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Sparta Systems Inc.

FDA Compliance

Product News: Quality Management Software for Small Life-Science Companies

Sparta System’s SelectStart uses industry best practices for analysis, validation, and compliance

Published: Monday, August 9, 2010 - 12:50

(Sparta Systems: Holmdel, NJ) -- TrackWise SelectStart is a purpose-built quality management solution created specifically for small to medium-size companies across different segments of life science industries. These emerging companies have the same rigorous quality and regulatory requirements as multibillion dollar organizations but don’t have the same resources and budget. They face pressure to maintain the highest level of quality in every facet of their operations and must maintain compliance with a growing list of regulations, including:

• Title 21 CFR Part 11—“Electronic records and electronic signatures”

• ISO 9001—“Quality management systems—Requirements”

• ICH E8—“General considerations for clinical trials”

• Title 21 CFR Part 803—“Medical device reporting”

• Title 21 CFR Part 820—“Quality system regulation”

• 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 Part 210—“Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general”

• Title 21 CFR Part 211—“Current good manufacturing practice for finished pharmaceuticals” 

• ISO/TR 14969—“Medical devices QMS—Guidance on the application of ISO 13485”

• Title 21 CFR Part 58—“Good laboratory practice for nonclinical laboratory studies”

 

Leveraging more than 15 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, SelectStart helps companies jumpstart or expand their quality management implementations with an affordable, easy-to-deploy solution. A choice of preconfigured processes is included with every SelectStart package. TrackWise validation documentation include IQ/OQ/PQs, and prebuilt and configurable crystal reports.

Companies can mix and match fast deployment process groups, enabling them to expand as their business grows. Features and benefits include:

• A simple, intuitive interface for rapid end-user adoption

• Consolidated reports and analysis for 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 prewritten validation documentation

• A closed-loop system to meet compliance mandates

• Project accelerators to shorten implementation timelines, speed deployment, and decrease time to value

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About The Author

Sparta Systems Inc.’s picture

Sparta Systems Inc.

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 subsidiary, Sparta Systems Europe Ltd.

Visit www.spartasystems.com.