FOR IMMEDIATE RELEASE
cResults LLC Unveils Smart-FDA: AI-Driven Compliance Intelligence Platform for Life Sciences
Early-access launch May 2025 | General availability early 2026
Sunny Isles, FL – May 17, 2025 – cResults LLC, a leading provider of digital planning and scheduling, quality and compliance solutions for the life-science industry, today announced Smart-FDA; an advanced platform that harnesses artificial intelligence to deliver real-time, role-specific insights from FDA 483 observations.
Smart-FDA ingests and analyzes more than 20,000 curated FDA 483 observations, each automatically cross-referenced to the relevant sections of the Code of Federal Regulations (CFR). By tailoring results to a user’s role, the platform surfaces only the most pertinent findings and guidance, reducing information overload and helping organizations close compliance gaps faster.
“Smart-FDA puts the collective intelligence of decades of FDA inspections at each quality professional’s fingertips,” said Rafi Maslaton, Founder and President of cResults. “Our goal is to transform raw regulatory data into actionable, role-based knowledge that drives continuous improvement and audit readiness.” Maslaton added, “We also enable our customers to stay aligned with all FDA quality requirements and ensure inspection readiness.”
Key Smart-FDA Capabilities
- ✅ Conversational Queries: Natural-language prompts like “Show the top 10 microbiology observations from the past five years” return precise, ranked results.
- ✅ Role-Based Dashboards: Users receive observation feeds tailored to their specific responsibilities
- ✅ Guidance Search: A lightning-fast search engine links every observation to its applicable CFR citation and FDA guidance documents, speeding up root-cause analysis and training.
Rollout timeline
- ✅ May 2025 – Limited release for existing Smart-QC and Smart-QA customers.
- ✅ Early 2026 – Full commercial availability to the broader life-science market.
About cResults LLC
cResults LLC is an innovator in digital planning and scheduling and quality-management solutions, enabling pharmaceutical, biotechnology, and medical-device companies to achieve operational excellence and maintain regulatory compliance. Flagship products Smart-QC and Smart-QA are trusted by leading global manufacturers.
Media Contact: info@cResultsconsulting.com © 2025 cResults LLC. All rights reserved.