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  • Integrating Compliance and Quality Electronically

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QSi System Software

For over 16 years our QSi System software has been helping our customers achieve and maintain compliance to quality management standards like ISO 9000. QSi Systems have been improved and expanded to cover other standards and regulations including automotive quality standards, environmental standards and OH&S standards.

QSi Systems has also taken into consideration our customers’ design suggestions and the new requirements of evolving standards. Based on their ease-of-use, performance and coverage of standards’ requirements, QSi Systems, with over 2000 deployments, remain today the most popular compliance management systems on the market and are the benchmark by which other compliance software products are judged.

 

Our QSi System product family includes

 

 

QSi System for Quality Management (ISO 9001:2008)

Designed specifically to meet the requirements of ISO 9001:2008, the QSi System for Quality Management helps your organization reap the benefits of ISO certification, including improved customer satisfaction and reduced costs.

 

With this integrated product, create a seamless, paper-free Quality Management Systems across the enterprise for managing every aspect of compliance with ISO 9001 and a number of industry standards and government regulations. Functions include:

QSi System for Quality Management/Automotive (ISO/TS 16949:2002)

Realize the benefits of ISO/TS 16949:2002 certification. QSi System for Quality Management/Automotive helps companies in the automotive industry achieve compliance while improving customer satisfaction and lowering costs. Create a comprehensive quality system for managing all aspects of automotive quality. In addition to the core functionality found in the QSi System for Quality Management, the following functions are also included:

  • Business Plan
  • Contingency Plans
  • Automotive Process Change Management
  • Gage R&R
  • APQP
  • FMEA
  • PPAP
  • Transportation Carrier Performance
  • Customer Survey

QSi System for Environmental Management (ISO 140001:2004)

QSi System for Environmental Management fosters compliance with a range of standards, including ISO 14001. Improve environmental record-keeping standards, correct environmental issues, and promote a safer, more positive workplace. This flexible compliance management software addresses all aspects of environmental management. In addition to the core functionality found in the QSi System for Quality Management, the following functions are also included:

  • MSDS/HAZMAT
  • Emergency Preparedness
  • Legal Register
  • EMS Aspects and Impacts
  • EMS Targets and Objectives
  • EMS Monitoring
  • EMS Policy Manual

QSi System for Occupational, Health & Safety Management (BSI OHSAS 18001:1999)

QSi System for Occupational Health and Safety management streamlines compliance with regulations like OHSAS 18001, BS8800, and ANSI/AIHA Z10-2005. With this software, create the complete occupational, health and safety system. Track and address workplace incidents, sharpen emergency preparedness and response, and effectively manage your policies and records. Minimize risk to employees while enhancing your organization’s image in the community and in the marketplace. In addition to the core functionality found in the QSi System for Quality Management, the following functions are also included:

  • Accident and Incident Reporting
  • Chemical and Risk Assessment
  • Claims Management
  • OH&S Policy Manual
  • Emergency Preparedness
  • MSDS/HAZMAT
  • Monitoring and Test Records
  • Legal Register

QSi System for FDA Document Control & CAPA (21 CFR Part 11)

QSi System for FDA Document Control is purpose-built to address FDA requirements. In accordance with the requirements of FDA 21 CFR Part 11, the QSi System for FDA Document Control requires the use of dual passwords for all document reviewers and approvers with password sizes and time-outs selectable by the system Password Administrator. An optional Draft Documents area automatically provides an audit trail that records time-sequenced development and modification of documents.

 

The QSi System for FDA Document Control provides users with flexible serial or parallel workflow options for reviewing and approving documents. Every released document is automatically archived and stored. Users can define the release dates for approved documents to allow for training.

 

Features include:

  • Automated alpha or numeric choices for document versioning.
  • Document review and auditing schedule.
  • Automated status tracking for each document and template.
  • Automatic email notifications and distribution of documents upon approval.
  • Automatic updating of training records prior to document release.
  • Audit trail documenting time-sequenced development and modification of documents.
  • Electronic signatures automatically record date, time and time zone.

QSi Reports

Purpose-built to satisfy the most stringent reporting requirements, QSi Reports provides your organization the foundation it needs to demonstrate and manage the process of continual improvement.

 

This reporting tool gives you fast, intuitive access to your data, powerful ad hoc analysis and reliable reports that will enable you to make better decisions faster. These graphs and charts simplify the presentation of complex data and highlight important trends and exceptional conditions for real time business information.

 

Features include:

  • Over 140 predefined reports
  • Online analytical processing (OLAP) with 2,800 drill-down options with graphics designed for the QSi System product family
  • Multiple user network accessibility
  • Spreadsheet integration
  • Ability to view, create and modify interactive data reports
  • Easy formatting of data into line, bar or bar charts, histograms, Pareto Charts as well as basic tables