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AI Digital Workforce™

The Future of AI-Powered Digital Validation™

Human-Guided. AI-Assisted. Validation Professional-Approved.

Accelerate validation through intelligent AI assistants designed specifically for regulated industries while maintaining complete human oversight and regulatory compliance.

Be among the first organizations to experience the next generation of digital validation. TestMaster AI™ is currently under development and is expected to enter Early Access soon.

Join the Early Access ProgramExplore TestMaster AI™

Coming Soon · Early Access Available

Isometric illustration of the AI Digital Workforce Assistants™ connected around a central orchestration hub, ending at a final approval step

Business outcomes

The AI-Powered Intelligence Engine of ValidationMaster®

TestMaster AI™ is the AI-powered intelligence engine of the ValidationMaster® Enterprise Digital Validation Platform™ and the industry's first AI-powered Digital Validation platform for regulated industries. It is designed to help your organization reduce validation effort, move through each release faster, and stay inspection-ready, while qualified validation professionals approve every regulated deliverable.

Reduce Manual Validation Effort

AI assistants support requirements analysis, test generation, and traceability, so your experts can focus on review and approval.

Meet the AI Assistants

Accelerate Validation Cycles

Coordinated assistants support every phase of the lifecycle, helping your teams keep pace with enterprise and cloud release schedules.

See the AI Lifecycle

Strengthen Inspection Readiness

Evidence, traceability, and audit trails stay within one governed validation record, supporting complete auditability.

Explore Validation Intelligence™

Advance Computer Software Assurance

Risk-based, AI-assisted workflows help you focus validation effort where risk to patient safety and product quality is highest.

Explore AI Governance

AI Digital Workforce™

Meet Your AI Digital Workforce Assistants™

TestMaster AI™ includes a coordinated team of intelligent AI assistants designed to automate and accelerate every phase of the validation lifecycle. Each assistant performs specialized validation activities while collaborating through our AI Orchestration Layer™ under human oversight.

Initial assistants include:

Requirements Analyst™

Analyzes system requirements for clarity, completeness, and testability, and flags validation considerations for your team.

Document Intelligence™

Reviews validation and source documentation and extracts the information your team needs, accelerating document review.

Validation Planner™

Helps your team structure validation strategy, scope, and activities based on requirements and risk.

Test Author™

Generates AI-assisted test content from requirements, risk, and validation objectives.

Test Reviewer™

Reviews AI-generated test content for gaps and inconsistencies, and highlights the items that need a validation professional's attention.

Traceability Manager™

Establishes and maintains the links between requirements, risks, tests, and validation evidence.

Validation Evidence Manager™

Organizes and manages objective evidence throughout testing and validation.

Validation Dossier Manager™

Assembles validation documentation and final deliverables for review and electronic signature.

Validation Intelligence™

Turns validation data into actionable insight through analytics, dashboards, predictive reporting, and executive metrics.

Schedule a Personalized AI Demonstration

Coordinated intelligence

Powered by the AI Orchestration Layer™

At the core of TestMaster AI™ is an intelligent orchestration layer that coordinates multiple large language models, enterprise knowledge bases, AI assistants, validation workflows, governance services, and security controls to deliver accurate, explainable, and compliant validation outcomes. The AI Orchestration Layer™ connects specialized assistants and validation activities into one coordinated workflow while maintaining human oversight and enterprise governance.

AI Orchestration Layer™ architecture: an application connects to the orchestration layer, which routes work to large language models, AI agents, a vector database and enterprise knowledge base, under governance, audit logging and security services, and delivers results into ValidationMaster® validation workflows.
LLM Routing Directs each task to the large language model best suited to it.
AI Agents The specialized AI Digital Workforce Assistants™ that perform each validation activity.
Prompt Management Maintains governed prompts so AI behavior stays consistent and reviewable.
Vector Database Indexes validation knowledge so assistants retrieve the right context.
Enterprise Knowledge Base Grounds AI output in approved validation knowledge and regulatory content.
Governance Engine Applies guardrails and policy controls to every AI-assisted activity.
Audit Logging Records AI-assisted activity for review, audit, and inspection.
Security Services Protects data and access across the orchestration layer.
Validation Workflows Routes AI output into ValidationMaster® review and approval workflows.

  1. LLM Routing

    Directs each task to the large language model best suited to it.

  2. AI Agents

    The specialized AI Digital Workforce Assistants™ that perform each validation activity.

  3. Prompt Management

    Maintains governed prompts so AI behavior stays consistent and reviewable.

  4. Vector Database

    Indexes validation knowledge so assistants retrieve the right context.

  5. Enterprise Knowledge Base

    Grounds AI output in approved validation knowledge and regulatory content.

  6. Governance Engine

    Applies guardrails and policy controls to every AI-assisted activity.

  7. Audit Logging

    Records AI-assisted activity for review, audit, and inspection.

  8. Security Services

    Protects data and access across the orchestration layer.

  9. Validation Workflows

    Routes AI output into ValidationMaster® review and approval workflows.

