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Industry Notes

January 4, 2006

MasterControl Rolls Out Compliance Tool

MasterControl has introduced a solution designed to help FDA-regulated and ISO-conforming companies automate, streamline and effectively manage the quality audit process. In the FDA and ISO environments, audits are required to maintain a self-correcting quality system that will help guarantee product quality and safety. The MasterControl Audit solution is designed to help companies establish and maintain a compliant audit program to meet the requirements of different types of quality audits: internal, supplier/customer and regulatory. MasterControl Audit integrates the different steps (preparation, scheduling, execution, findings, verification and completion) in the audit process. It provides:

A secure and centralized web-based repository of all audit documentation that makes search and retrieval easy; Advanced tracking capability every step of the way. The system automates task assignment and follow-up via automatic email notification. It incorporates escalation capability for overdue tasks; Best-practice audit forms for collecting and tracking data throughout the audit process; An audit summary form that is essential in planning and starting an audit. It tracks basic information, such as type of audit, date, description, objective, scope, audit area and lead auditor; and An audit finding form, which tracks all the findings resulting from the audit. It integrates risk management by providing a section for evaluating risks and gathering the following information: risk category, severity, risk of recurrence, and whether CAPA is required. It also ensures proper closure by tracking verification of the process owner's response to the finding.

For more information, visit www.mastercontrol.com (http://www.mastercontrol.com), or call 800-825-9117.

Partners Team for Email Archiving Tool

Imation and its partners Intradyn and Exabyte have unveiled what they call the industry's first VXA and LTO-enabled ComplianceVault email archiving appliance, a completely integrated hardware and software solution that archives businesses' email messages on a continuous basis, from a virtually unlimited number of mailboxes.

When the Imation ComplianceVault solution is connected to an organization's network, all email messages are immediately and continuously saved and indexed to disk, in addition to being archived and indexed to tape at intervals specific to the needs of the company, the partners said last month. The appliance is a complete, bundled solution with a single upfront cost, unlike competitive offerings that require customers to pay ongoing per-user license fees and software maintenance costs.

The ComplianceVault system is compatible with Microsoft Exchange, Lotus Notes and virtually any IMAP or POP3 email system, allowing companies to meet a variety of email archiving needs, whether for regulatory compliance -- including Part 11 -- for legal ediscovery, or simply for good business practice in erecords management. The Imation ComplianceVault appliance is available in several capacities ranging from 320GB to 1TB of disk storage and in two tape backup formats, VXA and LTO Ultrium(TM) systems, including LTO Ultrium 3 with WORM capability.

For more information, go to http://www.imation.com/compliancevault (http://www.imation.com/compliancevault).