Quality
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