Site Qualification
Template based qualification of new manufacturing sites, expansions, and facilities to speed up the production.
Business Needs
New manufacturing sites, expansions, and facility changes require timely and compliant qualification of buildings, utilities, and critical infrastructure. Traditional site qualification is document-heavy, slow, and difficult to scale across regions.
Regller Solution
Regller digitizes site qualification by providing structured workflows for facility, utility, and infrastructure qualification aligned with FDA, EU GMP, and global standards. Qualification evidence is captured once and reused across projects, audits, and inspections.
Key Capabilities
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Risk-based qualification planning
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Digital IQ/OQ execution for facilities and utilities
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Standardized protocols derived from Title 21
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Centralized qualification evidence repository
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Inspection-ready site qualification reports
Benfits
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Faster site readiness and regulatory approvals
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Reduced rework and documentation effort
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Consistent qualification across global sites
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Improved inspection outcomes