Hari Kiran Chereddi, Founder, Managing Director and Chief Executive Officer, and Sowjanya Varma, Chief Information Officer, HRV Pharma, feature in the September 2026 issue of Express Pharma — on why the industry’s next advantage will come from better decisions rather than more software.
Recording Versus Reasoning
Pharma was never short of systems. ERP, LIMS and CRM platforms answer one question exceptionally well — what happened — and they answer it after the fact. Very little was built to answer what should happen next, and why. RIKO™ was built to close that gap, because HRV Pharma needed it to run a network of more than 50 FDA and EU-GMP certified partners across 55 countries.
It Recommends. Humans Decide.
Every RIKO™ output shows its working — the data points behind a recommendation and the weight each carried. The decision-maker can agree, override or challenge it. Every override is logged with its reason, and that record becomes the clearest signal of where the model needs to improve.
Validation follows the same discipline applied to any analytical method in a GMP environment: retrospective testing against historical outcomes, documented accuracy, defined thresholds, periodic review. Computerised systems have been validated under GAMP principles for decades. An AI recommendation engine is held to the same evidentiary standard.
From Reactive to Predictive Compliance
Compliance today is retrospective — inspections surface what went wrong months ago. Continuous monitoring of a supplier’s GMP status, inspection history, deviation patterns and regulatory alerts changes that. Three shifts are likely over five years:
- Continuous monitoring becomes a quality indicator in its own right during inspections.
- Data standards emerge that let intelligence move across company boundaries without compromising confidentiality.
- Supplier qualification starts to include data connectivity. A partner who cannot be monitored continuously is a higher-risk partner by definition.
The Barriers Are Human, Not Technical
- Data ownership politics. Each function treats its data as territory. Integration is a governance problem, solvable only from the top.
- No single version of truth. Different molecule names, supplier codes and filing statuses across teams. The data has to be fixed before intelligence can be built on it.
- Conservatism. An AI system influencing a compliance decision feels riskier than a spreadsheet doing the same thing — even when it is more auditable.
Express Pharma, September 2026. Interview by Kalyani Sharma.
