From document-heavy, paper based validation to reusable template driven, AI enabled, intelligent, risk-based, inspection-ready execution.
Validation Automation for Modern Digital GxP Organizations
Computer System Validation
Equipment Qualification
Process Validation
Infrastructure Qualification
Method Validation
Laboratory Validation
Site Qualification
Validation remains one of the most resource-intensive and risk-prone activities in regulated industries. Despite significant investment, many organizations still rely on fragmented tools, manual document handling, and retrospective evidence assembly. This leads to long validation cycles, inconsistent execution, limited visibility, and increased inspection risk.
Regller Validation Automation modernizes validation by using pre-populated templates, fully compliant with FDA Title 21 that can be copied over to validation projects for standardized, harmonized and automated validation. Regller validation workflows uses a risk-based, data-driven, and inspection-ready, aligned with FDA expectations, CSA principles, and global GxP regulations.
Validation is a burden
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Validation heavily dependent on manual documents and spreadsheets
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Long cycle times for IQ/OQ/PQ and re-qualification
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Limited reuse of validation evidence across assets and sites
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Inconsistent interpretation of regulatory requirements
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Inconsistent quality deliverables
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Validation data disconnected from deviations, CAPA, and change management
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Low scalability for new sites, new equipment, and new systems
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Validation is expensive