Design Control
The FDA [21 CFR 820.30] and ISO 13485 mandate design control. When set up early and used correctly it saves time and money. Give us a call to find out how.
- Customized systems for this FDA- and EU–mandated activity
- Integrated with project management
- Integrated with document control
- Traceability for product decisions and rationales
- System management
- Training
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
- Experiment protocols
- Spreadsheets for data capture and analysis
- Product design specifications
- Design verification protocols and reports
- Reports to support product claims to regulatory agencies
- Traceability Matrices, Technical Files, Design Dossiers, Manuscripts
- Clinical Trials
- Protocol design, case report forms, informed consent
- Data analyses
- Clinical reports
- Investigator Brochures
- Manufacturing
- 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
- Material Safety Data Sheets [MSDS]
- Quality Assurance
- Development of customized Quality System Manual
- Customized scalable Quality System Procedures
- Risk assessments/hazard analyses
- Test methods, data capture
- Test method validation reports
- Design and Device History Files
- Device Master Records
- Traceability Matrices
- Product Certificates of Analysis
- Marketing
- Customer requirements
- System specifications
- Design validation protocols and reports
- Product labeling
- Website content
- Technical Support notes
- Research and Development