ValSuite — Audit-Ready Validation

Controlled Software Validation
From Requirement to Package

A structured validation lifecycle platform for pharmaceutical, biotech, medical device, and regulated IT teams. Replace scattered documents, email approvals, and manual traceability with one controlled workspace.

GxP 21 CFR Part 11 IQ / OQ / PQ AI-Assisted Audit-Ready Electronic Signatures
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Validation Lifecycle
Client→ Project→ Version→ Module→ Requirement→ Design→ IQ/OQ/PQ→ Execution→ Evidence→ Final Package
The Problem We Solve
Validation Shouldn't Be a Document Scramble

Software validation teams in regulated environments spend enormous effort rebuilding packages, chasing reviewers, reconciling traceability, and proving completeness — often under audit pressure with inconsistent documentation and disconnected tools.

The Status Quo Is Expensive

Most validation teams manage their work across Word documents, Excel traceability matrices, shared folders, email approval chains, and manually assembled evidence packages. The result: unclear approval history, incomplete traceability, expensive rework late in the project, and significant risk at audit time. Every new project starts with copying old documents and hoping nothing was missed.

One Controlled Workspace

Requirements, design specs, IQ/OQ/PQ steps, approvals, evidence, deviations, and export packages all live in one connected system. Nothing scattered.

End-to-End Traceability

Every requirement links through design specifications to qualification steps, execution evidence, and final output. Traceability gaps surface before they become audit findings.

Controlled Approval Workflows

Review, approve, sign, and track all records through formal workflows with electronic signatures, role-based access, and full audit history.

Faster Package Preparation

Structured reuse, version inheritance, CSV import, and AI-assisted drafting accelerate repeat validation work. Teams focus on decisions, not document assembly.

Inspection-Ready Output

Export authoring documents, traceability matrices, IQ/OQ/PQ scripts, execution summaries, and finalized validation packages — formatted and complete.

Risk-Based Validation Support

Risk classification, coverage review, readiness checks, and traceability gap detection give QA teams early visibility into what's missing and what's at risk.

Platform Capabilities
Everything the Validation Lifecycle Requires

ValSuite manages the complete set of records, workflows, and controls needed for structured software validation in regulated environments.

Authoring & Structure
Structured requirements with module organisation
Design specifications linked to requirements
IQ, OQ, and PQ qualification step authoring
Risk-based classification per requirement
Version control and project inheritance
CSV import and content reuse patterns
Workflow & Approvals
Review and approval workflows for all record types
Electronic signatures with re-authentication
QA approver role and separate QA approval step
Pending work queues for every role
Revision control with superseded history
Draft revision workflows for approved records
Execution & Evidence
Execution run management with pre-approval
Step-by-step execution with pass/fail results
Evidence attachment per execution step
Deviation creation, investigation, and closeout
Correction and re-execution workflows
Post-execution review and approval
Traceability & Readiness
End-to-end traceability matrix
Coverage review across all lifecycle stages
Traceability gap detection and reporting
Validation readiness checks before export
Export of complete validation packages
Authoring docs, scripts, summaries, and matrices
Security & Governance
Role-based access control per client and project
Local, Microsoft 365, and Active Directory auth
Full audit trail — who, what, when, why
Feature-based licensing and administration
Read-only safeguards for controlled deployments
Multi-client and multi-project isolation
AI-Assisted Validation
AI Built for GxP. Not Generic.

ValSuite's AI understands the distinction between a requirement, a design specification, and a qualification step — because that distinction matters in a regulated environment.

Validation-Aware AI Assistance

ValSuite's AI layer respects your validation scope: non-validated requirements are never flagged as gaps, and only enabled qualification types generate test case suggestions. AI is a drafting and review aid only — it never bypasses human review, approval workflows, or explicit user save actions.

AI generates draft content only. Human users remain accountable for all review, approval, and saved records.

Requirement AI Assist

Improves wording and testability. Enforces shall language and WHAT/HOW discipline — never suggests implementation detail in a requirement.

Design Spec AI Assist

Suggests clearer technical design language, assesses coverage against the parent requirement, identifies gaps, scope warnings, and candidate test cases.

Test Case AI Assist

Enhances conditions and expected results, recommends design spec links, identifies coverage gaps across all design specs, and suggests missing steps by type.

