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Validated SAS Cloud

GxP-validated SAS cloud access for biostatistics teams with pre-built qualification templates and 21 CFR Part 11 compliance.

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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

  1. Due Diligence
  2. Platform Architecture
  3. Creation
  4. SAS Validation Plan
  5. SAS Installation Qualification
  6. SAS Operational Qualification
  7. Validation Summary and Sign-off
  8. 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.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Computer System Validation (CSV)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotech
Development stage(s)
ClinicalManufacturing
Target user(s)
Bioinformatician / Computational ScientistQA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxP