6 sigma
  • The changing role of the consumer interaction and how it may become part of the product life cycle

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The Scientist Is No Longer In The Laboratory, But Integrated In The Overall
Quality Process

Business Review Webinars -  by Peter Boogaard

Economic Pressures to Reduce Effort on Compliance and Improve Quality have accelerated the Adoption of Quality by Design and PAT in pharma. This webcast will give viewpoints if QbD is here to stay, the future of PAT in pharma and how paperless processes improve self-documenting processes. Includes the results of QbD, PAT and Paperless processes poll.

  • Introduction to QbD concept and update on ICH Q10 and QbD Pharmaceutical Quality Systems guideline
  • Overview of PAT technologies and industry examples in both development and manufacturing
  • Introductory overview of Product Quality Lifecycle Implementation (PQLI) and Introduction to the 4 Product Quality System elements (PQS)
  • Introduction to paperless lab initiative, to help you eliminate the informatics information silo’s and create self documenting processes

Download the presentation  Download QbD white paper  View Poll Results



 

Building a Smart Laboratory

Scientific Computer World by John Trigg, Peter Boogaard and Bob McDowall


Building a Smart Laboratory is a new publication from Scientific Computing World. It is designed to provide an introduction to the concept of the integrated lab, giving newcomers and all the background they need to make informed purchasing decisions.

Topics covered




 

The Glue to Build Enterprise Knowledge

Scientific Computing by Peter Boogaard


It is time to put more emphasis on the preventing facet and re-order the sequence of the CAPA abbreviation into PACA. We now can turn our potential data graveyards into valuable resources to facilitate the QbD promise across the pharmaceutical Quality System model. It is proven that his theory to adopt continuous improvement strategies to decrease variability resulted in significantly better products and financial performance.

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Informatics engine drives toward Quality by Design
Scientific Computing by Peter Boogaard & Hans Griep


For years, other industries, including the automobile, aviation and food & beverage industries, have adopted, very successfully, the Six Sigma QbD philosophy. ICH rolled out its first framework for a QbD concept for Pharmaceutical Development in 2003. Will informatics drives Pharma development towards Quality by Design? Knowledge management is a key enabler to adopt the ICH Q10 model. An introduction how informatics will drive Pharma development towards Quality by Design.


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ELN means many things to many People
GIT Verlag by Peter Boogaard & Patrick Pijanowski (
LabAnswer)

ELNs mean many things to many people. This article starts with the end user in mind and look at the application from a user-centric perspective.  What is an Electronic Laboratory Notebook (ELN)? What function does it serve? Where does it fit within my laboratory informatics strategy? Do we need an ELN, and if so what would be best for my company’s needs? When should I use an ELN, or a LIMS or both? 


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Latest weather forecast: more clouds on the horizon
Drug Discovery World by Peter Boogaard


Latest weather forecast: More clouds on the horizon. Cloud Collaboration has allowed projects of previously unimaginable scale and scope to be constructed at an unmet price/performance ratio. Widespread access to Information and Communication Technologies (ICT’s) and agile, adaptable systems of workflow now allow people across the globe to collaborate on virtual mega-engineering projects that are unprecedented in scale or scope. Read more how CaaS is crossing the chasm in Drug Discovery World.


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Considerations for software expansions and upgrades
Scientific Computing by Peter Boogaard


Headaches about upgrading your software? Considerations for software expansions and upgrades. Before you decide to rock the boat, several key decision-making steps can help to ensure a smooth and successful upgrade. The last thing to do is to start is a project to change a working enterprise application environment.... 


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Begin with the end in mind
Scientific Computing World by Peter Boogaard

Digital explosion changes the laboratory. Has the digital normalisation entered your laboratory, or are you still waiting?


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