Solutions for the Blood and Tissue industries
Concerns over donor safety, tissue donor scandals, and lack of funding and resources for blood centers have plagued the blood and tissue industry for many years. FDA has significantly increased oversight of laboratories and blood centers, with its Biologics Division now inspecting all facilities at least once every two years, and "problem facilities" subject to inspection more frequently.
Sparta Systems provides unique industry solutions to any organization involved in collection, processing, testing, manufacturing, and administration of licensed blood, blood components, tissue and cellular products. Sparta's TrackWise software provides pre-packaged configuration and results in cost-effective solutions, which require minimal resources to implement, validate, and maintain.
Sparta specializes in assisting small and medium size organizations migration from paper-based systems and spreadsheets to electronic and automated process systems. We are proficient in working in validated environments and can provide turn-key validation solutions if needed.
TrackWise Enterprise Quality Management Software
TrackWise is a web-based enterprise quality management software solution that enables members of the blood industry to comply with 21 CFR Parts 600, 601, 606, 610 regulations required by AABB and other industry standards. TrackWise is the only solution that provides centralized and consolidated tracking, workflow management, and reporting for all critical business processes. It enables blood banks and blood manufacturers to achieve best in class results by consolidating redundant systems, reducing manual operations, and implementing best-of-breed technology.
Select a TrackWise solution from the list below:
Industry Solutions
- Quality Management
- Error and Deviation Management, Customer Complaints, Supplier Quality, Internal and External Audits, Change Control, Corrective and Preventive Actions (CAPA), Calibration and Preventive Maintenance
- Training Management & Employee Qualifications
- Document Management & Changes
- Regulatory Affairs
- Correspondence & Commitment Tracking, Biological Deviation Reports,
Corporate Solutions
- Environmental, Health & Safety
- Incidents, Risk Assessments, Audits & Inspections, Process Safety Management, Occupational Health & Safety
- IT Service Management
- Change Control, Incident & Problem Management, Project & Action Item Tracking
- HR Management
- Grievances & Complaints, Applicant Tracking, Personnel Tracking
- Governance, Risk & Compliance
- Internal Assessments, Incidents & Investigations, Change Management, Corrective Actions
- Action Item Tracking
