Leading the Way in Life Sciences Compliance
Customer solution Corp technologies has established itself as a frontrunner in providing comprehensive compliance services to the Life Sciences, Pharmaceutical, and Biotech industries. As a full-service provider, we specialize in helping companies navigate the complex landscape of IT-related regulations and guidelines.
Our Approach
At Customer solution Corp technologies, we focus on:
- Enhancing compliance levels
- Reducing compliance-related costs
- Leveraging our deep understanding of current regulatory expectations and international standards
- Combining regulatory knowledge with technological expertise
Industry-Wide Expertise
Our services span across all operational areas within the enterprise, including:
- Research & Development
- Clinical Trials
- Quality Assurance
- Laboratory Operations
- IT/Information Management
- Manufacturing
- Distribution
The Customer solution Corp technologies Advantage
We offer:
- Evaluation and assessment of current business operations
- Solutions to streamline processes and reduce regulatory exposure
- Implementation of standard solutions for increased harmonization
- Management of critical cross-functional business systems
Benefits to Your Organization
- Mitigated risk of non-compliance
- Reduced operational costs
- Increased profitability
- Achievement of Operational Excellence
Our Areas of Expertise
With years of experience in regulated industries, Customer solution Corp technologies offers a unique perspective on FDA and governmental regulatory compliance. Our demonstrated expertise includes:
- Computer Systems Validation (CSV)
- 21 CFR 11 - Electronic Records / Signatures
- Application Validation (requirements, traceability, protocols, scripts, summary reports)
- Localized regulatory compliance assessments and remediation
- Infrastructure qualification
- CSV project management
- Compliance expert coaching for CSV projects
- Training on CSV, Part 11, Auditing, and Testing
- Retrospective evaluation/validation of legacy systems
- System testing
- Supplier audits
- SOP development
- Clinical Adverse Event Systems / Data Management and Safety / CAPA Systems
- Manufacturing Equipment Qualification and Process Systems (C&Q)
Manufacturing Equipment Qualification and Process Systems (C&Q) At Customer solution Corp technologies, we don't just offer compliance services– we partner with you to navigate the complex regulatory landscape, ensuring your business operates at peak efficiency while maintaining the highest standards of compliance.