Quality Management System

GMP requirements (2l CFR parts 210 and 211), ISO standards, and industry best practices require pharmaceutical and biotechnology manufacturers, contract research organizations, and lab services organizations to implement reliable quality management systems. FDA's Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations (September 2006) calls for a "comprehensive quality systems (QS) model" which integrates various aspects of the quality, manufacturing, and risk management using a holistic approach. Similar expectations are required of other national and international regulatory bodies and health authorities.

Using paper-based forms, disconnected systems, or manual processes to manage, track and report on quality issues and actions does not provide effective solutions for implementing harmonized, enterprise quality management processes, which follow industry best practices.

TrackWise Enterprise Quality Management Software

Hundreds of pharmaceutical and biotechnology companies have turned to Sparta Systems' TrackWise software as their solution for enterprise quality management. TrackWise enables your organization to ensure compliance, improve quality and reduce costs by centralizing and integrating all quality processes, including management and reporting of deviations, 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.

TrackWise has been validated in over 100 pharmaceutical and biotechnology companies as a 21 CFR Part 11 compliant solution, and has enabled many of these to companies remediate quality system deficiencies cited in 483s, warning letters, and consent decrees.

Benefits

Ensure compliance with 21 CFR Part 11, 21 CFR Part 210, 211, and ISO standards
Implement a closed-loop quality system consistent with FDA thinking and industry best practices
Implement best-of-breed quality management while integrating to ERP and MES systems
Maintain high quality levels while conducting manufacturing 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.