Facilitating Data Integrity & Compliance
- Broadcast #1: 12pm Singapore / 3pm Sydney
- Broadcast #2: 10am London / 11am Paris / 3.30pm Mumbai
- Broadcast #3: 12pm PDT / 2pm CDT / 3pm EDT
This expert presentation and discussion forum will focus on data integrity and compliance, particularly in the context of QA/QC, development, and manufacturing. Experts will highlight why technology companies need to put the customer at the heart of innovation, to ensure the development of solutions not just products. They will examine how different technology can offer benefits for regulatory compliance, with specific examples of how instrumentation, data integrity and compliance have been combined to provide effective solutions. The event will kick-off with the following presentation.
Technological Facilitation of Data Integrity Compliance
Data is the raw material of decisions and claims we make and, in modern society, the basis for being considered good practitioners on actions that others can observe. However, we have not acknowledged that we have been living in the postmodern world for many decades. Now, amidst and beyond the COVID-19 pandamonium, the economic plan is named “the Great Reset,” and “Build Back Better” is the political path forward. We must acknowledge that truth and reality are understood individually and influenced by personal reality, social belonging, gender preference, and culture, which is primed to cancel other realities. Hence, data integrity and truth will exponentially be assured in producing data electronically without human interference. While many parts of pharmaceutical processes and analytical equipment are certifiably compliant with CFR 21 part 11 requirements today, many gaps persist (e.g., mass spectrometers, NMR, IR, and their automation platforms. Historically developing 21 CFR part 11 compliant software has not been a priority for vendors, given that a tiny fraction of their customer base comes from the QC/GMP environment. Placing an added emphasis on the “totality of the evidence” in regulatory science is how we can fairly and responsibly (as per the FD&C Act) progress to mind and fill gaps. Let us make sense of an integrated approach to data integrity in the postmodern world.
Presenter: Ajaz Hussain (Independent Insights, Advice and Solutions for Science in Life)
