QOL Medical

Yaritza Stella is a quality and compliance leader with more than two decades of experience across the life sciences industry. She specializes in quality assurance, human performance improvement, risk management and regulatory compliance in highly regulated environments.

The Impact of Human Performance on Quality

From my perspective, one of the most significant trends in the chemical industry is human performance and the direct impact it has on quality assurance and quality compliance. 

Human interaction remains a critical factor across quality and compliance activities. While AI is becoming a rising trend, it requires careful consideration as it does not have the same human interaction that remains essential in these environments.

When issues arise, we do not stop at calling them human error. In my experience, that alone does not explain the issue. I often remind my team that many errors involve human interaction because people are behind the transactions. That is why we look deeper to understand what actually contributed to the error. Once the root cause is understood, recurrences are prevented by establishing fixes and improvements. 

Risk assessment is another valuable tool and is widely supported by regulatory agencies through ICH guidelines. While risk assessment plays an important role in quality systems, it should not be used to justify non-compliance. A low-risk assessment is not a valid reason to disregard a regulatory requirement. Organizations can document risk, propose corrective actions and implement mitigation strategies, but they must still meet the requirements established by regulatory authorities. 

Maintaining Data Integrity in a Digital Environment

Throughout my career, digital transformation has remained a constant presence across the industry. For organizations in regulated environments, that transition requires compliance with the FDA 21 CFR Part 11 requirements governing electronic records and electronic signatures, as well as computer system validation.

With geopolitical events continuing to create uncertainty, supply disruptions can have a direct impact on patients for companies like ours that work with orphan drugs for rare diseases.

Data integrity is equally critical, as organizations must be able to demonstrate the accuracy of their digital records. Digital systems can also help standardize documentation by requiring users to enter the information that is required. This can improve the completeness and consistency of records while supporting compliance objectives. 

Preparing for Supply Chain Uncertainty

The COVID-19 pandemic reminded us how vulnerable supply chains can be during periods of disruption. Over the years, many manufacturers moved material sourcing and CDMO activities offshore for the economic benefits they offered. However, COVID highlighted how important it can be to have materials sourced and manufactured within the U.S., where they can be accessed more quickly and reliably when disruptions occur.

The pandemic also challenged long-standing assumptions around inventory management. For years, organizations focused on process performance, six sigma tools and minimizing inventory to avoid what was wrongfully perceived as waste. When supply chains were disrupted, many companies discovered they had only a few months of materials available and could not obtain additional supplies from vendors when needed.

That experience led to a different way of evaluating risk, including identifying materials with longer lead times and determining where additional inventory may be necessary. With geopolitical events continuing to create uncertainty, supply disruptions can have a direct impact on patients for companies like ours that work with orphan drugs for rare diseases. 

Strengthening Domestic Supply Capabilities

As supply chains continue to face pressure from geopolitical events and other disruptions, organizations should focus on strengthening domestic production capabilities. Bringing more manufacturing and critical material sourcing back to the U.S. can help improve preparedness when external conditions become challenging. 

While global partnerships remain important, recent events have highlighted the need to strengthen domestic manufacturing and material supply capabilities to reduce vulnerability during disruptions. Reducing reliance on offshore sourcing for critical materials remains an important step toward strengthening resilience and preparing for future disruptions.