New I
QACV Consulting
2026 AI Program
Development

“AI/ML is transforming industry
— but Compliance is falling behind.”

Article by Robert J. Wherry, MSc, MS, CPIP
Vice President, AI Compliance Innovation, QACV Consulting.

Artificial Intelligence (AI) and Machine Learning (ML) are now embedded across regulated industries. From predictive analytics and automation to quality monitoring and decision support, nearly every organization is leveraging AI/ML in some capacity. Innovation is moving fast. Compliance, however, is not.

Most companies are attempting to force-fit AI/ML systems into traditional Computer System Validation (CSV) or Software as a Medical Device (SaMD) frameworks. These legacy approaches were designed for static, deterministic software — not data-driven models that are capable of adapting to new data. Paradigms are changing and the compliance approach must change also to prevent regulatory risks.

Documentation is often the weakest link. AI/ML development is typically iterative and agile, yet records are frequently scattered across slide decks, informal project notes, and disconnected files. Critical elements such as model assumptions, risk assessments, data governance decisions, and performance monitoring plans are rarely structured in a way that is inspection-ready. In a regulated environment, this creates significant exposure.

Until recently, regulatory agencies provided limited oversight specific to AI/ML systems. Now, authorities are developing clearer expectations around lifecycle management, transparency, risk controls, and ongoing performance oversight of AI-driven systems. Organizations that continue to rely on outdated compliance and validation models will struggle as scrutiny increases.

Likewise, current industry guidance is often written for AI specialists and data scientists. It lacks of holistic view of how AI/ML impacts the broader quality system. This makes it difficult for QA, RA, and CSV professionals to interpret and apply effectively.

Organizations that build structured AI/ML governance today will not only reduce regulatory exposure — they will accelerate innovation with confidence, strengthen audit readiness, and gain a measurable competitive advantage. The future belongs to companies that innovate boldly — and govern responsibly. Our newly launched AI Compliance Center of Excellence (AI CCoE), stands at the intersection of innovation and regulatory rigor, enabling organizations to unlock AI’s full potential while maintaining the highest standards of compliance and accountability.

AI CCoE SERVICES INCLUDE

trainings

Strategic training, help understand the emerging regulatory expectations.
Provide the historical context to explain the “Why?” behind regulatory requirements.
Tactical training with introduction to AI/ML and the appropriate compliance controls specifics for Quality and Compliance experts.