Pharmaceutical Manufacturing Site Qualification Software
بواسطة Regler
Pharmaceutical site qualification automation with templates and AI monitoring and FDA compliance
Manufacturing Site Qualification & ANDA Readiness Platform
Regler is a pharmaceutical manufacturing site qualification, quality maturity scorecarding, ANDA readiness and risk prediction platform built on Microsoft Platform. It digitizes site qualification, equipment validation (DQ/IQ/OQ/PQ), Process Validation, People Qualification and ANDA preparation using a structured, template-based document framework aligned with FDA expectations. Regller Site Qualification establishes an AI-enabled, standardized approach to qualifying facilities, utilities, systems, applications, and equipment aligned with FDA and global GxP expectations. The platform harmonizes qualification requirements across sites, uses standard templates, digitizes and automates execution and captues evidence ensuring consistent GMP readiness. By automating qualification workflows and documentation, Regller helps organizations reduce variability, and improve quality.
The platform enables manufacturers and CDMOs to manage site hierarchy (company → site → building → area → room → equipment), generate validation documents from controlled templates, AI generated content, and track qualification status in real time. All validation activities are structured, version-controlled, and electronically approved within a compliant workflow.
AI-driven automation continuously evaluates regulatory requirements, identifies compliance gaps, and monitors risk exposure across sites and projects. The system provides traceability matrices, electronic signature workflows, structured document assembly, and real-time readiness dashboards. Continuous compliance monitoring ensures validation status, documentation completeness, and inspection preparedness are always visible.
By integrating site assets, validation lifecycle, and regulatory intelligence into one controlled environment, Regler reduces qualification cycle time, minimizes rework, and improves the probability of regulatory approval for pharmaceutical manufacturers and CDMOs.
Contact ks@regller.com for additional details.
Key Manufacturing Capabilities
• End-to-end manufacturing site qualification management
• Equipment validation automation (IQ/OQ/PQ)
• Process validation documentation control
• Automated Computer System Validation (CSV)
• ANDA/NDA/BLA document preparation and structured assembly
• Real-time compliance checks and readiness dashboards
• Electronic signature workflows and audit trail
ANDA Preparation & Automated Readiness Checks
Regler transforms ANDA preparation into a controlled digital process.
• Structured ANDA document package builder
• FDA checklist-aligned document framework
• Automated completeness and quality checks
• URS–FS–IQ/OQ/PQ traceability matrices
• Continuous readiness scoring before submission
AI-driven automation continuously evaluates document integrity, validation evidence, and regulatory alignment. Compliance gaps are flagged early—reducing rework, preventing submission delays, and improving approval confidence.
Continuous Monitoring & Inspection Readiness
Regler continuously monitors validation progress, documentation completeness, and regulatory risk exposure across sites.
Dashboards provide:
• % site qualification complete
• Equipment/Instrument/System/Process validation status
• Open deviations and risk areas
• ANDA submission readiness score
• Inspection exposure indicators
This ensures site leadership and regulatory teams always know whether a facility is submission-ready and inspection-ready.
Business Impact
• Reduced site qualification cycle time
• Faster ANDA preparation and review cycles
• Improved inspection readiness
• Lower documentation rework
• Increased probability of regulatory approval
Contact ks@regller.com for additional details.