iSpeak Blog

The Future of Information Systems in a COVID-19 Pharma Industry Era

Christian Woelbeling
Robert Dillman
The Future of Information Systems in a COVID-19 Pharma Industry Era

This year’s 2020 ISPE Annual Meeting & Expo is going virtual and the importance of Information Systems for our industry is getting very obvious even now to everybody in the organization. The ISPE’s Pharma 4.0™ Operating Model is showing that the Covid-19 has a heavy impact on the cultural element of the model already, as digitalization is enabling us to work remotely and to enable business continuity.

Pharma has approached operational excellence with close care and constructive humbleness, accepting the debate with the rest of the industrial world. This has allowed pharma to pragmatically and eventually realize that operational excellence is the attitude and culture for constant change and the best environment to sustain continuous discontinuity, which is what it takes now to cope with the Pharma 4.0™ changes, creating further value from them.

A culture for change, the data integrity principles and techniques, a determined attitude, and a route supported by evolving regulations are the basis of building pragmatic principles for a to-be information process in pharma R&D and manufacturing.

In short, two main elements deserve a mention:

  • Vertical integration of the information from the physical process up to the business management
  • Increasingly leaner and integrated exchange of information with the Regulation Authorities

It is more than a trend, it is the practical experience made by many parts, and a precise perspective for the near future.

From this newly conceived vertical integration, in a frame of full control of our newly organized information, we can look with confidence to the challenges of the new pharma supply chain, which faces a complex reality where demand and relationships are changing. Hence the role of Pharma 4.0™ technology and attitude gets central to provide near-real-time data visibility, to support the end-to-end process collaboration, to enable new models, and a new potential, which has been inaccessible so far.

The Information Systems Track will have focused Sessions around the ISPE Pharma 4.0™ Operating Model Elements and GAMP® supported foundation. As GAMP® is since decades ahead in automation concepts, Data Integrity by Design as a foundation in the ISPE Pharma 4.0™ Operating Model is represented in 2 Sessions to introduce the approach of the new GAMP® Data Integrity by Design Good Practice Guide!

Data Integrity by Design is a critical-to-quality initiative for GxP organizations because their business model is driving changes in technology requirements. That is to say, the globalization of business needs the ability to manage data globally. Additionally, there is an urgent need for fully electronic records replacing manual tasks to eliminate process steps that are potentially subject to human error and therefore comprise points of higher data integrity risk. With continued outsourcing there is also a significant need to manage the integrity of the vendor’s data that could affect the parent company’s products. In addition, with the large volume of data being generated there need to be metrics and business rules to detect potential issues to control the integrity of the data in order to meet regulatory expectations Challenges for GAMP® in Cloud/AI/ML/CyberSecurity.

Additionally, the GAMP® Blockchain initiative is represented to showcase the importance of secure track & trace technologies for a variety of applications. The security aspects of a digitalized working environment is often underestimated. As an innovative technology in the pharma world today, Machine Learning (ML) is an increasingly used form of Artificial Intelligence (AI). However the key difference in Machine Learning is the volume of data which is required in order for such technology to be successful. In do so, and requiring such, the integrity of this data is of paramount importance.

As pharma and biotech look to implement Pharma 4.0™ technologies to improve their manufacturing operations, there is trepidation about whether artificial intelligence (AI) algorithms are acceptable for use by regulatory agencies. A few years ago, the European Pharmacopeia promoted two AI algorithms (neural networks and support vector machines) as valid chemometric methods yet little has been done to make a difference. There is an immense amount of research behind it and provides a standard methodology to qualify AI algorithms using the Design of Experiments (DoE) methodology and shows how they are safe to use, even encouraged, by regulatory bodies and auditors. A novel approach to qualifying AI algorithms for use in validated applications, including direct dialogue and feedback from FDA Emerging Technology Team (ETT), will be discussed. This approach will accelerate AI implementation in the pharmaceutical industry.

Having a background in life science and a SaaS LMS used in that industry; most life science companies do not understand how to implement cloud systems (SaaS), especially how they differ from traditional IT model and the vendor assessments as to 2017 2017 Q&A addendum to 21 CFR Part 11 (Clinical Investigations). Strategies and pitfalls will help with SaaS implementations.

Pharma 4.0™ is also coming with Quality 4.0, the next step in supporting the ICH Q10 Pharmaceutical Quality System. The Quality 4.0 session will explain how digitalization is influencing today’s daily business especially for the Quality Organization with its operations.

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