Reflecting on a conference from seven years ago, I recall a speaker discussing the transformative potential of Industry 4.0 in pharmaceutical manufacturing, coining the term “Pharma 4.0.” The room buzzed with concepts like the Internet of Things (IoT), big data, and artificial intelligence. One particularly striking image was of a “lights-out” factory, where manufacturing processes operated in complete darkness, illuminated only by a few indicator lights. It was a breathtaking vision!

After the conference, I debated with a QA colleague whether quality assurance personnel might be replaced, similar to manufacturing operators. I confidently asserted that human judgment and critical thinking were irreplaceable. Evaluating changes, assessing risks, investigating deviations, and managing Corrective and Preventive Actions (CAPA) are complex processes that require human insight. I believed that while systems could assist in managing these processes, the core analysis and decisions would always rely on people.

Looking back, I realize my perspective was overly simplistic. I once viewed AI as complex programming bound by predefined instructions. However, with the advent of ChatGPT in 2022, I recognized AI’s remarkable learning capabilities. Given the right database, AI can search, analyze, and synthesize information, potentially producing quality investigation reports akin to those generated by QA professionals.

At Bora Biologics, we are at the forefront of integrating AI-driven quality management systems tailored specifically for the pharmaceutical industry. This evolution suggests that QA personnel involved in deviation investigations and report writing may gradually be assisted by AI tools, enhancing our efficiency and accuracy. Should I consider a career shift? Not at all. I view this challenge as an opportunity.

Even as AI generates reports, a human touch remains essential. Accountability for conclusions and decisions cannot rest with computer systems or developers. Every investigation result and proposed CAPA must be reviewed, approved, and ultimately owned by a qualified individual at Bora Biologics, ensuring that our commitment to quality and compliance is upheld.

What will change is the traditional approach to our work. The future lies in learning to leverage AI management systems effectively, enhancing our interaction and communication with these advanced tools. By adopting this innovative approach, we can conduct deviation investigations and CAPA more efficiently, ensuring that Bora Biologics continues to set the standard for quality assurance in the biopharmaceutical industry.

About the Author

Matthew Ding brings over 16 years of experience in GMP quality and compliance management to his role as Sr. Supervisor of Quality Assurance at Bora Biologics. Holding a Master’s degree, Matthew spent 6 years as a GMP inspector at the Taiwan Food and Drug Administration (TFDA) and has over a decade in the pharmaceutical industry. In his current position, he is responsible for conducting internal and supplier audits, as well as coordinating external audits performed by Qualified Persons (QPs) and clients. Matthew’s extensive background in quality assurance underscores his commitment to maintaining the highest standards of quality and compliance, which is essential to Bora Biologics’ mission of advancing biopharmaceutical innovations.