Covidien, Formerly Tyco Healthcare, Selects MetricStream to Streamline Compliance Processes

Solution to automate key business processes for FDA cGMP regulations and guidelines
July 18, 2007 | Redwood Shores, CA - MetricStream, Inc., the market leader in enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management solutions today announced that Covidien (NYSE: COV, BSX: COV) has selected the MetricStream solution to automate its compliance processes for meeting FDA cGMP regulations. Covidien, formerly known as Tyco Healthcare, was recently spun off from Tyco International (NYSE: TYC; BSX: TYC) and is making its debut as an independent diversified healthcare products company boasting a diverse portfolio of innovative, market-leading healthcare products.

Covidien will deploy MetricStream's solutions for managing its product and process related non-conformances, for issue investigations and reporting, for managing controlled documents, for developing and executing corrective and preventive action (CAPA) plans, for managing change control, and managing audits. Automation of these key business processes on an integrated compliance platform will enable Covidien to improve operational efficiencies, lower the cost of regulatory compliance and create a transparent environment for proactively identifying, tracking and resolving quality issues. The system will be compliant with FDA 21 CFR Part 11 requirements for electronic records and information systems. The solution is being deployed within Covidien's Mallinckrodt pharmaceutical and imaging divisions.
Covidien manufactures, distributes and services an extensive product line that includes disposable medical supplies, monitoring equipment, surgical devices, medical instruments and bulk analgesic pharmaceuticals. With industry-leading brand names such as AutoSuture, Kendall, Mallinckrodt, Nellcor, Puritan Bennett, Syneture and Valleylab, Covidien products are found in all healthcare settings.

"We are pleased that Covidien has selected our solution to streamline their key compliance processes", said Carl McCauley, Vice President of Sales at MetricStream. “Regulated companies are adopting a risk-based approach to compliance management and MetricStream provides an integrated platform for multi-regulatory compliance bringing down the cost of compliance and reducing the risk of noncompliance. This selection validates that MetricStream continues to be the preferred compliance solution for leading companies in FDA-regulated industries.”