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Posts Categorized: Regulatory

Data Integrity – Quality and Regulatory Compliance

Posted 7:26 pm by admin & filed under Industry Trends, Quality, Regulatory.

Data Integrity - Ensuring companies maintain Quality and Regulatory Compliance

Data Integrity is not a new issue; indeed, it has been part of WHO, FDA and MHRA guidelines for many years. However, recently, the major regulatory agencies have sought to reinforce the importance of Data Integrity (DI), issuing further guidance and auditing accordingly. It is not just an “India and China” issue where most FDA… Read more »

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Verta Life Sciences
  • Home
  • Consulting Services
    • Product Development
      • Pharmaceutical Development
        • Chemical Development
        • Formulation Development
        • Analytical Method Development
      • Medical Device Design
      • Design for Manufacture (QbD)
      • Quality Risk Management
      • Stability Support
      • Clinical Supply Management
      • CMC Regulatory
    • New Product Introduction & Commercialization
      • Manufacturing & Supply Strategy
      • Capacity Planning & Analysis
      • Cost of Good Analysis
      • Forecast Demand Assessments
      • Contract Manufacturing Organization (CMO)
      • Technical Transfer
      • Risk Reviews & Risk Management
      • Process Optimization
      • Pack & Artwork Design
    • Manufacturing Process
      • Process Improvement & Process Technology
      • Risk Reviews & Risk Management
      • Process Optimization
      • Lean Six Sigma
      • Technical Support
      • Quality By Design (QbD)
      • Design of Experiments (DOE)
    • Advance Manufacturing Capability
      • Capacity Planning
      • Facility Strategy
      • Facility Construction Project Management
      • Equipment Selection & Qualification
      • New Site Start-up
      • Site Sales & Closures
    • Quality & Regulatory Compliance
      • Quality Management System Design & Implementation
      • Compliance Auditing
      • QA Management & Support
      • Remediation Management & Support
      • CAPA process Improvements
      • Computer System Compliance
      • Change control management
    • Manufacturing & Supply Chain
      • Contract Manufacture Selection & Management
      • Supply Chain Management
      • Logistics Service Provider (LSP)
      • Inventory Strategy & Working Capital Management
      • Transportation Management
      • Import / Export Compliance
    • Project & program Management
      • Program and Project Management
      • Change Management
    • Mergers and Acquisitions
      • Due Diligence reviews
      • Integration Management
      • Contract Manufacture Selection & Management
      • Tech Transfer Management
      • Change Management
    • Value Optimization & Marketing
      • Market sizing & assessments
      • Marketing Campaign development
      • RX & OTC Market Analysis & Support
  • Product Management
  • Case Studies
  • Contact Us
  • About Us
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    • Our History
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