Prior to Production Startup
Design and Validation
Our
validation specialists have expertise based on education and extensive
experience validating all types of computer systems and equipment. Our
experts can work with your documentation standards or can provide proven
document solutions to meet your needs and all FDA requirements. 
- Functional
Requirements
- System Specifications
- Structure Tests
- System Simulation
and/or Emulation
- I/O Check-Out
- Instrument Calibration
Valoit, Inc.
will provide the client with the documented systems and infrastructure to meet all regulatory requirements for their facilities and processes. Our validation specialists have extensive experience in validating all types of systems and equipment. Our experience has shown that a well planned, logical approach to validation is key for success.Valoit, Inc. can validate new systems, re-validate existing systems and provide ongoing validation training programs. Our validation services are completed in five phases: 1) Design Review/ Project Coordination; 2) Master Plan; 3) Protocol Development; 4) Field Execution; and 5) Reports and Certification. We also offer a variety of validation related services that can be supplied to accommodate existing programs and specific client/product requirements.
During Conception
- Preliminary
Validation Planning
- Regulatory
Consulting Service
- Validation
Training Program Development
During Design
- Validation
Master Planning
- Protocol
Development
- Enhanced
Turnover Package Development
- SOP
Development
- Validation
Training Program Implementation
During Construction
- Enhanced
Turnover Package Development
- Enhanced
Turnover Package Execution
- Protocol
Development
- Initial
Protocol Execution
- SOP
Development
- Ongoing
Validation Training Program
During Start-Up
- Finish
Protocol Development
- Complete
Enhanced Turnover Packages
- Protocol
Execution
- Complete
SOP Development
- Final
Report Writing
- Ongoing Validation Training Program
| Prior to Production Startup | Equipment Validation | Facilities Validation | Computer System Validation |