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QMS Suite

- Integrated Quality Management Modules -

Connect deviations, CAPA, change control, audits and reviews in one compliant quality system.

01

Change Control

Controlled Change Management Across Quality Systems

Manages the full lifecycle of controlled changes — initiation, risk assessment, impact evaluation, multi-tier approval, and implementation tracking — ensuring every change to processes, equipment, documents, or systems is reviewed and documented to GMP standards.
Change InitiationRisk AssessmentApproval RoutingEffectiveness ReviewAudit Trail
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Change Control — Workflow & Approval Status

Change Initiation

Structured forms with category & urgency classification.

Risk Assessment

Quality risk matrix with impact-level scoring.

Approval Routing

Configurable multi-tier approval chains.

Action Items

Task assignment with ownership & due-date tracking.

Change Reports

Status dashboards and overdue change alerts.

CAPA & Deviation Link

Associate changes with related CAPAs and deviations.

02

Deviation Management

Planned & Unplanned Deviation Investigation Workflows

Captures, classifies, and manages both planned and unplanned deviations from approved procedures, specifications, or regulatory requirements — with root cause analysis tools, containment actions, and CAPA linkage so every deviation is resolved, prevented, and documented to GMP standards.
Root Cause AnalysisContainment ActionsCAPA LinkageTarget DatesAudit Trail
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Deviation Management — Investigation Workflow

Deviation Reporting

Immediate capture with impact & severity scoring.

Root Cause Analysis

5-Why & fishbone tools built into the workflow.

Containment Actions

Immediate corrective steps with assignment.

CAPA Generation

One-click CAPA creation from any deviation record.

Trend Analysis

Recurring deviation patterns identified automatically.

Regulatory Reports

GMP-ready reports for site quality review.

03

CAPA

Corrective & Preventive Action Management

End-to-end CAPA management from source identification through effectiveness verification — tracking root cause, action plan, responsibility, target dates, and evidence — ensuring compliance with 21 CFR Part 211, ICH Q10, and ISO 9001.
Source IdentificationAction PlanningEffectiveness CheckEvidence AttachmentsOverdue Alerts
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CAPA — Action Plan & Progress View

Source Tracking

CAPA linked to deviations, audits, complaints.

Action Plan

Step-by-step plan with individual task owners.

Approval Workflow

QA review and final approval with e-signature.

Effectiveness Review

Evidence-based verification after completion.

Escalation

Auto-escalation for overdue & high-risk CAPAs.

CAPA Dashboard

Status overview with ageing & closure metrics.

04

Auditing Management

Plan, Execute & Track Internal and External Audits

Comprehensive audit management for internal GMP audits, external supplier audits, and regulatory inspection readiness — with configurable checklists, finding classification (critical/major/minor), CAPA linkage, and audit history reporting so no finding is ever lost or unresolved.
Audit SchedulingSmart ChecklistsFinding ClassificationCAPA IntegrationAudit Reports
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Auditing — Checklist & Findings Tracker

Audit Planning

Annual schedule with type, scope & auditor.

Checklist Library

GMP, ISO, and custom checklist templates.

Finding Management

Critical / major / minor classification & evidence.

CAPA Linkage

Direct CAPA creation from each finding.

Audit History

Complete records for inspection readiness.

Trend Reports

Recurring findings across departments & periods.

05

Complaints Management

Structured Product Complaint & Market Feedback Handling

Manages the complete customer complaint lifecycle — from receipt and acknowledgement through investigation, response, and trend monitoring — classifying complaints by severity and product, triggering lab sample investigations, and tracking regulatory reportability for pharmacovigilance compliance.
Complaint ReceiptSeverity ClassificationLab InvestigationCustomer ResponseTrend Monitoring
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Complaints — Intake & Investigation View

Complaint Intake

Web form or manual entry with product & batch link.

Sample Investigation

Lab retesting workflow triggered from complaint.

Investigation Assignment

Multi-department investigation with deadlines.

Customer Letters

Templated regulatory response letters.

Reportability Check

Flags serious complaints for regulatory reporting.

Complaint Trends

Product / batch / type pattern analysis.

06

Oasis APQR

Automated Annual Product Quality Review

Automates the ICH Q7 / 21 CFR 211.180(e) Annual Product Quality Review by aggregating batch, QC, stability, change control, complaint, and deviation data into a structured annual report — cutting APQR preparation from weeks to hours with auto-compiled statistics and trend analysis.
Batch AggregationQuality Trend StatsAuto PDF ReportICH Q7 Compliante-Approval
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APQR — Annual Product Quality Review Report

Data Aggregation

Auto-pulls batches, QC, stability & complaint data.

Statistical Summary

Yield, OOS, CAPA, deviation counts per product.

Auto PDF

Formatted APQR report generated in one click.

Review Approval

QA/QP review with electronic signature.

Year-on-Year

Prior-year comparison for trend identification.

APQR Archive

Searchable repository of all historical reports.