Quality
The Purity, Viability, and Quality You Need™ for Every Product
STEMEXPRESS QUALITY POLICY
At StemExpress Quality is an integral part of our StemExpress’ corporate business principles.
We comply with all regulatory requirements, maintain and review the effectiveness of the Quality Management System regularly, and manufacture high quality products that meet or exceed our customer’s needs and requirements.
Focusing on our customers, we ensure that our innovative technologies are targeted to the right problems in the right way, and that our products are effective and reliable.
QUALITY BY DESIGN
GLP regulatory-compliant collection centers and laboratories
Institutional Review Board (IRB) regulatory compliance
Vendor Qualification Program ensures all vendors meet StemExpress Quality System standards of excellence
QUALITY BY INFRASTRUCTURE
Raw Material Handling and Tracking System
Powerful Enterprise Resource Planning System
Off-site cloud-based data back-up storage
QUALITY BY ASSURANCE
Corrective Action/Preventive Action System
Quality Tracking System
Audit Management System
Product Failure Analysis
STEMEXPRESS QUALITY MANAGEMENT SYSTEM
Developed to support StemExpress fast-growing operations, our Quality Management System (QMS) ensures quality throughout all aspects of our products and services. For our clients, the StemExpress QMS is designed for compliance, including GxP, ISO and e-signatures.
DOCUMENT CONTROL
Permission based access/privileges
Full system wide search ability across all data and attached files
Full document lifecycle management from draft to retirement
TRAINING
Create a course syllabus from all effective documents
Automated email alerts let users know pending or over-due training requirement
Log live training events or assign proficiency test for any users or group
ISSUE AND CAPAS
Log an issue for any internal or external site
Issues can be linked to unlimited CAPAs and assigned to an investigator group
Traditional process for Assessment, Root Cause Analysis and Action Plan
AUDIT AND SUPPLIER QUALIFICATION
Manage recurring audits for all sites
Edit audits live and upload completed documents and attachments late
Share all audit aspects with auditee