FDA Compliance
Sustain compliance with systematic and repeatable processes

 

FDA Compliance Solution

Companies in pharmaceutical, biotechnology, and medical devices industries are constantly pushing the boundary of innovation to develop new products. They are also challenged to meet the rising standards of quality, and comply with rigorous regulatory requirements.

Most companies use homegrown systems, stand-alone applications, or manual paper-based systems to manage quality and compliance. However, such systems cannot scale effectively or reach across the enterprise. This significantly raises the cost of compliance, and increases the risk of non-compliance with FDA regulations.

MetricStream FDA Compliance Management Solution

MetricStream provides a common framework and an integrated approach to meet FDA regulations. The solution enables companies to adopt a risk-based approach to quality and compliance management. It also strengthens FDA compliance through advanced capabilities for risk management, document control, compliance training, ongoing auditing, and recording and reporting of exception events and the resulting corrective actions.

MetricStream's advanced and comprehensive FDA regulatory compliance software automates GXP compliance processes, and provides embedded best practices that ensure ongoing compliance with FDA regulations. The solution improves operational efficiencies in quality systems, lowers the cost of regulatory compliance, and enables complete transparency for proactively identifying, tracking, and resolving quality issues.

The solution uniquely combines software and content for effective and sustainable compliance. Embedded best practice templates, access to expert training content, and integration of business processes with regulatory notifications or industry alerts enable organizations to drive optimum value from FDA compliance.

MetricStream FDA Compliance Solutions is being widely used in the life sciences industry for supporting compliance with 21 CFR Part 11, Part 210-211, Part 820 / QSR, Part 606, and ICH Q7A.

Benefits of the MetricStream Solution

Closed Loop Processes: The MetricStream solution integrates all quality processes to create a unified and seamless quality management environment. The solution tracks events from one stage to the other to ensure closed-loop quality management. Training requests can be triggered from document changes, and CAPAs from audit findings.

Streamlined Corrective Actions: The MetricStream solution enables teams to collaborate seamlessly on CAPAs, root cause analyses, follow-up action assignments, and effective tracking and routing of cases from initiation to closure.

Efficient Audit Management: The solution provides capabilities to efficiently plan, schedule, and conduct FDA compliance audits, allow audit findings to be reviewed and analyzed, initiate follow-up activities such as corrective/preventive actions, and monitor the entire process.

Document Control:The MetricStream solution enables companies to adopt an electronic, streamlined, and automated approach to managing and controlling enterprise-wide documents such as SOPs, batch records, regulatory filings, and quality reports.

Non-conformance and Deviation Tracking: The MetricStream solution accelerates non-conformance management by recording and automatically routing non-conformance and deviation issues for review, approval, and closure.

Real-time Reporting: The MetricStream solution provides complete real-time visibility into quality management with comprehensive aggregate reporting as well as individual case status tracking. Graphical executive dashboards and flexible reports with drill-down capabilities provide statistics, analytics, and trending information, enabling stronger decision-making.