Quality Management CAPA System for the Medical Device Industry

Medical Device manufacturers must comply with good manufacturing practices set forth in the Quality System Regulation (21 CFR part 820), ISO standards 9001 and 13485, and industry best practices. The quality system regulation requires that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States.

Furthermore, the regulation requires that devices be designed and manufactured under the guidelines of the quality system and that quality data is analyzed to identify and correct quality problems, and that complaints be investigated and trended to identify systematic quality issues.

The quality system should be an integrated effort and a total systems approach to satisfy the particular safety and performance needs of a specific manufacturer, product, and user market. Using paper-based forms, disconnected systems, or manual processes to manage, track and report on quality issues and actions does not provide an effective solution for implementing harmonized, enterprise quality management processes aligned with industry best practices.

TrackWise Enterprise Quality Management CAPA Software

TrackWise, a 21 CFR Part 11 compliant solution enables your organization to ensure compliance, improve quality and reduce costs by centralizing and integrating all quality processes, including management and reporting of nonconformance, 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.

TrackWise provides the unique capability to manage all issues, actions, and changes in a centralized and integrated system. Automated workflow and configurable business rules ensure processes are followed, while enterprise reporting provides reliable information upon request to support decision-making and improve cycle times.

Medical device manufacturers have turned to Sparta Systems' TrackWise CAPA software as their solution for enterprise quality management. Customers have consistently passed FDA audits and the European Medicines Agency (EMEA) has selected and implemented TrackWise as its own QMS.

Benefits

Ensure compliance with 21 CFR Part 11, 21 CFR Part 820, and ISO standards 9001 and 13485.
Integrate complaint handling, root cause analysis and CAPA into a closed-loop quality system consistent with FDA thinking and industry best practices
Implement a best-of-breed quality management that integrates with ERP and MES systems.
Maintain high quality levels while conducting operations across outsourced sites and supply chain partners.
Reduce costs incurred by re-works, scrap, and process down times.
Increase product quality and support efforts to enhance brand equity.
Reduce cycle time and increase time to market.
Adapt quickly to manufacturing changes and reduce time-to-market.

View "Key Advantages of a TrackWise Enterprise 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.