Founded in 1994, Sparta Systems, Inc. is the leading provider of enterprise quality management software. In addition to its U.S. operations, the company provides sales and services to Europe, Asia and Australia through its subsidiaries, Sparta Systems Europe, Ltd. and Sparta Systems Asia.
Our vision is that all business organizations will benefit from using a versatile, powerful and configurable management, tracking and reporting system. With this in mind, Sparta developed TrackWise®, first released in 1995. Below is a list of their white papers and analyst reports that are available. Please contact Sparta Systems if you would like to receive any of the following:
White Papers & Analyst Reports
Addressing the Challenges of Complaint Handling, Investigations and Adverse Event Reporting
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. Furthermore, as the globe's dependence on medicine continues to heighten, as does the trend toward pervasive personalized medicine, the quality reigns are getting harder for many firms to hold on to. 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.
EQMS Coexistence in an Enterprise Environment
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 pressure is further compounded by the current economic climate, in which companies face constant demand to drive cost out of operations by eliminating redundant technology and supporting infrastructure. It is imperative that the most effective decisions be made when reviewing alternate solution approaches to ensure that both the necessity of quality and the highly sought-after economic efficiencies are realized to the greatest extent possible.
Issues Facing Device Manufacturers as FDA Moves Closer to Mandating Electronic Reporting (eMDR)
Transitioning from a paper-based system to an electronic reporting platform will require thought, planning, design, testing, and implementation. The purpose of this paper is to help identify many issues which will emerge during the transition process. In this discussion, emphasis is placed on careful upfront thought and planning. Thorough work on these fronts will ensure a smooth design phase, productive testing, and a successful implementation.
Food and Beverage Manufacturers: Avoid TREAD Act Déjà Vu and get a Grip on Quality Now
The recent food recalls have intensified the focus on product quality from the supplier, to the shop floor, to the boardroom. In a recent study of 90 food and beverage companies on quality management strategies and architecture, AMR Research found significant business process performance hurdles, with data analysis and corrective and preventive actions (CAPAs) being the most glaring gaps.
Technology Approaches to Quality Management
The presence of software solutions in the quality arena has progressed gradually from a deployment of tactical point solutions to complete, enterprise-level solution offerings.
Aberdeen Report: The Cost of Quality Benchmarking Enterprise Quality Management
The process of quality management has evolved significantly over the past several years.
Creating a Culture of Quality
For years, the manufacturing industry has been in the midst of a struggle between two opposing forces – supply chain management and supply quality management.
Enterprise-Level Change Control: A Life Science Business Imperative
Change control in life science organizations is a critical business issue in terms of risk, safety and business performance - and it cannot be short-changed.
Why CAPA Still Matters
Many organizations have yet to adopt an effective closed-loop CAPA management process, and even fewer have implemented a consolidated system for addressing the quality of the processes in place to track and report CAPA issues
SOURCE: Sparta Systems, Inc.