Quality Management and FDA Compliance Solutions for the Blood and Tissue Industries
Blood centers and blood and tissue manufacturers are regulated by strict quality requirements to ensure the safety of the world’s blood supply. Sparta Systems’ quality management software solutions enables these organizations to improve compliance, increase quality and reduce costs by centralizing and integrating all quality processes, including customer complaints, supplier quality, internal and external audits, change control, corrective and preventive actions (CAPA), preventive maintenance and calibration, and training management.
Sparta Systems enables organizations to 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. With Sparta Systems' quality management solutions 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.
Sparta Systems offers rapid deployment solutions that enable organizations to quickly and easily migrate from paper-based systems and spreadsheets to an automated, electronic quality management system.
Benefits of Sparta Systems’ Quality Management Solutions for the Blood and Tissue Industries:
- Boost ROI and improve efficiency as a result of streamlined processes
- Centralize data management and reporting through consolidated tracking and workflow management
- Facilitate compliance with regulatory mandates and industry guidelines
- Provide reports such as the FDA’s biological product deviation reporting (BPDR) to regulatory agencies on a timely basis
- Automatically generate reports in electronic format from structured audit-trailed data fields that meet industry and regulatory guidelines
- Increase operational transparency through automated alerts and extensive reporting capabilities featuring dashboards and executive overviews