
Validated SAS Cloud
GxP-validated SAS cloud access for biostatistics teams with pre-built qualification templates and 21 CFR Part 11 compliance.
Overview
Validated SAS Cloud by Circulant Solutions Inc. is a purpose-built, GxP-compliant cloud solution designed to give Biostatistics teams at emerging pharma companies fast, reliable access to SAS datasets. Circulants, headquartered in Pleasanton, California, focuses exclusively on helping Bio-Pharma organizations accelerate time to market by combining deep cloud expertise with pre-built validation frameworks that reduce the time and effort typically required for compliance-driven deployments.
The solution leverages leading cloud platforms including Microsoft Azure and Amazon Web Services (AWS), and supports the full cloud lifecycle — from infrastructure consolidation and standardization to virtualization, application re-engineering and re-architecture, and ongoing administration and monitoring. Circulants also assists clients in defining appropriate cloud computing deployment models suited to their specific regulatory and operational needs.
GxP Offerings
- Cloud Qualification
- Infrastructure Qualification
- GxP Risk and Compliance Assessment
- Paperless Validation
- Computer System Validation (CSV) services
- 21 CFR Part 11 Analysis
Key Features
- Pharma Focus: A technology company with dedicated expertise in the pharmaceutical industry
- Cloud Infrastructure: End-to-end cloud infrastructure design, implementation, and support
- GxP Compliance: Pre-built qualification and validation packages to accelerate regulatory compliance
- BI and SAS: Kick-start capabilities with pre-built SAS test cases for Installation Qualification (IQ) and Operational Qualification (OQ) implementation
- Data Engineering: A strong data engineering and analytics team to support clinical and commercial data needs
Solution Approach
- Due Diligence
- Platform Architecture
- Creation
- SAS Validation Plan
- SAS Installation Qualification
- SAS Operational Qualification
- Validation Summary and Sign-off
- Deployment and Hand-off
Validated SAS Cloud is delivered with full lifecycle support, making it well suited for emerging pharma companies that need a scalable, compliant SAS environment without the overhead of building validation documentation from scratch. The solution's pre-built templates and structured approach help organizations meet GxP and 21 CFR Part 11 requirements efficiently while maintaining flexibility as their infrastructure needs evolve.
