Regulatory Articles

  1. White Paper: ERP, Document Management & Other Enterprise Applications — Can They Fulfill The Quality Mission Alone? 12/3/2010
    Quality and IT executives alike face increasing pressure to implement solutions that allow the highest level of holistic control and oversight on the quality of their operations. This paper sets out to explore macro-level trends in both the ERP and quality systems application spaces, as well as discuss key issues that should be considered by those currently faced with this question.
  2. Enterprise Level Change Control: A Life Sciences Business Imperative 10/21/2010
    Drug and medical-device manufacturers spend hundreds of millions of dollars to gain regulatory approval for their new therapies and therefore require significant returns just to break even. By Sparta Systems, Inc.
  3. White Paper: Enterprise Level Change Control: A Life Sciences Business Imperative 10/21/2010
    Drug and medical-device manufacturers spend hundreds of millions of dollars to gain regulatory approval for their new therapies and therefore require significant returns just to break even. When internal or external forces challenge production standards, related processes, specifications or even critical documentation, controls must be put in place to ensure that product quality is not compromised. By Sparta Systems, Inc.
  4. Addressing The Challenges Of Complaint Handling, Investigations, And Adverse Event Reporting 10/21/2010
    Quality is an ever-growing problem in the fields of pharmaceutical, medical devices, medical diagnostics and biologics, and its negative impact is signifi cantly palpable to manufacturers as well as their patients, employees and investors. By Sparta Systems, Inc.
  5. White Paper: Addressing The Challenges Of Complaint Handling, Investigations, And Adverse Event Reporting 10/21/2010
    Quality is an ever-growing problem in the fields of pharmaceutical, medical devices, medical diagnostics, and biologics, and its negative impact is significantly palpable to manufacturers as well as their patients, employees and investors. While some of this is due to poor products, a large amount can be attributed to inadequate quality reporting infrastructure on behalf of the manufacturers. By Sparta Systems, Inc.
  6. Creating A Culture Of Quality In The Manufacturing Industry 10/21/2010
    For years, the manufacturing industry has been in the midst of a struggle between two opposing forces – supply chain management and supply quality management. The quality of manufacturing must be linked directly to the effi ciency in the supply chain – so that products are manufactured quickly and eff ectively. By Sparta Systems, Inc.
  7. White Paper: Creating A Culture Of Quality In The Manufacturing Industry 10/21/2010
    For years, the manufacturing industry has been in the midst of a struggle between two opposing forces – supply chain management and supply quality management. The quality of manufacturing must be linked directly to the efficiency in the supply chain – so that products are manufactured quickly and effectively. By Sparta Systems, Inc.
  8. Sparta Systems Success Story: Invacare Streamlines Complaint Management To Improve Customer Service Levels Worldwide 7/28/2010
    Sparta Systems TrackWise solution enables Invacare to harmonize the complaint intake and investigation process globally, consolidating redundant systems, reducing manual operations, and reducing costs. By Sparta Systems, Inc.
  9. Sparta Systems Success Story: Invacare Streamlines Complaint Management To Improve Customer Service Levels Worldwide 7/28/2010
    Sparta Systems’ TrackWise solution enables Invacare to harmonize the complaint intake and investigation process globally, consolidating redundant systems, reducing manual operations and reducing costs. By Sparta Systems, Inc.
  10. EQMS Coexistence In An Enterprise Environment 6/17/2010
    Quality and IT executives alike face increasing pressure to implement solutions that allow the highest level of holistic control and oversight on the quality of their operations. By Sparta Systems, Inc.