GXP (GMP, GLP, GCP) Compliance

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Traditionally, homegrown systems, stand-alone applications, or even manual paper-based system have been used to manage quality at departmental level. Such point-solutions fail to address systemic quality problems because they lack a broad enterprise reach. In addition, such point solutions cannot scale well significantly raising the cost of compliance and increasing the risk of non-compliance with FDA's GXP regulations.

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MetricStream enables companies to take a risk-based approach to compliance and quality management as companies gain real-time visibility into the quality and document management process and its key performance metrics.

MetricStream's advanced and comprehensive suite of software solutions for automating GXP (GCP, GLP or GMP) compliance processes has embedded best practices that ensure ongoing compliance with FDA regulations. By improving operational efficiencies in quality systems, MetricStream lowers the cost of regulatory compliance and creates a transparent environment for proactively identifying, tracking and resolving quality issues.

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MetricStream solutions are widely being used in the life science industry for supporting key processes and requirements for 21 CFR Part 11, Part 210-211, Part 820 / QSR, Part 606, ICH Q7A compliance such as:

Closed Loop Processes: Ensuring that all quality processes are well integrated to create a unified and seamless environment for quality related issues and data. MetricStream solution tracks events as they move from one stage to the next, even across departments and groups, to ensure a closed loop quality management process. For instance, a document change can initiate a training request and CAPAs triggered as a result of audit findings are tied to the audit.

Streamlined Corrective Actions: Engaging teams to collaborate on development and implementation of corrective action plans. MetricStream enables triggering CAPAs, performing root cause analysis, assigning follow up actions while effectively tracking and routing cases from initiation to closure.

Efficient Audit Management: Conducting frequent internal audits to ensure that the established product and processes quality requirements are being followed. MetricStream provides capabilities to efficiently plan, schedule and conduct audits, allows audit findings to be reviewed and analyzed by a team, enables initiation of follow-up activities such as corrective/preventive actions when needed, and provides the ability to monitor the entire process.

Implementing Document Control: Streamlining document management and control processes for documents such as SOPs, batch records, regulatory filing, and quality reports. MetricStream enables companies to adopt an electronic and automated approach to managing and control documents across the enterprise with a centralized repository and tools for collaboration.

Tracking Nonconformance and Deviation: Accelerating nonconformance and deviation review and approval cycles with automated workflow. MetricStream supports recording and automatic rule-based routing of nonconformance issues for review, disposition, and closure.

Real-Time Reporting: Tracking quality issue and processes in real-time on executive dashboards and reports for data driven decision-making. MetricStream provides complete visibility into quality system database with comprehensive aggregate reporting as well as individual case status tracking. Graphical executive dashboards and flexible reports with drill-down capability provide statistics, analytics and trending.