Prevent Quality Failures Before They Happen
Validation Automation for Advanced Manufacturing
From document-heavy, paper-based qualification to reusable template-driven, AI-enabled, intelligent, risk-based, inspection-ready execution.
The Challenge
Qualification and 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.
- Qualification heavily dependent on manual documents and spreadsheets
- Long cycle times for IQ/OQ/PQ and re-qualification
- Limited reuse of validation evidence across assets and sites
- Inconsistent interpretation of regulatory requirements
- Qualification data disconnected from deviations, CAPA, and change management
- Low scalability for new sites, new equipment, and new systems
The SHARP Model of Validation
Standardize. Harmonize. Automate. Risk-Align. Predict.
Standardize
FDA Title 21-derived templates and validation structures. Consistent protocols, traceability, and reporting across sites.
Harmonize
Unified validation approach across facilities, equipment, instruments, processes, and applications. Common taxonomy, risk models, and acceptance criteria.
Automate
Digital workflows for protocol execution, evidence capture, and approvals. Electronic signatures, version control, and audit trails.
Risk-Align
CSA-aligned, risk-based testing and qualification. Focus on what matters for patient safety and product quality.
Predict and Prevent
Validation insights integrated with QMM, audits, deviations, and CAPA. Early identification of repeat failures, delays, and compliance risks.
Over 60% Reusability
End-to-end digital validation lifecycle. Faster execution with fewer resources. Inspection-ready validation evidence at all times.
Validation Scope
Regller qualification automation covers the full spectrum of regulated validation activities:
System Validation
Computer System Validation (CSV), equipment qualification, and infrastructure qualification with CSA-aligned risk-based approach.
Process and Method
Process validation, method validation, and laboratory validation with standardized templates and automated workflows.
Site Qualification
Comprehensive site qualification from facility through equipment to operational readiness with IQ/OQ/PQ automation.
Expected Impact
60%
Time savings on validation activities
70%
Cost savings through template reuse
100%
Inspection-ready evidence at all times
60%+
Reusability across assets and sites
Modernize Your Validation Process
See how the SHARP model can transform your validation lifecycle.