Services
Qualification & Validation Services
- Site Master Planning
- Validation Planning
- Preparation of User Requirement Specifications (URS)
- Impact Assessments
- Risk Assessments
- Design Review and Qualification
- Factory & Site Acceptance Testing
- Commissioning
- Temperature Mapping
- Equipment Qualification (IQ / OQ / PQ)
- Medical Device Qualification (ISO 13485)
- Computer System Validation
- Cleaning Validation
- Process Validation
- Summary Reporting
- Revalidations and Periodic Reviews
- Decommissioning
BSL has experience supplying to large EPCM (V) project delivery specialist companies as well as small niche professional services companies.
Support Services
- Project Management
- SOP Development
- Personnel Training
- Specific Validation Training
- Data Integrity Assessments
- Compliance Gap Analysis
- FDA / MHRA inspection readiness and audit support
- FDA / MHRA remediation
