Documentation Support

Standardized Documentation Assures Positive Results.

Documentation Expertise

Let our Professional Staff save you time and effort when preparing critical project documents. We offer expertise and templates for the development of:

 

  • Functional Specification Requirements
  • Statement of Work
  • Calibration Management System Vendor Quality System Questionnaire
  • Critical and Detailed Risk Assessments
  • Project Management
    • Project Schedule utilizing MS Project
    • Project Status Reporting
    • Manage Project Deliverables
    • Manage Cost
  • 21 CFR Part 11 Guidance
  • Validation Project Plan
  • User Requirements Specifications (URS)
  • URS/FRS Gap Analysis
  • Work Flow Development
  • Configuration Management
  • System Architecture/Data Flow Diagrams
  • System Design Specifications
  • Data Model
  • SOP Development
  • System Usage SOPs
  • Training Plan
    • Training Manual
    • Training Agenda
    • Training Outline
    • Role Based Training
    • Training Certification
  • Installation Qualification (IQ)
  • Operation Qualification (OQ)
    • Protocol and Scripts
  • Performance Qualification (PQ)
    • Protocol and Scripts
  • IQ/OQ/PQ/UAT
  • Requirements Traceability Matrix
  • Data Migration Plan
    • Data Mapping
    • Data Verification
  • Custom Reports
  • Risk Assessment
  • Master Validation Plan
  • Testing & Validation Strategy
  • Validation Summary Report

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