Data Retention Compliance

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FDA mandates that a pharmaceutical company must retain the batch records and other quality data in its original business context for a certain period of time. The SEC calls for organizations to store business documents for stipulated periods. HIPAA has a number of guidelines for document retention and security. Compliance requirements are coming from many directions and companies are quickly recognizing the increasing risks and costs of not abiding by the laws that affect data protection, retention, and security. Organizations are looking for ways to reduce the risk associated with managing growing and disparate forms of data by meeting the requirements for regulatory compliance and corporate governance.

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MetricStream Data Protection Compliance solution is a comprehensive solution to enable consistent and cost-effective management and retention of data and documents. Built on the MetricStream Enterprise Compliance Platform, the data protection compliance solution provides a robust data repository for holding operational data from systems being retired and making it accessible for audits.

Data Migration and Storage: MetricStream enables data migration based on powerful and flexible adapters called Infolets^TM that extract relevant data from retiring systems and load it in the MetricStream repository. MetricStream provides a central repository for storing and organizing the data and documents. Flexible templates and classification criteria ensure that the original format and context are preserved.

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Data Lifecycle: Review and approval process around data lifecycle are driven by workflows defined at the organizational level. Upon completion of the retention period, an approval workflow is triggered to ensure that the document and data cannot be deleted, unless the approval process is completed.

Security and Access Controls: MetricStream provides secure document access with centrally managed policy-driven controls. The system provides accurate time stamped audit trails. Electronic signatures capability based on robust authentication and authorization infrastructure ensures compliance with regulations such as FDA 21 CFR Part 11.

Reports and Metrics: MetricStream provides transparent access for authorized users to older operational data from any desktop in the organization through customized reports that show the information in its original context. In addition, graphical executive dashboards and flexible reports with drill-down capability provide statistics and data by a variety of retention parameters like document types, status, audit history, retention times, document usage summaries, etc.