How Digitalization and New Regulations are Reshaping Commissioning & Qualification

One of the most fundamental concepts that came with modern qualification is "Right First Time," an idea that emphasizes the importance of completing qualification activities from the word go by clearly defining requirements, outlining risks, and establishing consistent protocols to avoid the need for corrections later. What this means in practice is that instead of waiting to complete all the steps and then revisiting each one of them later on, each step must be done correctly before moving on to the next phase. If you are someone who has worked on large C&Q projects, you know how duplication, unclear requirements, and documentation can impact your work and take a toll on resources and timelines. With proper documentation flows that are consistent and properly structured, most issues like these simply disappear, and this is why we should think of "Right First Time" as more than just a slogan. 

Despite their importance to sterile manufacturing, QC laboratories, or biotechnology plants, environmental conditions were often handled separately from the main qualification effort. Today, however, with environmental qualification, these conditions are being integrated into the same lifecycle approach and managed as part of the broader qualification and operational framework of the facility. The same applies to periodic requalification, which is no longer treated as a simple recurring task but as part of a structured, continuous process aligned with how facilities are designed, monitored, and operated.

Looking back, we have made important strides toward digitization and alignment with Pharma 4.0; nevertheless, this does not mean progress is even throughout the industry. According to 2024 data, about 36% of companies are still at an early stage of digital transformation, 24% are already implementing more advanced technologies, and only 4% have reached full digital integration (2;3). This ongoing transformation, the gaps discovered during these studies, and the technology we are using, which is constantly evolving, remind us of the critical role experienced consultants play in supporting the industry with regulatory shifts and demands. This includes interpreting regulations correctly, building sound risk assessments, preparing clear documentation, and designing C&Q processes that are practical and sustainable over time.

Although we have mostly focused on technology until now, the shift in regulatory thinking over the years is worth talking about. The focus has moved toward designing quality into systems from the start rather than only verifying it later, making it perfectly aligned with the concept of "Right First Time," which we introduced earlier. Although regulatory frameworks differ across regions, they increasingly follow the same logic, and as a result C&Q has become more integrated and demanding, requiring broader expertise and not just a traditional team. 

Alongside digitalization, artificial intelligence is emerging as a key tool to support validation. Industry professionals clearly see its potential: 57% believe that AI will be central to the future of validation, even though only 16% of companies currently use it, while 46% still have no concrete plan for adoption. This shows that we are still at the beginning of the maturity curve, but AI is expected to soon assist with complex tasks such as protocol review, data analysis, deviation management, and even planning for periodic requalifications (4).

Where Are We Today? 

The industry is still undergoing this transformation, and it is evident that more companies are in the process of working toward going digital or considering it. This has led some teams to continue using traditional approaches while the transition to digital systems is still underway. This overlap has made work more complex, and it is reflected in the numbers. Because of this, around 66% of professionals reportedly say their workload has increased as they are now managing two systems at once. While this phase is temporary, companies can approach it as a unique opportunity for their teams to gain expertise and a clear understanding of how modern digital C&Q processes will operate in practice.

Looking ahead, it is becoming clear where C&Q is headed, and there is little doubt that the future of C&Q is digital, with test protocols more closely tied to requirements and risk analysis guiding the overall flow. Rather than waiting to address issues all at once at the end, regulators are encouraging a shift toward building quality into the design of systems from the beginning rather than simply verifying compliance afterward. The result, once the transition is complete, will be a leaner and more data-driven approach to C&Q, one that supports innovation rather than slowing it down. Organizations that combine modern tools with strong technical and regulatory expertise will be in a better position to turn quality into a real competitive advantage.

In this evolving landscape, organizations navigating the digital transformation of C&Q can benefit from experienced consultants. These experts help interpret regulations, structure risk-based strategies, and implement modern qualification frameworks—turning the temporary complexity of managing dual systems into an opportunity to gain practical expertise and prepare for a leaner, more data-driven future.

Sources:  

1.    ISPE – Digital Validation Survey / Adozione dei Digital Validation Tools: https://ispe.org/pharmaceutical-engineering/may-june-2025/new-guide-helps-pave-way-digital-validation 

2.    2025 State of Validation Report – Digital Validation & Workload Increase: https://www.bioprocessonline.com/doc/state-of-validation-validation-industry-annual-report-0001

3.    Kneat – Future of Validation / Maturity Levels: https://kneat.com/article/2025-validation-trends/ 

4.    Kneat – AI Adoption in Validation: https://kneat.com/article/2025-validation-trends/