Celestix AI
Celestix AI
Products/ValDoc

ValDoc

Veeva Vault Validation Documents

Automated validation document generation platform for Veeva Vault. ValDoc accelerates your validation lifecycle while ensuring regulatory compliance and audit readiness with comprehensive, standardized documentation.

21 CFR Part 11
GAMP 5 Aligned
EU Annex 11
Validation Package
In Progress
Documents Generated8 / 12
Completed
VP, URS, FRS
In Review
IQ, OQ
Compliance Score
98%
Platform Features

Intelligent Validation Automation

ValDoc combines pre-approved templates with intelligent automation to generate comprehensive, compliant validation documentation in a fraction of the time.

Template-Based Generation

Pre-built, industry-standard templates for IQ, OQ, PQ, and other validation protocols aligned with GAMP 5 guidelines.

Veeva Vault Integration

Seamless integration with Veeva Vault QMS, QualityDocs, and other Vault applications for unified document management.

21 CFR Part 11 Compliance

Built-in controls for electronic signatures, audit trails, and access controls meeting FDA 21 CFR Part 11 requirements.

Automated Updates

Keep validation documents current with automated versioning and change tracking as your Vault configuration evolves.

Traceability Matrix

Automatic generation of requirements traceability matrices linking user requirements to test scripts and results.

Gap Analysis

Identify missing documentation and compliance gaps with intelligent analysis of your validation package.

Document Types

Complete Validation Package

ValDoc generates all the documentation you need for a complete, audit-ready validation package. From planning through execution to summary reports.

See Document Samples
Validation Plan (VP)
User Requirements Specification (URS)
Functional Requirements Specification (FRS)
Configuration Specification (CS)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Traceability Matrix (TM)
Validation Summary Report (VSR)
Risk Assessment Documents
Change Control Documentation
Periodic Review Reports
How It Works

Streamlined Validation Workflow

01

Configure

Define your Vault configuration, user requirements, and validation scope.

02

Generate

Automatically create validation documents from pre-approved templates.

03

Review

Collaborative review and approval workflows with electronic signatures.

04

Execute

Execute test scripts and capture results with full traceability.

Measurable Results

Proven Impact

70%
Faster Validation
Reduce validation cycle time
100%
Compliance
21 CFR Part 11 adherence
50%
Cost Reduction
Lower documentation costs
0
Findings
Audit-ready documentation
Who It's For

Built for Life Sciences

Pharmaceutical Companies

Streamline validation for clinical, quality, and regulatory Vault applications.

Biotechnology Firms

Accelerate GxP system qualification with standardized documentation.

CROs & CDMOs

Maintain consistent validation standards across multiple client projects.

Veeva Partners

Deliver comprehensive validation packages for client implementations.

Ready to Accelerate Your Validation?

Join leading life sciences companies using ValDoc to streamline Veeva Vault validation and ensure regulatory compliance.