Letizia Caccialupi, VP quality system excellence, and Dominika Lisikiewicz, head of global quality management systems and BPO at Aenova, explains why digital transformation in pharma starts long before the software.
Digital transformation has become something of a buzzword across pharmaceutical manufacturing, but introducing new technology is often the easiest part of the process. The real challenge lies not in technology itself, but in changing the way people work.
For manufacturers still relying on paper-based quality systems or a patchwork of legacy platforms, the appeal of digitalisation is clear. Standardised processes, improved data visibility and greater collaboration all promise to improve efficiency while supporting compliance. Yet as many organisations discover, technology alone does not deliver those benefits.
Instead, success depends on preparation. As Lisikiewicz said: "The devil's in the preparation." Before any software is implemented, organisations need to understand where their existing processes create the biggest challenges and where digitalisation will have the greatest impact. That means engaging with manufacturing sites, identifying pain points and prioritising processes that will benefit most from being digitised rather than simply replacing paper with software.
One of the biggest pitfalls, they argued, is expecting new technology to mirror existing ways of working. "The biggest mistake would be to go there unprepared and to pretend to change a company rather than changing your ways of working," Caccialupi explained, highlighting the importance of adapting processes instead of customising systems around historical practices.
For organisations operating multiple manufacturing sites, the challenge becomes even greater. Over time, individual facilities naturally develop their own processes and ways of working. While each site may be fully compliant, those differences can make it difficult to benchmark performance or share best practice across the wider organisation.
Deviation management provides a good example. If one site considers a deviation closed once an investigation is complete, while another only closes it after corrective and preventive actions (CAPAs) have been implemented, comparing performance becomes almost meaningless.
Creating consistent quality processes therefore becomes about far more than standardisation for its own sake. It establishes common definitions, improves the quality of operational data and allows organisations to compare performance more accurately across sites.
That does not mean removing all local flexibility.
Global manufacturers must still account for country-specific regulations and operational realities. Rather than enforcing rigid uniformity, successful programmes identify which elements genuinely need to remain local while standardising everything else. Importantly, the process can also challenge long-standing practices that may no longer be necessary.
As Lisikiewicz suggested, organisations should ask themselves: "Let's check if this is really a regulatory requirement, because maybe it's a historical thing that you do." Revisiting legacy processes through the lens of current regulations can often reveal opportunities to simplify workflows without compromising compliance.
Perhaps the greatest challenge, however, is not regulatory complexity but organisational culture.
Manufacturing sites are understandably proud of the systems they have built over many years, meaning change cannot simply be imposed from a central team. Instead, successful transformation depends on involving site representatives throughout the design process, tailoring communications to different audiences and giving employees opportunities to ask questions before implementation.
The speakers described this as bringing people along rather than forcing change upon them. "We really take them on a journey all the way," Lisikiewicz explained, ensuring employees become familiar with new processes long before go-live and continue learning through communities of practice once implementation is complete.
Another lesson from the project was the importance of maintaining focus. Digital transformation programmes naturally evolve as new ideas emerge, but allowing the scope to continually expand can quickly derail progress.
"We need to keep strong on the scope that we have established," Lisikiewicz said. "Sometimes it happens that we realise something is important for the site, but it is not in scope. We must be strong enough to tell the sites, 'No, we cannot do it now.'" Maintaining that discipline helps ensure projects remain achievable while preventing unnecessary complexity.
Looking ahead, many manufacturers see digital quality systems as laying the foundations for more advanced technologies, particularly artificial intelligence. However, AI is only as valuable as the data it analyses.
While discussions around digital transformation often focus on technology, this conversation highlighted a different reality. Successful transformation begins with preparation, collaboration and a willingness to rethink established ways of working.
The software may enable change, but it is people, processes and consistency that ultimately determine whether a digital transformation succeeds.