Profile

This Health Care Product Manufacturer (HCPM) makes and sells a variety of products for consumers, life sciences researchers, and health care providers. One product line includes glucose monitors and disposable testing strips, and other diabetes care products for people managing that disease.

Need

The company uses SAS-based software applications to test strip lots and create meter calibration data used for quality assessment and reporting. The applications were decentralized, causing duplication of reports, rising application deployment and maintenance costs, and labor-intensive efforts to ensure 21 CFR Part 11 compliance. HCPM had plans to launch a new product to replace the old product line of glucose monitoring systems. The company needed a centralized, integrated, FDA-compliant solution for managing, analyzing, and reporting the calibration data for the new product.

Outcome

Pinnacle Solutions designed, developed, and implemented a system which delivers the calibration data and reports HCPM needs in a compliant and cost-effective fashion. The new application now resides in a single, secured environment. The SAS Enterprise Business Intelligence suite anchors the application’s analytic engine, and a document management system stores output in a globally-accessible secure environment. Audit trails for all transactions and version control of all data, programs, and output are maintained automatically.

Benefits

  • 21 CFR Part 11 compliance
  • Global access to data
  • Controlled costs
  • Centralized & searchable repository
  • Enhanced efficiency and productivity

Related Services

SAS is a registered trademark of SAS Institute Inc. in the United States and/or other countries.

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