As Asia’s top financial hub and one of the top five busiest shipping ports in the world, Singapore is also one of Asia’s most modern. Recognized for its focus on strategic urban planning and renovation, innovative architecture, green sustainable initiatives, cultural diversity and high living standards, Singapore is a business-friendly city of high aspirations and vision, and it was the perfect backdrop for the 2023 PDA Manufacturing and Quality Conference. Held the 8th to 9th of August, the conference was filled with presentations and panels that provided insights in how robotics, automation, digital twins, artificial intelligence, and machine-learning technologies are now being leveraged to create and demonstrate what will become new paradigm-shifting value within our industry. The conference also focused on the industry’s top challenges, including how to revolutionize the Quality Unit, manage the development, scale-up, and manufacturing of biologics, leverage mRNA platforms, and ensure that companies are achieving the needed levels of data governance and integrity, which are necessary to ensure that new technologies not only meet the quickly evolving compliance expectations, but that the volumes of data these technologies both generate and consume also have the appropriate quality needed to ensure the quality of future therapies, to support believable and trustable quality insights, and to drive business differentiation and new market value.
The intertwining of topics at the conference clearly highlighted that a successful digitization journey requires that companies adopt specific technology-driven data strategies within each area of the value chain and complement/underpin these with multi-dimensional modernization and adoption programs that focus on people, processes, systems, quality, and culture.
Our discussions focused on the significant and rapid changes in expectations for data integrity and governance for both sterile and non-sterile manufacturing. The traditional concepts of data integrity have been replaced by more holistic concepts of end-to-end data governance. Expectations are being applied to all GxP data across the value chain and far beyond the traditional quality-control laboratory focus. Regulatory bodies are issuing broad citations for lack of data governance and assurance of integrity of data. The most successful companies and leaders will ensure data integrity “by design” by building holistic, sustainable, and demonstratable data governance throughout their businesses and as a fundamental design objective within their automation and digitization projects.
As the industry continues to adopt new digital technologies, the pace of growth of our data mimics the global phenomena where the volume of data is now over 79 zettabytes (a trillion gigabytes) and on pace to double every few years. With this explosion of data, now, more than ever, it will be essential for companies to build strong, efficient, and sustainable data governance cultures and controls. The successful companies of the future will have implemented strong programs of “data integrity by design.” And to ensure the efficiency and sustainability of these programs, they will have leveraged the power of new digital technologies not only to discover and deliver our future medicines, but also to achieve and demonstrate the necessary data integrity that will underpin how they demonstrate the quality and safety of their medicines.
A Note on Data Integrity Services from Lachman Consultants
The traditional, narrow focus and interpretation of data integrity on the computer system, the laboratory, and intentional falsification of records has rapidly evolved and, today, data integrity expectations are looked at more broadly towards managing vulnerabilities and risk across a company’s operations and for all GxP data. Agencies are making these modern compliance expectations clear in manufacturing, distribution, facilities, third-party and post-market areas. Is your company ahead of the data integrity wave? Are your facilities prepared for the next agency inspection? Call or message Lachman Consultants today at LCS@lachmanconsultants.com to explore how you can take your data integrity to the next level.
