The State of Play
With the pharmaceutical industry in the midst of a digital transformation, a recent survey conducted by the PDA (the Parenteral Drug Association) reveals a telling picture of where companies are on their journey. Respondents were asked to rank their company’s level of digitalization on a scale from 1, meaning minimal digitalization, with predominantly paper-based processes, to 5, indicating advanced digital integration with optimized processes and advanced data utilization. The results highlight a spectrum of maturity.
Unsurprisingly, while many organizations embrace digitalization, 79% of them are, at most, in the middle stages of adoption, with only a tiny percentage achieving advanced maturity.
Notably, the survey reflects digitalization at the company level. However, based on our experience, analyzing digitalization at the site level would likely show results skewed further towards the lower end of digitalization. Large companies with multiple sites often prioritize digital transformation at a select few, leaving many other sites operating with little to no digitization. This discrepancy underscores the uneven progress in achieving full-scale digital integration.
With regulatory frameworks like Annex 1 pushing for enhanced data integrity and efficiency in sterile manufacturing, the need for smarter digital solutions is more pressing than ever. The PDA survey results highlight an industry ready for change but struggling with the “how.”
Moving Beyond ‘Moderate’
The prominence of "moderate digital integration" as the top response points to a significant opportunity—and challenge—for the industry. Moderate adoption often means that digital tools are in place but are not fully optimized or integrated into workflows. This can create inefficiencies and limit the transformative power of digitalization.
Meanwhile, the low ranking for "advanced digital integration" underscores the barriers that pharma companies face:
- Regulatory Complexity: Achieving compliance with GxP standards while adopting advanced digital systems can be daunting.
- Data Utilization: Many companies collect data but lack the systems to transform it into actionable insights, particularly through the industrialization of AI.
- Cost and Time: The perception of digital transformation as a high-cost, long-term investment often delays implementation.
iBR: A Smarter Path Forward
The PDA survey highlights the need for solutions that accelerate and democratize the adoption of digital systems. This is where Aizon Execute, as an Intelligent Batch Record (iBR) solution, excels.
With its rapid implementation and validation, Execute dramatically lowers the barrier to entry, enabling companies to start seeing results in just six weeks. This crucial ease of deployment makes it easier than ever for companies to shift the paradigm towards data-driven manufacturing and benefit from true paperless processes, review by exception, and the myriad advantages of digitizing and centralizing your manufacturing data.
Beyond accessibility, Aizon Execute empowers organizations with actionable insights to reduce deviations, accelerate batch reviews, and optimize compliance. By focusing on batch record digitalization, it delivers immediate value and sets the stage for Pharma 4.0 readiness—without the prohibitive costs or timelines of traditional systems.
Strategic Flexibility for Pharma Manufacturers
Aizon Execute is not only a powerful standalone solution—it’s also highly versatile, offering strategic flexibility to meet the diverse needs of pharma manufacturers:
- As a primary iBR: Execute can serve as the company’s Intelligent Batch Record solution for comprehensive, paperless batch management.
- For resource-constrained sites: It’s an ideal fit to extend digital operations to those sites that cannot afford the cost, complexity, rigidity, or extended timelines associated with a full MES deployment.
- As a bridge to an MES: Execute serves as a temporary yet transformative solution for companies awaiting the implementation of their chosen MES system. By generating data, improving processes, and driving efficiency within just six weeks, it provides immediate value. Once the MES is in place, companies have the choice to either adopt their MES eBR or keep Execute as their iBR for long-term use -with the difference of having years of process data and process improvements on their back.
This flexibility ensures that Aizon Execute meets companies wherever they are in their digital transformation journey, providing scalable, practical solutions that address real-world challenges now, not ten years from now.
Charting the Path Forward
The PDA survey reveals a pharmaceutical industry in transition, where digital maturity varies significantly across organizations. With a majority of companies reporting moderate levels of digital integration, the survey underscores a clear gap in achieving high digital maturity and advanced data utilization. These findings highlight both the opportunity and the challenge: the need for solutions that not only accelerate digital adoption but also deliver measurable value quickly and efficiently.
As the industry continues to gradually embrace Pharma 4.0 principles, solutions like Aizon Execute offer a way to bridge the digitalization gap, helping organizations unlock the full power of their manufacturing data and move closer to true operational excellence.
