Quality Systems Management

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, integrated quality management processes, which follow industry best practices.

Hundreds of Pharmaceutical and biotechnology companies have turned to Novatek software as their solution for quality management. Novatek enables your organization to ensure compliance, improve quality and reduce costs by centralizing and integrating all quality processes, including management and reporting of deviations, customers compliances, suppliers quality, internal and external audits, change control, corrective and preventive actions (CAPA), Preventive maintenance and calibration, training management, document management and others.

Novatek 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 reporting provides reliable information upon request to support decision-making and improves cycle times.

Benefits:

Ensure compliance with 21 CFR Part 11, 21 CFR Part 210, 211 and ISO Standard
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

Key Advantages of a Quality Management System
NOVATEK provides a robust architecture to support your organization's integrated quality management needs by providing:

Risk Reduction
NOVATEK 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.

Integration to Key Systems
NOVATEK integrates seamlessly with other systems including ERP, Document Management, LIMS, MES and others, via its out-of-the box NOVATEK 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.

Reporting
NOVATEK is the only quality management software on the market that provides a suite of 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. NOVATEK 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
NOVATEK 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.