Pharmaceutical Validation & Documentation
We Deliver Confidence.
The pharmaceutical industry is an industry of precision. Tight timelines, tight budgets, high expectations, and high pressure. Precision nonetheless. We have lived in this environment since 1995. Our validation and documentation process ensures precision and confidently delivers a product that is consistent, reliable and safe. We help our customers deliver more than pills and solutions.
Our Services
- Automated Process Control System Documentation
- Equipment Validation Documentation
- Information System Compliance
- Project Management and Consulting Services
- HVAC & Utility Validation
- Lab Equipment Validation
Additional Services
- Engineering Turnover Packages (ETOP)
- Commissioning
- Factory Acceptance Test (FAT)
- Site Acceptance Test (SAT)
- Validation Plans
- Gap Analysis for Legacy Systems
- Risk Assessments
- Failure Modes Effects Analysis (FMEA)
- Installation Qualifications (IQ)
- Operational Qualifications (OQ)
- Performance Qualifications (PQ)
- User Requirements Specifications
- Detailed Design Specifications
- Trace Matrices
- Summary Reports
- Standard Operating Procedures