FDA GXP Compliance

The FDA initiative "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach" concerns the regulation of pharmaceutical manufacturing and product quality with an aim to focus GMP enforcement on high-risk products. The initiative aims at encouraging the adoption of modern and innovative manufacturing technology, as well as the development of consistent and predictable policies for ensuring drug quality and safety. A similar approach is being adopted in other FDA regulated industries such as medical devices and biotechnology, as well as laboratory (GLP) and clinical environments (GCP).

Traditionally, in-house developed systems, stand-alone applications, and manual paper-based processes have been used to manage quality and compliance at the departmental level. Such systems and processes lack a broad enterprise reach, are unable to scale effectively, raise the cost of compliance, and increase the risk of non-compliance with FDA's GXP regulations.

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MetricStream FDA GXP Compliance Management Software Solution

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

The solution automates GXP compliance processes, and provides embedded best practices for ensuring ongoing compliance with FDA regulations. It also improves operational efficiencies in quality systems, thereby lowering the cost of regulatory compliance. In addition, it facilitates a transparent environment for proactively identifying, tracking, and resolving quality issues.

MetricStream uniquely combines software and content to deliver solutions for effective and sustainable FDA GXP compliance. The solution also offers access to training content from an expert community, and enables integration of business processes with regulatory notifications or industry alerts.

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