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FDA Validation Toolkit

Our Validation Protocols Toolkit for QAD ERP can be used on your own or combined with Strategic Professional Services.

Validation Services Include:

  • Documentation Development
  • Installation Qualification (IQ) Protocols
  • Operational Qualification (OQ) Protocols
  • Performance Qualification (PQ) Protocols
  • Software Validation Master Plan (SVMP) Development
  • 21 CFR Part 11 Compliance Services
  • Functional requirements
  • Traceability Matrix
  • Risk Analysis
  • Final report with conclusions & recommendations

The protocols assist you with providing documented verification that all key aspects of the software were installed, and that they operate and perform in accordance to QAD design requirements.

Validation Module Protocols Include:

  • Security
  • Sales Orders
  • Routes / Work Centers
  • Compliance
  • Quality Management
  • Inventory Control
  • Distribution Orders - Supply Chain
  • Item / Site Maintenance
  • Purchasing
  • Physical Inventory
  • Formulas
  • Product Change Control
  • Processes
  • Work Orders / Shop Floor Control
  • Service and Support Management
  • Product Structures

Markets Served
Strategic serves the spectrum of Life Sciences industry, including:

  • Pharmaceutical companies
  • Medical device companies
  • Nutraceuticals
  • Biotechnology companies

Our clients have included drug and vaccine developers, generic houses, hospital equipment manufacturers, contract sales organizations, engineering companies, fulfillment companies, clinical research, device manufacturers (including implantables) and control system manufacturers.

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