Validation Services is a vital requirement of regulatory compliance as described in the FDA 21 CFR 11 and EMA Annex 11. The validation process is designed to provide a high degree of assurance that both new and existing computer systems will consistently accomplish their intended purpose by delivering results which meet predetermined specifications and quality attributes.
At Pharmatek, we employ a risk-based approach to the computer system validation (CSV) process ensuring the right amount of testing and documentation is deployed. We have a dedicated team of validation and compliance experts who develop and implement system validation activities based on industry best practices and their significant industry knowledge.
Our Validation services can be adapted and tailored to meet your organizational needs. Our knowledge of life sciences software and systems is extensive and can be leveraged in implementation of your project. Our domain vertical experts have extensive experience in validating COTS (Commercially Off The Shelf) applications and custom developed application/ platforms per GAMP 5, FDA 21 CFR Part 11 and EU Annex 11 regulatory compliance requirements.
Our diverse business allows us to offer vast solutions to people worldwide, which means we serve across widespread geographies with the best technologies. We provide solutions that are cost-effective and exceed expectations every time.
Our CSV processes typically involve:
- GAP Assessment
- System Risk and Regulatory Applicability Assessment
- User requirement specifications
- System Architecture Design
- Validation plan
- Functional requirement specifications
- Network and Infrastructure Qualification
- Installation Qualification (IQ) Scripts and Results
- Operational Qualification (OQ) Scripts and Results
- Performance Qualification (PQ) Scripts and Results
- Traceability Matrix development
- Validation Report
- System Release Documentation
- Hypercare Solutions