Our industry-leading compliance experts apply their knowledge and technical expertise through all phases of the validation life cycle. We support all related validation requirements to ensure the consistency and quality of the manufacturing product, including equipment, utilities, processes, systems, and procedures.

For CSV and data integrity, we empower our clients to face their compliance concerns and challenges by leveraging our Knowledge, Skill & Passion. Our approach to CSV is based upon the fundamental understanding that in order to deliver cost-effective, computerized systems compliance one must implement a series of controls and assess risk across all stages of the system life cycle. We are experts at 21 CFR Part 11 compliance, ALCOA+CCEA principles, data integrity methodology, and COTS & customized systems. Our CSV and data integrity services include:

• CFR Part 11 and EU Annex 11 compliance assessments and program development
• Mock data integrity audits and compliance gap assessments
• Risk-based framework (GAMP5) 
• Compliant cloud computing environments: SaaS, Paas, and IaaS
• Medical Device 21 CFR Part 820 consulting
• SDLC, VLC testing
• Data migration
• Disaster recovery