FDA GXP (GMP, GCP, GLP) Compliance

The FDA initiatives "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. It aims at encouraging the adoption of modern and innovative manufacturing technology, and to develop consistent and predictable policies for ensuring drug quality and safety. Similar approach is being adopted in other FDA regulated industries like medical devices and biotechnology as well as for laboratory (GLP) and clinical environments (GCP).

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

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

MetricStream's advanced and comprehensive suite of solutions for automating GXP 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.

MetricStream uniquely combines software and content to deliver solutions for effective and sustainable compliance with embedded best practices templates, access to training content from an expert community, and integration of business processes with regulatory notifications or industry alerts.

Related Products Compliance Management Risk Management Document Management   Issue Management CAPA / Remediation Audit Management Training Management   Regulatory Reporting Change Management Equipment Management more ...

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.