VaultGXP is your all-in-one Digital Pharma Solution
OOS & OOT INVESTIGATION AND REPORTING
In a laboratory setting, an Out of Specification (OOS) incident refers to a test result that falls outside of established acceptance criteria, while Out of Trend (OOT) results indicate a deviation from expected historical data patterns within the established criteria.
- Investigate with Precision. Resolve with Confidence
- Root Cause, Risk, and Remediation—All in One Flow
- Ensure Data Integrity. Be Audit-Ready Anytime
Investigate with Precision-Resolve with Confidence
VaultGxP’s OOS/OOT Investigation and Reporting module offers a compliant, structured framework to manage out-of-specification and out-of-trend results in laboratories and production environments. Whether triggered by stability testing, raw material analysis, or finished product results, the system ensures rapid detection, documentation, and classification of anomalies. Automated notifications, pre-defined investigation templates, and risk-based triaging help teams address critical deviations early—supporting regulatory expectations and maintaining product quality.
Root Cause, Risk, and Remediation—All in One Flow
Each investigation follows a guided workflow from preliminary assessment through root cause analysis, impact evaluation, and final reporting. Users can assign responsible teams, link related records (CAPA, deviations, test results), and ensure traceable documentation at every step. The platform supports hypothesis testing, lab re-testing protocols, and justification records—ensuring consistency and alignment with FDA, EMA, and WHO regulatory guidelines. This enables organizations to close investigations with data-backed decisions and complete compliance.
Ensure Data Integrity. Be Audit-Ready Anytime
VaultGxP centralizes OOS/OOT records with full audit trails, electronic signatures, and role-based access control. Dashboards provide QA and regulatory teams with real-time visibility into open investigations, status updates, and recurring trends. The module not only reduces manual errors and compliance risks but also strengthens organizational accountability. By digitizing the OOS/OOT process, VaultGxP supports data integrity, faster resolution cycles, and enhanced readiness for inspections and audits.
