Capacity Expansion or New Site Qualification Is Slowed by Manual Qualification
When pharma companies expand manufacturing capacity, the bottleneck is not construction.
It is documentation, validation, and regulatory alignment.
• Site Master Plans built manually
• Equipment IQ/OQ/PQ scattered across spreadsheets
• Inconsistent documentation templates
• Review cycles taking months
• Rework during inspections
• ANDA delays due to incomplete validation evidence
The result:
Lost revenue. Delayed launches. Increased inspection risk.
Regller Solution: Digital Site Qualification. Structured. Automated. Audit-Ready.
Regler transforms site qualification into a structured digital workflow built on FDA and global regulatory expectations.
Core Capabilities
1. Structured Site Hierarchy
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Organization → Site → Building → Area → Room → Equipment
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Full asset master integration
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Digital Site Master Plan generation
2. Equipment Qualification Automation
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IQ / OQ / PQ template-driven generation
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Auto-populated metadata (equipment ID, URS link, risk class)
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Version control + audit trail
3. Validation Lifecycle Management
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Draft → Review → Approval → Execution → Close
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Electronic signature
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Locked versioning during review
4. Risk-Based Qualification
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Integrated risk scoring
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CFR-linked compliance checks
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Automatic gap visibility
5. Real-Time Dashboards
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% qualification complete
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Open deviations
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Documentation readiness score
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Inspection exposure heatmap
Who Is This For
Designed for Growing Pharma & CDMOs
• CDMOs expanding US manufacturing
• Generics manufacturers preparing ANDA
• Biotech scaling to commercial production
• Sites recovering from FDA 483 observations
• Companies modernizing paper-based validation
From Construction to FDA Readiness
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Construction
↓
Asset Registration
↓
Risk Assessment
↓
IQ/OQ/PQ Generation
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Review & Approval
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Inspection-Ready Documentation
Why Regller Is Different?
Not Just Document Storage. A Regulatory Intelligence Platform.
Most systems store documents...
Regler:
✔ Builds documents using regulatory-aligned templates
✔ Connects equipment to risk and CFR codes
✔ Tracks review and approval workflow
✔ Flags compliance gaps automatically
✔ Prepares validation evidence for ANDA submission
