Computer System Validation Services
FDA 21 CFR Part 11 and EU Annex 11 compliance without complexity.
Guaranteeing Document and System Compliance
We ensure the successful submission of validation/qualification deliverables for 'Software as a Service' systems or Infrastructure. We also ensure your organization is compliant by assessing system releases and performing periodic system reviews.
Why Partner with Us?
Experienced
Team
Our team offers a comprehensive understanding of validation approaches, including computer system assurance and other related techniques.
Comprehensive Approach
Our team specializes in a wide range of applications such as Veeva Suite, Benchling, ZenQMS, and DocuSign Part 11.
Certified
Quality
Our team of experts meticulously executes each step of all projects and operations, ensuring no aspect is overlooked when managing system validation documentation.
How Can We Partner to Optimize Your CSV Processes?
Our team of subject matter experts collaborates with each department to define and optimize processes based on industry best practices while tailoring solutions to your unique needs.
Computer System Validation
Our team creates a CSV/CSA deliverables strategy tailored for validated Cloud/SaaS environments. We leverage vendor documentation and exploratory methods and prioritize testing based on risk, intended use, and data impact.
System Release Management
Our team maintains compliance standards through on-going operations for Cloud/SaaS GxP systems. We review system releases from vendors, perform impact assessments, and apply the CSA approach.
System Periodic Review
Our team ensures traceability, audit readiness, and data integrity throughout the lifecycle for Cloud/SaaS GxP systems to maintain compliance standards. We review quality records, audit trails, user access, trainings, and more.