Quality Management System
Blood centers and blood and tissue manufactures are regulated by strict quality requirements to ensure the safety of our blood supply. Donor centers must follow quality regulations as required by American Association of Blood Banks (AABB) and blood and tissue manufacturers must follow 21 CFR Parts 600, 601, 606 and 610, as well as Good Manufacturing Practices (GMPs) required by Part 210 and 211 and ISO regulations.
The FDA has significantly increased oversight of laboratories and blood centers, with its Center for Biologics Evaluation and Research (CBER) now inspecting all facilities at least once every two years. Facilities classified as "problem facilities" are subject to inspection more frequently.
Blood centers and blood and tissue manufacturers are challenged with implementing effective quality management systems while balancing constrained budgets and limited resources.
TrackWise Enterprise Quality Management Software
Sparta Systems' TrackWise software enables blood centers and manufacturers to ensure compliance, improve quality and reduce costs by centralizing and integrating all quality processes, including management and reporting of biological product deviations (BPDs), customer complaints, supplier quality, internal and external audits, change control, corrective and preventive actions (CAPA), preventive maintenance and calibration, training management, document management and others.
Sparta Systems' TrackWise software is an ideal solution for blood establishments, as it provides an enterprise system, which can be implemented out of the box, with minimal implementation time and minimal costs. TrackWise offers:
- Pre-configured solutions out of the box
- Easy to use, point-and-click configuration tools with no need for software customization
- Industry proven validation package
- Backwards compatibility of upgrades and new releases
TrackWise has been implemented on over 150 life sciences companies, including blood centers, blood manufacturers, and in-vitro diagnostics companies, as a 21 CFR Part 11 compliant enterprise Quality Management Software system.
View "Key Advantages of a TrackWise Quality Management System"
Key Advantages of a TrackWise Quality Management System
TrackWise provides a robust architecture to support your organization's enterprise quality management needs by providing:
An Integrated Quality Systems Approach
Unlike other point-solutions, which license separate "modules" for various parts of the quality process, TrackWise manages all quality processes using one software system. Your organization benefits from a common interface and integrated workflow processes, which provide an effective closed-loop process.
|
Risk Reduction
Sparta Systems' StateMachine™ technology provides flexible data-drive workflow, which ensures compliance with standard operating procedures, eliminates manual, error-prone process steps, and reduces risk of deviations and noncompliance. Our patented 24/7 business rules engine, automates what were once manual SOPs to reduce risk of deviations.
|
Integration to Key Systems
TrackWise integrates seamlessly with other enterprise systems including ERP, Document Management, LIMS, MES and others, via its out-of-the box TrackWise Integration Manager. Real-time access to master data, and the ability to integrate quality and manufacturing processes, such as batch release, testing, and others, enables your organization to operate more efficiently and confidently.
|
Enterprise Reporting
TrackWise is the only quality management software on the market that provides a suite of enterprise reporting and trending tools. User and management dashboards, ad hoc search tools, integrated reporting, and automatic email distribution of reports enable ensure visibility, streamline processes, and reduce closure cycle time.
|
Flexibility
The success of a company's quality management system will be determined not just by the initial implementation, but also by the company's ability to enact changes easily and seamlessly. TrackWise is fully configurable to adapt to your company's specific business needs, providing flexibility, as well as scalability, to support changes to fields, forms, workflows, and business rules, and the ability to add future applications, without requiring any code changes.
|
Industry Best Practices
TrackWise is available with a pre-packaged quality management configuration that implements best practices resulting from over 100 industry implementations. The pre-configured solution accelerates implementation, lowers cost, and reduces risk by leveraging industry best practices.
|
Highest ROI
Using a single vendor and a single application reduces the number of systems to manage your quality processes as well as the associated costs. In addition, errors, omissions and repeat incidents are eliminated, operations are streamlined, and manual processes are automated, further increasing investment and productivity.
|
