Quality Management
Understanding, Experience, and Technology for Compliance
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Quality Management
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Combination of product proliferation, outsourced manufacturing operations, a stringent regulatory environment and rigorous customer requirements is driving Quality Managers to proactively manage their quality processes. Programs implemented at the plant or departmental level fail to address systemic quality problems as they lack a broad enterprise reach. Business performance is directly impacted as noncompliance with quality standards or industry mandates include brand erosion, loss of key customers and higher costs. Quality Managers are leveraging best practices that call for integrated processes for supplier quality, internal quality and customer quality management that provide the organization a 360-degree view of quality-related metrics, information and risks.

MetricStream for Quality Managers

  • Document operating procedures and policies
  • Track product nonconformance and process deviations
  • Record and investigate quality issues from customers
  • Implement containment, corrective, preventive actions (CAPAs)
  • Manage supplier quality and monitor supplier performance
  • Track process metrics in real-time and leverage automatic alerts
  • Ensure closed-loop processes that drive continue improvement
  • Sustain compliance with standards such as ISO 9000 and cGMPs
Related Solutions
ISO 9000 Compliance FDA GXP Compliance Internal Quality
Customer Quality   Supplier Quality Six Sigma
Complaints Management Variance & OOS Management Nonconformance & CAPA Management

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  Resources
Webinars
How to choose a Quality Management System for a FDA-regulated environment
Best practices in managing customer quality processes
How to sustain SOx Compliance at significantly lower costs
White Papers
Quality and compliance in the Pharmaceutical industry: issues and perspectives
An Overview of cGMP Policies for Quality Management
Quality and compliance in USDA regulated industries
Insights
Roadmap for compliance with 21 CFR Part 11
Automating the process of Regulatory Compliance for Medical Devices
Systems Validation for 21CFR Part 11 Compliance