PHARMACEUTICAL VALIDATION
We provide start-to-end Validation services to our clients which include:
- Equipment & Instrument Qualification
- Cleaning Validation
- Facilities & Utilities Validation
- Process Validation
- Computer Systems Validation
- Regulatory Affair
- Quality Engineer
- Quality Assurance
- Document Control
Validation Deliverables
Arrowtek Technologies's validation and Qualification services are supported by a well-trained team of validation consultants to support clients to author the validation life cycle deliverables. We use a GMAP 5 - risk-based approach to focus on validation activities. Our Team of Validation Engineers are experts in developing below validation documentation:
- Validation Plan
- System Impact Assessment
- GxP Applicability and Criticality Assessment
- 21 CFR Part 11 Assessment
- Risk Assessment
- User Requirement Specification
- Functional Specification
- Configuration /Design Qualification
- Factory Acceptance / Site Acceptance / Commissioning Test
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Requirement Traceability Matrix
- Validation Summary Report
- Change Control
- CAPA and Deviation records
- Periodic Review of all GMP Systems
- Data Integrity Assessment
- Gap Analysis
- Remediation Plan
Other services
- IT Consulting
- Business Analyst
- Project Management
- Application Devenoplment
- Clinical Services - Pharmacovigilance