Bulk Draft Generation

Generates a complete first draft of requirements, designs, and test cases from a system overview. Full human review before any records are created.

ValSuite AI Assistant

A floating project-aware assistant answering GxP validation questions using live project context — readiness, traceability gaps, pending approvals, and record details.

AI Governance & Control

Usage logging, monthly token limits, per-client enablement, admin dashboard, full audit trail for every AI generation and applied suggestion.

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Secure Key Storage

API keys stored in Windows Credential Manager. Never in source code or config files.

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Full Audit Trail

Every AI generation and applied suggestion recorded with user, timestamp, and context.

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Human Accountability

AI-generated content flagged until human-edited. Disclaimer acknowledged before first use.

Licensing & Pricing
Simple, Transparent Pricing

Licensed as an annual subscription by user tier. No per-seat counting within a tier. All tiers include the full platform and 12 months of support and updates.

Tier 1
Starter
$4,800/year
Up to 3 users · ~$400/mo
Full ValSuite platform
All validation lifecycle features
Electronic signatures & audit trail
Export & package generation
12 months support & updates
Tier 2
Professional
$9,600/year
Up to 10 users · ~$800/mo
Full ValSuite platform
All validation lifecycle features
Electronic signatures & audit trail
Export & package generation
Multi-client & multi-project support
12 months support & updates
Tier 3
Enterprise
$18,000/year
Unlimited users
Full ValSuite platform
All validation lifecycle features
Electronic signatures & audit trail
Export & package generation
Multi-client & multi-project support
Custom onboarding & training included
Optional Add-On

AI Assistance Module

Adds AI Assist for requirements, design specs, and test cases; bulk draft generation; the floating ValSuite AI Assistant; admin usage dashboard; and all AI governance and audit trail features. Available on any tier. Billed monthly.

$150
per month · any tier

Prefer a One-Time Purchase?

Perpetual licenses include 3 years of support and updates. After 3 years, continue using ValSuite at no cost or renew at the annual rate.

Starter (1–3 users) $14,400
Professional (1–10 users) $28,800
Enterprise (unlimited) $54,000
All prices in USD. Annual subscriptions invoiced upfront. First-customer reference pricing available — contact us to discuss. AI add-on requires a valid OpenAI API connection managed through ValSuite admin settings. Perpetual license includes 3 years of support and updates; annual renewal available thereafter.
Ideal Customers
Built for Regulated Teams

ValSuite is built for organizations that validate software in regulated or quality-critical operations — especially teams managing validation programs repeatedly across multiple projects.

Pharmaceutical & Biotech

GxP software validation for LIMS, ERP, MES, and quality systems. CSV and CSA programs requiring formal IQ/OQ/PQ, traceability, and Part 11-aligned approval controls.

Medical Device

Software validation supporting design controls and quality management systems. Structured evidence, controlled approvals, and inspection-ready documentation.

Validation Service Providers

CROs and validation consultancies managing multiple client projects. Multi-client isolation, structured reuse, and consistent deliverable quality across engagements.

Regulated IT & Laboratory

IT teams and laboratory operations validating infrastructure, software, and instrumentation systems requiring formal qualification evidence.

Business Outcomes
01
Faster validation package creation through structured reuse, import, inheritance, and AI-assisted drafting
02
Better audit readiness through connected records, signatures, audit trail, evidence, and traceability
03
Fewer late-stage gaps by surfacing missing design, test, approval, and execution coverage early
04
More consistent validation deliverables across projects, versions, clients, and teams
05
Reduced dependency on manually maintained spreadsheets and recycled documents
06
Stronger governance through revision control, role-based access, and electronic approval controls

Compliance Positioning

ValSuite is designed to support GxP validation programs and Part 11-aligned operating models when deployed with appropriate customer SOPs, infrastructure controls, access governance, backup and retention practices, and system validation. Key technical capabilities include unique users, access control, audit trail, electronic approval support, controlled revisions, execution evidence, deviation handling, AI-use traceability, and validation package export.

Ready to See
ValSuite?

Request a live demo and see your validation lifecycle managed in one controlled workspace. We'll walk you through the platform using a real GxP validation scenario relevant to your team.

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Phone
579-679-8783
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Brochure
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