Explore the AI Architecture

Governance and compliance

AI Governance Built for Regulated Industries

TestMaster AI™ was designed specifically for regulated industries where validation, traceability, data integrity, and human oversight are mandatory. Every AI-assisted activity operates within a governed framework that supports FDA CSA principles, GAMP® 5 Second Edition guidance, electronic records and signatures, and complete auditability.

Isometric governance illustration: three layered shields protecting the ValidationMaster® platform core, with a checkmark on the front shield.

Human Oversight

Qualified validation professionals review and approve every AI-assisted activity and output.

AI Audit Trail

Governed audit trails give you visibility into AI-assisted activities and validation decisions.

FDA CSA Support

Supports risk-based Computer Software Assurance through AI-assisted validation workflows and testing.

GAMP® 5 Second Edition Alignment

Designed to support validation practices aligned with GAMP® 5 Second Edition guidance.

21 CFR Part 11 Compliance

Supports your electronic records, electronic signature, and audit trail requirements under 21 CFR Part 11.

ALCOA+ Data Integrity Principles

Applies ALCOA+ data integrity principles across AI-assisted activities and validation records.

Explore AI Governance

Across the lifecycle

AI-Powered Validation Lifecycle™

TestMaster AI™ intelligently supports every phase of the validation lifecycle, from requirements analysis and risk assessment through test planning, automated test generation, execution, evidence collection, traceability, and final validation reporting. Every activity is coordinated through the AI Orchestration Layer™ while remaining under human oversight.

  1. 01

    Analyze requirements for clarity, completeness, and testability.

    The Requirements Analyst™ and Document Intelligence™ assistants review source documents and requirements, flag ambiguity and gaps, and propose refinements for your team to approve.

  2. 02

    Focus effort where risk is highest.

    TestMaster AI™ suggests risk classifications that support FDA Computer Software Assurance principles, and your validation professionals confirm every risk decision.

  3. 03

    Build a risk-based validation strategy.

    The Validation Planner™ drafts the validation approach, scope, and deliverables from your requirements and risk profile, ready for human review and approval.

  4. 04

    Create test content from requirements and risk.

    The Test Author™ generates test content from approved requirements, and the Test Reviewer™ checks it for gaps and inconsistencies before your team approves it.

  5. 05

    Run tests with AI-assisted support.

    TestMaster AI™ supports automated and assisted test execution and records results as the work happens.

  6. 06

    Capture objective evidence as tests run.

    The Validation Evidence Manager™ organizes execution results and supporting records into governed evidence linked to each test.

  7. 07

    Keep every requirement connected to its evidence.

    The Traceability Manager™ maintains the links between requirements, risks, tests, and evidence, so coverage gaps stay visible throughout the lifecycle.

  8. 08

    Assemble reports and the final validation dossier.

    The Validation Dossier Manager™ compiles summary reports and deliverables for qualified reviewers to approve with electronic signatures.

Experience the Complete Validation Lifecycle

Executive insight

Validation Intelligence™

Validation Intelligence™ transforms validation data into meaningful business insights by combining AI-generated analytics, real-time dashboards, predictive reporting, and executive performance metrics. Gain complete visibility into validation readiness, project health, regulatory risk, and organizational performance from a single enterprise dashboard.

Isometric illustration of AI analyzing connected validation data points under a magnifying lens

Executive Dashboards

A portfolio-level view of validation status for leadership.

Requirements Coverage

See which requirements are tested, traced, and approved.

Validation Readiness

Track how close each system is to release or go-live.

Test Progress Analytics

Monitor test execution progress, results, and open issues.

Risk Heat Maps

Visualize where quality and regulatory risk is concentrated.

AI Recommendations

Review AI-suggested next actions, with your team making the decisions.

Traceability Status

Identify gaps between requirements, risks, tests, and evidence.

Regulatory Compliance Metrics

Monitor compliance indicators across your validation portfolio.

See Validation Intelligence™ in Action

Human oversight

Human-Guided AI™

Artificial Intelligence should accelerate validation, not replace qualified validation professionals. Every AI-generated requirement, test script, traceability relationship, validation recommendation, and deliverable remains under human review, approval, and electronic signature before becoming part of the validated record.

Human-Guided. AI-Assisted. Validation Professional-Approved.

Learn How Human-Guided AI™ Works
Isometric workflow: AI-generated content moves through review, electronic signature and approval checkpoints into a secured, audit-trailed validation record

Human Review

Qualified professionals review every AI-generated output before it enters the validated record.

Electronic Signatures

Validation professionals retain approval authority through governed electronic signatures.

Audit Trail

Every AI-assisted activity remains traceable within the validation record.

Regulatory Compliance

AI workflows operate within a framework designed for regulated environments.

Complete Traceability

Requirements, risks, tests, evidence, and deliverables stay connected across the lifecycle.

