News | August 9, 2010

New Quality Management Software Created Specifically For Small To Medium Size Companies

Source: Sparta Systems, Inc.

TrackWise SelectStart is a purpose-built quality management solution created specifically for small to medium size companies across different segments of life science industries. Emerging companies have the same rigorous quality and regulatory requirements as multi-billion dollar organizations, but do not have the same resources and budget. They face growing pressure to maintain the highest level of quality in every facet of their operations and must maintain compliance with a growing list of regulations:

  • Title 21 CFR Part 11 – Electronic Records and Electronic Signatures
  • ISO 9001 – Quality Management Standard
  • ISO 9000 – Quality Management Systems – Fundamentals and Vocabulary
  • ICH E8 – General Considerations for Clinical Trials
  • Title 21 CFR Part 803 – Medical Device Reporting
  • Title 21 CFR Part 820 – Quality System Regulations
  • ICH Q7A - Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • ISO 13485 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
  • ISO 14971– Medical Devices – Application of Risk Management to Medical Devices
  • Title 21 CFR Parts 210 and 211 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs
  • ISO/TR 14969 – Medical Devices – Quality Management Systems – Guidance on the Application of ISO 13485
  • Title 21 CFR Part 58 – Good Laboratory Practice for Nonclinical Laboratory Studies

Leveraging more than fifteen years of industry expertise, Sparta Systems has developed a turnkey solution with a dedicated support team to help small and medium sized companies quickly and affordably deploy a quality management solution. TrackWise SelectStart delivers a preconfigured solution that meets the quality and compliance needs of emerging growth companies.

Combining the strength of the company's experience and the breadth of the TrackWise solution, Sparta Systems developed SelectStart, a solution tailored to the needs of small and medium sized companies to help them jumpstart or expand their quality management implementations with an affordable, easy to deploy solution. Included with every TrackWise SelectStart Solution package is a choice of preconfigured processes to select from, TrackWise validation documentation including IQ/OQ/PQs and prebuilt and configurable Crystal Reports.

Companies can mix and match fast deployment process groups, enabling you to expand as your business grows.

Features & Benefits

  • A simple, intuitive interface ensures rapid end-user adoption
  • Consolidated reports and analysis provides insightful view of captured data
  • Industry best practices to drive quality and compliance efficiencies
  • A seamless avenue for enterprise growth using the TrackWise platform
  • Reduced validation efforts using pre-written validation documentation
  • A closed loop system to meet compliance mandates
  • Project accelerators to shorten implementation timelines, speed deployment and decrease time to value

SOURCE: Sparta Systems, Inc.