GxP Compliant Documentation
HelixOps
Validation Documentation
Complete GxP validation documentation suite for the HelixOps Enterprise SaaS Platform. Built following GAMP 5 guidelines with full requirements traceability.
V-Model Validation Lifecycle
Traces to
Validates
160+
Requirements
123
Specifications
31
Test Cases
60+
Tables
Validation Documents
Complete documentation chain from product requirements through design specifications to qualification protocols.
PRD
Product Requirements Document
High-level product vision, stakeholder needs, and success criteria
BRD
Business Requirements Document
Detailed business requirements with traceability to PRD
FS
Functional Specification
System behaviors, workflows, and functional requirements
DS
Design Specification
Technical architecture, data models, and implementation details
OQ
Operational Qualification
Installation and configuration verification tests
PQ
Performance Qualification
End-to-end functional and performance validation tests
Regulatory Compliance
HelixOps validation documentation meets requirements for major regulatory frameworks.
21 CFR Part 11
EU Annex 11
GAMP 5
GDPR
SOC 2
ISO 27001