Industry standards and regulations
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TMS Quality Compliance Software  is designed to automate and streamline the entire quality management process and fulfill compliance to a wide range of industry-specific standards and regulations.  Our Client Case Studies illustrate regulated industries who leverage TMS software to maximize efficiency, minimize costs and achieve regulatory compliance worldwide.
See our case studies

Food & Beverage

Food and Beverage Industry regulations and standards require organizations involved in the food chain to implement systems which ensure the safety and quality of their products.  TMS software automates and controls the processes required for compliance to those complex quality and safety initiatives.  With TMS companies can reduce the risk of recalls and other safety-related issues, streamline processes, simplify audits, increase efficiency and ultimately cut costs.

FDA sets new priorities for Food with a Final Strategic Plan. This plan highlights several goals to orient the U.S. food supply toward the following:

  • Establish Preventive Control Standards
  • Foster Collaboration
  • Provide accurate and useful information
  • Improve detection and response to foodborne outbreaks

Pharma & Life Sciences

Pharma and Life Sciences companies (e.g. pharmaceutical, biotech, medical device) operate in a demanding and highly regulated environment.  These organizations must maintain a high level of compliance with numerous regulatory requirements such as Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), FDA 21 CFR Part 11, Sarbanes-Oxley (SOX), and ISO standards. TMS software is a simplified, centralized system that offers an integrated approach for managing compliance and quality processes such as CAPAs, complaints, audits, document control and training management.

With TMS solutions companies can:

  • Minimize Risk and Liability
  • Increase Audit Readiness
  • Proactively track, identify and assess risk
  • Reduces Operational Costs
  • Achieve faster time-to-market

General Manufacturing

Manufacturing facilities must operate efficiently and minimize costs in order to compete in today’s economic environment.  They also face the demands of complying with regulations and standards such as SOX, OSHA, FDA 21 CFR 11, Good Manufacturing Practices, and ISO 9000 certifications.   TMS helps companies automate processes, foster collaboration and operate efficiently to cut through the complexities of manufacturing operations. Today’s regulatory pressure doesn’t stop with external authorities, many companies pass these standards on to their suppliers to ensure conformance and traceability throughout the supply chain. TMS helps cut through the complexities of your operations with automated features and functions to:

  • Control and streamline processes
  • Facilitate collaborative relationships
  • Improve quality and reduce risk
  • Demonstrate compliance

Government & Public Sectors

Government organizations face the difficult task of managing increasing volumes of information, securing sensitive data, and complying with various standards and regulations such as FDA, OSHA, and SOX.  TMS Quality Compliance Software provides a powerful way to control and secure the critical information in your organization. Our TMS technology helps to provide the transparency and accountability required for complex audits and regulatory compliance. TMS delivers the performance needed to stay on track, improve operations, maintain regulatory requirements and mitigate risk.

QSI’s solution enabled us to integrate all of our various functions into one centralized system and automate the process from start to finish, and it provides us a seamless depository for our internal and external audits.
John Gray, Quality Assurance Manager,  The Acquisition Management and Integration Center, a division of Langley Air Force Base

Aerospace & Aviation

Aviation quality assurance and regulatory standards are designed to ensure the effectiveness and safety of aviation operations. TMS Quality Compliance Software is an integrated solution that helps manage the technical data, vital policies and procedures, training and certifications required to achieve compliance goals and business objectives. Our TMS solution automates the processes and workflows required for managing this complex network of organizational knowledge and administrative tasks. TMS provides robust features to secure and control documents; collaboratively review documents; and monitor tasks with follow-up actions and escalation. With TMS, necessary documents are current and readily available for employees, customers, suppliers, and regulators.

The aerospace and defense industry faces numerous compliance requirements from the government and within its own internal standards of excellence. The AS 9100 is the Quality Management standard for Aviation, Space and Defense Organizations and is a requirement for doing business with these industries. The new standard places emphasis on the following:

  • Risk Management
  • Critical Items
  • Measurement of conformance
  • Adopt Proven Product Development Processes
  • Eliminate recurring CAPA (Corrective Actions)

Automotive

Companies in the automotive sector are faced with the complex challenge of evolving regulatory requirements and customer demands with an increased focus on accountability. This requires efficiency across all levels of an organization to manage quality standards and compliance activities while navigating risk and driving profitability. TMS Quality Compliance Software automates business processes to manage important policies and procedures, corrective and preventive actions, supplier-customer relations, training and certifications, inspections and audits. TMS is an integrated solution that provides document management, revision control, user-based permissions, action items with escalation, audit trails and reports, and tracking training with quizzes.

QS9000 is a quality standard developed by a joint effort of the “Big Three” American automakers. GM, Chrysler, and Ford. Suppliers to these companies are required to implement this standard which also includes the ISO 9001 Quality Management Standard. QS 9000 management requires the following:

  • Documentation and Training on the Standard
  • Organization Preparation and Team Assignment
  • Development of Quality Manual and System
  • Continual Assessment of your Quality System

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