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Design Control & Documentation

Design Control

The U. S. FDA & ISO 13485 mandates design control. When set up early and used correctly design control saves time and money. Give us a call to find out how.

Customized systems
Integrated with project management
Integrated with document control
Traceability for product decisions and rationales
System management
Training

Meeting management

Documentation

Documentation is the lifeblood of any biotechnology company. Early implementation of document control speeds product development and agency clearance to market.

Customized document systems integrated with project management and design control
We write/review documents for:
  • Research and Development
    • SOP, worksheets
    • Experiment design protocols
    • Spreadsheets for data capture and analysis
    • Assay product specifications
    • Design verification protocols and reports
    • R & D Reports
    • Traceability Matrices & Scientific Manuscripts
 
  • Clinical Trials
    • Clinical study plans
    • Protocol design, case report forms
    • Data capture, statistical analysis, reports
    • Investigator Brochures
    • Training modules
    • IRB/EC documentation
    • Informed consent forms
    • EU Clinical Evaluation reports (Literature Searche)
 
  • Manufacturing
    • Prelimanary manufacturing plans
    • Device Master Records
    • Bills of Materials
    • Raw material, component, in-process and final test specifications
    • Equipment validation protocols and reports
    • Process design, verification, and validation protocols and reports
    • Production SOP, data capture
 
  • Quality Assurance
    • QA Manuals, Quality System procedures
    • Risk assessment/hazard analysis
    • Test methods, data capture
    • Test method validation reports
    • Design and Device History Files
    • Device Master Records
    • Traceability Matrices
    • Product Certificates of Analysis
    • Phase VI Product Performance Reviews (customer, mfg. process)
    • OEM & vendor audits, & internal compliance audits
 
  • Marketing
    • Customer requirements
    • Product specifications
    • Design validation protocols and reports
    • Product labeling
    • Website content
    • Technical Support notes
    • Sales Training modules