The pharmaceutical industry is navigating a crucial juncture in its journey toward digital transformation. To better understand the challenges and opportunities in this process, the Parenteral Drug Association (PDA) has once more conducted its Pharma Digitalization Landscape Survey as part of its Drug Manufacturing Digitalization Roadmap Committee initiative. This survey aims to assess the current state of digitalization in pharmaceutical manufacturing, identify key barriers, and highlight areas with the greatest potential for improvement.

In our previous article, we explored how respondents rated their organization’s level of digitalization. In this piece, we focus on what respondents identified as their organization’s primary challenge in adopting digital technologies within pharmaceutical manufacturing processes.

The Top Challenges in Digitalization Adoption

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When pharmaceutical companies were asked to identify their biggest hurdles, they cited the following challenges:

Budget Constraints for Implementing Digital Initiatives
Financial limitations were the most frequently reported barrier. Many organizations, particularly smaller ones, struggle to allocate the resources needed for comprehensive digital adoption.

One of the reasons for this is that, while the savings generated by digitalization can outweigh the initial investment, the upfront costs often make companies hesitant to move forward.

This hesitation is further compounded by the long time-to-value of certain digital solutions. Extended implementation times delay the realization of benefits, putting additional strain on budgets and resources. Moreover, the true total cost of ownership (TCO) frequently surpasses initial estimates due to hidden costs beyond licensing fees. For instance, many electronic batch record (eBR) systems require specialized teams to program and maintain manufacturing recipes, and hardware maintenance costs, security measures, and the ongoing need for power and cooling infrastructure can further escalate expenses.

Concerns About Data Security and Compliance
Compliance with GxP and other regulatory requirements remains a pressing concern. Organizations are wary of adopting digital tools that may pose data security risks or lead to non-compliance. Furthermore, recipes, which are among the most valuable intellectual property assets in pharmaceutical manufacturing, must be safeguarded.

In many cases, the lack of a strong data culture also leads to a reluctance to share data, stemming from concerns about uncovering inefficiencies in past practices or demonstrations that processes can be improved.

Digital and Data Science Literacy; Lack of Strong Data Culture
Building internal expertise and fostering a strong data culture are critical but challenging steps for organizations aiming to succeed in their digitalization efforts. While the experience of personnel is invaluable, when augmented with data, it becomes much more robust. Data-driven manufacturing insights can elevate traditional methods, enabling more precise, efficient, and optimized processes.

Resistance to Change Among Employees
Employee resistance to change, often fueled by uncertainty about how digitalization will impact roles or disrupt familiar workflows, was another significant barrier.

For operators, this resistance is often rooted in the need to adapt to radically different ways of working, which include increased surveillance and traceability. This heightened visibility can create a sense of added pressure and accountability, further intensifying reluctance to embrace new systems.

Lack of Awareness About Available Digital Solutions
Some organizations reported limited knowledge of existing digital tools that could meet their operational needs cost-effectively.

However, it is worth noting that this factor was perceived as the least influential overall, suggesting that most respondents believe they are aware of the available solutions but lack the financial or resource capacity to invest in them.

Additionally, the inability of suppliers to adequately support the implementation and maintenance of digital systems also emerged as a challenge.

While these challenges may seem daunting, they represent opportunities for companies like Aizon to lead the way with solutions designed specifically to address the needs of GxP manufacturers.

How Aizon Lowers These Barriers to Maximize Time-to-Value

As an organization devoted to intelligent GxP manufacturing, Aizon has an important role to play in addressing these challenges and offering pharmaceutical companies a practical and efficient path to digital transformation. Here’s how Aizon tackles the challenges cited in the survey:

• Budget Constraints for Digital Initiatives: A lightweight and modular solution like Aizon Execute sets a new standard for efficiency, with implementation and validation completed in as little as six weeks, requiring minimal time and effort from the client’s side. This speed translates to a fast ROI, putting it years—sometimes even decades—ahead of traditional solutions. This makes digital transformation achievable for companies of all sizes.
• Concerns About Data Security and Compliance: As a pharma company specializing in technology rather than the other way around, Aizon ensures that compliance is built into every aspect of its tools. Designed to meet GxP standards and incorporating robust cybersecurity measures, Aizon’s solutions give manufacturers the confidence to embrace digitalization while maintaining stringent compliance.
• Addressing the Skills Gap: Designed with ease of use in mind, Aizon’s solutions are intuitive and minimize the need for specialized expertise. Their user-friendly interface eliminates a steep learning curve, allowing existing teams to quickly adapt without the need for external hires, thus reducing barriers to adoption. For example, the digitized prescriptions closely replicate the look and feel of the traditional paper version, making the transition for operators seamless and straightforward. Additionally, Aizon democratizes recipe programming, enabling any employee to master it with just six hours of training.

• Resistance to Change Among Employees: Aizon Execute is built with user-friendliness at its core, ensuring seamless integration into existing workflows without requiring complex adjustments. Its rapid implementation and intuitive, time-saving functionalities make it a solution that plant operators can adopt in as little as a single day, reducing resistance and fostering smooth transitions to digital operations.
• Delivering Comprehensive Supplier Support: Aizon offers end-to-end support throughout the entire implementation process and beyond. From smooth onboarding to rapid issue resolution and ongoing system updates, Aizon ensures clients are equipped to maximize performance and meet their digitalization goals. Additionally, through Aizon Consulting Services, the company offers hands-on involvement in everything from process optimization to root cause analysis. With over a decade of experience in GxP AI, Aizon brings a deep understanding of the regulatory and operational complexities in the life sciences sector, ensuring that all solutions are designed with compliance and industry best practices in mind.

The Road Ahead

The barriers to digitalization highlighted in the PDA survey are significant challenges for the pharmaceutical industry. However, these obstacles should not hinder progress. As the industry continues to evolve, Aizon remains committed to helping companies navigate the path to digital success, making it easier for them to harness the power of modern digital tools and embrace the future of manufacturing.

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