Pharmaceutical Validation
 Our Pharmaceutical Engineering and Validations
Practice focuses on providing total integrated engineering and
cGMP (current
Good Manufacturing Practices) compliant services to the pharmaceutical
industry. We specialize in providing consultation, engineering
design,
procurement, and validations of facilities, utilities, equipment,
and computer systems and processes, including:
- Compliance with
Federal Regulations, such as 21 CFR Part 11 Amendments
- Validation Master Plan Development
- Protocol Development and Execution
- Installation Qualifications
- Operation Qualifications
- Performance Qualifications
- Change Control Verification
- Data Interpretation, Comparison, and Report Generation
- Drawing Comparison/Revisions
- Drawing Development
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