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

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.

FDA Validation Services For ERP 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.

FDA Validation Module Protocols Include

  • Security
  • Sales Orders
  • Routings
  • Compliance
  • Quality Management
  • Inventory Control
  • Distribution Orders
  • Item-Site Master Records
  • Service & Support Management
  • Purchasing
  • Physical Inventory
  • Formulas
  • Product Change Control
  • Processes
  • Work Orders
  • Advanced Repetitive
  • Shop Floor Control
  • Product Structures
  • Item Attributes & Quality
  • eSignatures

QAD validation toolkit includes

  • Computer Software Validation Plan
  • Functional Requirements
  • Risk Analysis
  • Operational Qualification Protocol/Test Scripts
    • Distribution
    • Master Files
    • Manufacturing
  • Traceability Matrix
  • Baseline Configuration
  • Data Migration Protocol
  • Systems Stress Test Protocol
  • Final Validation Report

Markets Served

Strategic serves the spectrum of Life Sciences industry, including:

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