Enforce strict procurement rules. Only allow purchase orders to be raised against active, qualified suppliers.
Automated notifications alert quality managers prior to supplier certificate, license, or audit expirations.
Combine quality metrics, audit findings, delivery timeliness, and risk ratings into interactive dashboards.
Link supplier audit findings directly to corrective actions, tracking resolution progress inside QMS.
Explore the rich feature-set built to satisfy GxP validation requirements and maximize quality assurance.
Onboard vendors efficiently. Suppliers securely upload their GMP/ISO certifications, quality agreements, licenses, and insurance details.
Classify suppliers (Critical, Major, Minor) using built-in risk modeling based on material impact, vendor performance, and location.
Schedule, track, and document supplier audits. Centralize audit plans, checklists, findings, and final audit reports.
Natively enforce compliance. Control active supplier status, lock non-conforming vendors, and map AVL categories.
Generate annual or quarterly scorecards. Track metrics such as OOT raw material batches, audit deviations, and delivery accuracy.
When vendor audit findings reveal issues, raise supplier-facing CAPAs. Track implementation, evidence uploads, and quality approvals.
Our software enforces a strict, step-by-step compliant process, guiding assets or audits from draft onboarding to final validation.
Vendor fills out questionnaire, uploads credentials (ISO 9001/14001, GMP, FDA license), and signs quality agreements.
Quality assurance reviews supplier documents, performs risk classification, and sets future audit frequencies.
Auditors perform evaluations against checklist items, logging observations, notes, and compliance ratings directly in-system.
If audit findings require corrective actions, vendor is notified, uploads evidence of resolution, and QA approves.
QA signs off with electronic signatures (21 CFR Part 11 compliant), activating the supplier on the Approved Vendor List.
System calculates performance scores from delivery logs and batch tests, updating supplier risk grades.
As certificates approach expiration, the system auto-notifies the supplier to upload renewals, scheduling recurring audits.
This module operates independently but integrates natively with other QMS processes to ensure closed-loop compliance and automatic record updates.
Vendor onboarding and qualification procedures are directly governed by vendor control SOPs linked in the supplier portal.
Supplier quality agreements, specifications, and NDAs are routed, approved, and version-controlled via Document Control.
Supplier-related material defects automatically trigger a supplier CAPA ticket, linking directly to the QMS investigation database.
Reduce human error, save quality assurance overheads, and streamline regulatory compliance.
Ensure raw materials are only sourced from certified, validated suppliers, preventing batch contamination or regulatory citations.
Automated email alerts track expiring certificates, audit due dates, and open CAPA deadlines without manual monitoring.
Keep all audit plans, historical checklists, supplier communications, and evidence packages in one compliant vault.
Leverage automated scorecard calculations to identify high-performing suppliers and mitigate critical vendor failure risks.
Fully optimized to support critical environments with strict GxP, ISO, or GLP compliance requirements.
We combine cutting-edge software design with rigorous pharmaceutical validation methodologies.
Learn MoreComplies with electronic records standards. Restricts AVL changes and audit approvals with dual e-signatures.
Enterprise-grade data hosting with multi-layered firewalls, encryption, and automatic redundancy.
Dedicated secure portal for vendor uploads, reducing email trails and keeping audit files structured.
Every supplier profile update, audit report sign-off, or status change logs date, user, and action details.