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Sierra GxP Cloud Validation

Automate creation, inspection, and continuous validation of cloud infrastructure policies for GxP compliance.

Solution by Sierra Labs
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Overview

Sierra GxP Cloud Validation is a cloud compliance and validation tool from Sierra Labs designed for life science organizations operating in regulated GxP environments. It automates the creation, inspection, configuration, publishing, and validation of cloud infrastructure policies, supporting continuous compliance with regulatory requirements.

The tool is part of the broader Sierra Cloud suite, which also includes Sierra Policies & Procedures, Sierra Document Automation, and Sierra Quality Management.

Cloud Configuration Inspection and Generation

  • Connects securely to an existing AWS environment to auto-inspect the current configuration.
  • Automatically generates cloud configuration documentation based on the live environment.
  • Checks the AWS environment against defined cloud infrastructure policies to confirm alignment.

Document Publishing and Review

  • Automates the generation of documentation for cloud configurations.
  • Supports review and approval workflows to meet company quality requirements.
  • Produces documentation suitable for auditing purposes in regulated settings.

Continuous Cloud Validation

  • Allows users to create test plans for ongoing automated testing of cloud configurations.
  • Executes tests continuously and generates real-time reports on current cloud configuration status.
  • Supports ongoing compliance monitoring rather than point-in-time assessments.

Sierra GxP Cloud Validation is targeted at life science companies with regulated cloud infrastructure needs, particularly those using AWS. It is available as part of the Sierra Cloud platform, and demos are available on request.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Computer System Validation (CSV)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechMedical Devices
Development stage(s)
ClinicalManufacturingPreclinical / Pre-Market
Target user(s)
QA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GDPRGxPHIPAAISO 13485SOC 2