Coding and FDCE: Redefining regulatory compliance in healthcare
Express Pharma
|December 2025
Abhijeet Vaidya, Head of Data & AI Practice, Emids opines that as AI reshapes healthcare technology, regulatory compliance is shifting from rigid, rule-based systems to adaptive, intelligent frameworks. Concepts like Vibe Coding and FDCE are enabling this transformation
-
Regulatory compliance in healthcare and life sciences traditionally relied on rigid, rule-based systems, often treated as a checklist rather than a dynamic capability. With artificial intelligence reshaping how organisations design and deploy digital systems, compliance itself is undergoing a transformation.
Two emerging concepts such as Vibe Coding and Forward-Deployed Context Engineers (FDCE) are helping organisations shift from reactive oversight to proactive, context-aware compliance. But before diving into these ideas, it's important to understand how software development has evolved.
For decades, enterprise software followed a deterministic path, built around clearly defined business rules, workflows, and user requirements. In contrast, Al-driven development operates on probabilistic systems that learn from data and evolve over time. The difference is not just technical; it is philosophical.
In a traditional setup, or enterprise approach, engineers define exactly how the system should behave. In an AI-driven setup, however, engineers teach the system to learn from data and experience. For example, a nurse manually tracking patient cases represents the enterprise approach, while an AI model that predicts which patients are at risk of hospitalisation in the next 30 days reflects the datadriven mindset. Similarly, the enterprise approach might create a rule-based claims processing system that flags high-value claims, whereas an AI-driven system can detect subtle anomalies to identify potential fraud or waste.
Dit verhaal komt uit de December 2025-editie van Express Pharma.
Abonneer u op Magzter GOLD voor toegang tot duizenden zorgvuldig samengestelde premiumverhalen en meer dan 9000 tijdschriften en kranten.
Bent u al abonnee? Aanmelden
MEER VERHALEN VAN Express Pharma
Express Pharma
The invisible threat: Why packaging inks are the next major recall risk for pharma
Jatin Takkar, Head - Product Safety & Regulatory, Siegwerk India writes that packaging is emerging as a potential source of contamination due to unsafe ink chemistries. With global standards evolving, the industry must shift from reactive compliance to a proactive 'Safe by Design' approach that ensures packaging inks are as safe as the medicines they guard
4 mins
December 2025
Express Pharma
Beyond the machine: How intelligent packaging design elevates parenteral delivery
For sensitive parenteral products, the packaging is as critical as the drug itself. Uhlmann demonstrates how deep design competence turns packaging challenges into patient-centric solutions
2 mins
December 2025
Express Pharma
Ensuring Clean Room Integrity with Prime Clean Reset High-Speed Doors: Minimizing Air Permeability and Leakages
High-speed doors for clean rooms are specialized industrial doors essential for maintaining controlled environments.
3 mins
December 2025
Express Pharma
JULABO introduces Green Edition Refrigerated Circulators using natural refrigerants for sustainable lab cooling
JULABO launches its Green Edition range of refrigerated circulators designed to support laboratories in reducing carbon emissions, improving energy efficiency, and aligning with global environmental regulations
2 mins
December 2025
Express Pharma
Flexotherm Heating Tapes & Cords
Tempo's Flexotherm heating tapes and cords provide a safe, flexible, and efficient solution for maintaining solvent temperature across a wide range of industrial processes
1 mins
December 2025
Express Pharma
PRUV® -The original Sodium Stearyl Fumarate
JRS Pharma's PRUV® is the original sodium stearyl fumarate (SSF) introduced in the market over 20 years ago
5 mins
December 2025
Express Pharma
We continue to invest heavily in quality, regulatory compliance, and modernisation
Rishad Dadachanji, MD, Kaisha Packaging shares insights on emerging industry trends, new technologies showcased at CPhI & P-MEC, and how the Dadachanji Group is strengthening its integrated ecosystem to serve both domestic and global pharma markets
3 mins
December 2025
Express Pharma
Romaco begins local format part production in India
The Noack N 950E blister packaging machine with Indian-produced format parts to debut at CPHI & PMEC India 2025, followed by installation at the Romaco India Experience Centre in Hyderabad
4 mins
December 2025
Express Pharma
We built our business by obsessing over excipients
Shivang Zaveri, Director, Transchem Corporation Pharma; discusses Transchem's approach to excipients, innovation, and market strategy with Express Pharma.
2 mins
December 2025
Express Pharma
India is a cornerstone of Fette Compacting's global strategy
Ashok Gourish, Managing Director, Fette Compacting India, discusses India's pivotal role in the company's global growth, backed by expanded services, digital transformation support, and a strengthened Competence Center in Goa, in conversation with Express Pharma
5 mins
December 2025
Listen
Translate
Change font size

