Quality and FDA Compliance for Blood and Tissue Companies
Blood centers and blood and tissue manufacturers are regulated by strict quality requirements to ensure the safety of the world’s blood supply. Sparta quality management software enables these organizations to improve compliance, increase quality, and reduce costs by centralizing and integrating all quality processes, including:
- Customer Complaints
- Supplier Quality Management
- Internal and External Audits
- Change Control
- Corrective and Preventive Actions (CAPAs)
- Preventive Maintenance and Calibration
- Training Management
You can more efficiently manage and enforce current good manufacturing/laboratory/clinical practices (cGxPs), compliance guidelines from regulatory agencies and industry associations such as the FDA and AABB (American Association of Blood Banks) and organizational SOPs.
All issues, actions and changes reside in a single, easy-to-configure, web-based system that integrates quality information between quality assurance (QA), donor collections, hospital services, laboratory services and other departments.
Rapidly deployable solutions enable organizations to quickly and easily migrate from paper-based systems and spreadsheets to an automated, fully digital quality management system.
Benefits of Sparta Quality Solutions for Blood and Tissue Companies:
- Boosts ROI and improves efficiency as a result of streamlined processes.
- Centralizes data management and reporting through consolidated tracking and workflow management.
- Facilitates compliance with regulatory mandates and industry guidelines.
- Provides reports such as the FDA’s biological product deviation reporting (BPDR) to regulatory agencies on a timely basis.
- Automatically generates reports in electronic format from structured audit-trailed data fields that meet industry and regulatory guidelines.
- Increases operational transparency through automated alerts and extensive reporting capabilities featuring dashboards and executive overviews.