Platform integration

Powered by the ValidationMaster® Platform

TestMaster AI™ operates inside the ValidationMaster® Enterprise Digital Validation Platform™, not alongside it. AI-assisted work flows directly into the same governed environment your teams use for validation execution, mobile field work, reporting, and enterprise integration. Your AI-assisted activities, evidence, and approvals stay within one governed validation record.

ValidationMaster Studio™

The ValidationMaster® application where teams plan, execute, track, report and approve validation work.

Isometric platform hub: TestMaster AI™ at the top, connected to six ValidationMaster® platform components below

Side-by-side comparison

Why TestMaster AI™ Is Different

Unlike general-purpose AI testing tools, TestMaster AI™ was purpose-built specifically for regulated industries. It combines Human-Guided AI™, an AI Digital Workforce™, enterprise governance, validation intelligence, complete traceability, and regulatory compliance into a single integrated platform designed to support the complete validation lifecycle.

TestMaster AI™ includes Generic AI Tools: not built in

  • Human-Guided AI™

    AI accelerates the work, and qualified professionals keep review and approval authority.

  • AI Digital Workforce™

    Specialized assistants collaborate across validation activities and workflows.

  • Validation Intelligence™

    Validation data becomes enterprise insight and performance metrics.

  • Enterprise Governance

    AI activity runs inside governed workflows, security controls, and guardrails.

  • Complete Validation Lifecycle

    Support from requirements through final validation reporting.

  • Traceability

    Requirements, risks, tests, evidence, and deliverables stay connected.

  • FDA CSA Support

    Risk-based approaches that support Computer Software Assurance.

  • GAMP® 5 Second Edition Alignment

    Supports validation practices aligned with GAMP® 5 Second Edition guidance.

  • Part 11 Compliance

    Supports electronic records, electronic signatures, and auditability.

Discover the TestMaster AI™ Difference

Trust and accountability

Built for Trusted AI in Regulated Industries

In regulated environments, AI is valuable only when you can trust, explain, and defend its output. TestMaster AI™ pairs Human-Guided AI™ with enterprise governance, complete auditability, and Validation Intelligence™, so every AI-assisted activity is reviewed, traceable, and ready for inspection. You get faster validation without giving up the control your quality organization and regulators expect.

Isometric illustration of a secure vault, door half open, protecting the ValidationMaster® platform core.

TestMaster AI™ is designed for organizations that are:

  • Implementing FDA Computer Software Assurance (CSA)

  • Aligning Validation Practices with GAMP® 5 Second Edition

  • Validating Cloud and SaaS Applications

  • Validating ERP Implementations and Upgrades

  • Establishing Governance for AI in Regulated Environments

  • Moving to Continuous Validation

Coming Soon · Early Access Available

Early Access Program

Why Join the Early Access Program?

Organizations selected for the Early Access Program will receive exclusive access to TestMaster AI™ prior to general availability and will have the opportunity to collaborate directly with OnShore's product management and engineering teams. Early Access participants will help validate new AI capabilities, provide product feedback, influence future enhancements, and evaluate how AI can accelerate Computer Software Assurance (CSA) initiatives within regulated environments.

Exclusive Early Access

Evaluate TestMaster AI™ before public release.

Product Roadmap Influence

Provide direct feedback to our Product Management team.

Executive Strategy Sessions

Participate in exclusive product briefings and roadmap reviews.

Dedicated Technical Support

Work directly with our AI engineering and validation specialists.

Preferred Commercial Terms

Receive preferred pricing and licensing incentives available only to Early Access participants.

Recognition

Become one of the first organizations helping define the future of AI-powered Digital Validation.

Who should apply

Ideal Early Access Organizations

Suitable Organizations

  • Pharmaceutical Manufacturers
  • Biotechnology Companies
  • Medical Device Manufacturers
  • Cell & Gene Therapy Organizations
  • Compound Pharmacies
  • Vaccine Manufacturers
  • Nutraceuticals
  • CDMOs
  • CROs
  • All other life sciences market sectors
  • Life Sciences Software Vendors
  • FDA-Regulated Manufacturers
  • Organizations implementing FDA Computer Software Assurance (CSA)
  • Organizations seeking to modernize validation through AI

What to expect

Program Expectations

What Participants Can Expect

  • Access to selected pre-release functionality
  • Product capabilities that continue to evolve throughout the program
  • Regular software updates
  • Opportunities to participate in product feedback sessions
  • Direct communication with the OnShore Product Management team
  • Participation in periodic Early Access webinars

Important Note: TestMaster AI™ is currently under active development. See the Early Access Disclaimer in the sign-up form below.

Early Access sign-up

Join the TestMaster AI™ Early Access Program

Please complete the form below.

Early Access Disclaimer: TestMaster AI™ is currently under active development. Capabilities demonstrated during the Early Access Program may change prior to general commercial availability. Participation in the Early Access Program provides organizations with an opportunity to influence future product direction while evaluating emerging capabilities.

Contact Information

Organization Information

Current Validation Platform
Areas of Interest

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Coming Soon

Now Accepting Early Access Organizations

Be among the first organizations to experience AI-assisted validation built specifically for regulated industries.

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