VaultGXP is your all-in-one Digital Pharma Solution
DEVIATION MANAGEMENT
A Deviation Management System is a structured process used to identify, document, investigate, and resolve deviations from established standards, procedures, or specifications within an organization. It's particularly vital in regulated industries like pharmaceuticals and life sciences, ensuring product quality, safety, and compliance with regulations.
- Capture, Investigate, Correct — with Confidence
- Structured Workflows for Root Cause to Resolution
- Digital Deviations-Stronger Compliance Culture
Capture,Investigate,Correct — with Confidence
VaultGxP’s Deviations Management module provides a robust framework to identify, document, and resolve deviations across manufacturing, laboratory, and quality operations. Whether it’s a process non-conformance, equipment anomaly, or data deviation, the system enables teams to initiate records instantly, assign responsibilities, and follow structured workflows. Built-in compliance controls ensure complete traceability, real-time visibility, and alignment with GxP, FDA, and international regulatory expectations—minimizing risks while maintaining operational integrity.
Structured Workflows for Root Cause to Resolution
From initial detection to final closure, the module supports root cause analysis, risk assessment, impact evaluation, and corrective/preventive action (CAPA) linkage. Investigations are guided by standardized templates and decision trees that help eliminate guesswork and promote consistent documentation. Review and approval flows are role-based and time-stamped, enabling transparent collaboration across QA, production, and support teams. This disciplined process reduces recurring issues and strengthens your organization's continuous improvement efforts.
Digital Deviations-Stronger Compliance Culture
VaultGxP’s digital platform replaces fragmented spreadsheets and paper forms with secure, centralized deviation tracking. Dashboards, automated alerts, and audit trails provide real-time insight and control across sites and departments. Teams can monitor trends, detect recurring patterns, and improve compliance responsiveness. By embedding quality at the core of daily operations, the Deviations Management system enhances accountability and supports a culture of quality excellence across the organization.
