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Recently Presented in ISPE Conference - Smart-FDA discusses the usage of 483s and other information to assess compliance risks
Analysis of "big data" has many applications in the pharmaceutical industry, one of which is to improve risk assessment of manufacturing facilities. "Unstructured information from FDA— including 483s, inspection details, recalls, warning letters, and the CFR [Code of Federal Regulations]—can be examined to help identify compliance risk and determine what problem areas to address first, to avoid past mistakes, or to audit vendors," explained Rafi Maslaton, president at cResults Consulting, in a presentation at the ISPE event. His company has developed a platform called Smart-FDA, which creates a database of these public data and uses software to analyze and extract useful information, in conjunction with an advanced projection algorithm to assess specific sites and overall company compliance related risks.
cResults LLC Launches Smart-FDA, an AI-Driven Compliance Platform for the Life Sciences Industry
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 the launch of Smart-FDA, an advanced artificial-intelligence platform designed to deliver real-time, role-specific insights derived from FDA 483 inspection observations.
Smart-FDA ingests and analyzes more than 20,000 curated FDA 483 observations, each automatically cross-referenced to the applicable sections of the Code of Federal Regulations (CFR). By tailoring insights to a user’s role, the platform eliminates information overload, accelerates gap closure, and strengthens inspection readiness across organizations.
“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 LLC. “Our mission is to transform raw regulatory data into actionable, role-based knowledge that drives continuous improvement and audit readiness.” Maslaton added, “We also empower our customers to remain fully aligned with FDA quality requirements at all times.”
Key Smart-FDA Capabilities
- Conversational Queries: Natural-language prompts such as “Show the top 10 microbiology observations from the past five years” deliver precise, ranked results.
- Role-Based Dashboards: Personalized observation feeds aligned with individual responsibilities and functional areas.
- Guidance Search: A high-speed search engine linking every observation to its relevant CFR citation and FDA guidance, accelerating root-cause analysis and training.
Rollout Timeline
- May 2025: Limited early-access 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, scheduling, and quality-management solutions, enabling pharmaceutical, biotechnology, and medical-device organizations to achieve operational excellence while maintaining 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.
Smart-FDA DATA SHEET
The first cloud based platform to support companies regulated by the FDA in preventing 483s by leveraging a robust projection algorithm and implementing continuous process improvements...