Scattered information
Documents spread across folders and systems make collaboration between CSV, QA, IT, and business teams harder.
VALIDATION, CONNECTED.
Modernizing
Computer System
Validation.
AI-assisted validation workflows
for regulated life sciences.
ValidationOS is being built to help CSV, QA, and validation teams manage requirements, protocols, execution, evidence, deviations, CAPA, traceability, and reporting through a structured digital workflow.
Early-stage product Building for regulated life sciences
STRUCTURE. EVIDENCE. CONFIDENCE.VOS / 01
A connected validation record
Illustrative workflow01 Planning02 Design03 Execution04 Review
Requirements traceabilityILLUSTRATIVE DATA
| Requirement | Protocol | Execution | Evidence |
|---|---|---|---|
| URS-001 | PQ-001 | Linked | EV-001 |
| URS-002 | PQ-002 | Linked | EV-002 |
| URS-003 | PQ-003 | Linked | EV-003 |
| URS-004 | PQ-004 | Awaiting review | — |
Human review at every critical step
Evidence → Review → Controlled approval
Every requirement has a context.
Every decision has a record.
DESIGNED FOR THE VALIDATION LIFECYCLE
Plan/Execute/Review/Maintain
THE CHALLENGE
Validation workflows are still too fragmented.
When documents, tests, and evidence live in different places, keeping the full validation story connected can take substantial manual effort.
Repetitive manual work
Documentation, test execution, evidence collection, and deviation or CAPA workflows can demand repeated effort.
Gaps in the bigger picture
Difficult traceability and limited project visibility complicate the work of maintaining audit-ready records.
A CONNECTED FOUNDATION
One structured workflow for validation.
ValidationOS aims to bring validation activities into one controlled platform, from the organizational context to the final validation record.
Keep requirements, execution, and evidence connected. Give CSV, QA, IT, and business teams a shared context for the work that needs their attention.
Context carries through.
Each artifact is designed to connect to the system, version, and project it belongs to.
- 01Organization
- 02Client / Site
- 03System
- 04System Version
- 05Validation Project
- 06Plan
- 07Requirements
- 08Protocol
- 09Execution
- 10Evidence
- 11Deviation / CAPA
- 12Validation Report
THE PLATFORM
The detail matters. So does the whole.
Planned capabilities span the validation lifecycle, with connected records and clear responsibilities.
01
Validation Projects
Plan scope, systems, versions, and validation activities in a structured project.
02
Requirements
Organize requirements and connect them to the artifacts that demonstrate coverage.
03
Protocols
Develop controlled protocols and reusable test cases with review in mind.
04
Test Execution
Guide test execution with recorded outcomes and a clear path to review.
05
Evidence
Keep supporting evidence connected to tests, results, and the validation record.
06
Traceability
Follow requirements through protocols, execution, and evidence to identify gaps.
07
Deviations & CAPA
Document deviations and connect corrective and preventive actions to their context.
08
Audit Trails
Maintain a chronological record of changes and workflow activity.
09
Role-Based Access
Define access and review responsibilities around organizational roles.
10
Reporting
Bring validation activities and evidence together in structured reports.
HOW IT IS DESIGNED TO WORK
From scope to a complete record.
- 01
Plan
Define the validation scope, system, requirements, and strategy.
- 02
Design
Create controlled protocols and test cases.
- 03
Execute
Perform testing and capture evidence.
- 04
Review
Review evidence, deviations, and traceability.
- 05
Report
Generate structured validation reporting and maintain the validation record.
ASSISTANCE, WITH ACCOUNTABILITY
AI that assists the validation team.
ValidationOS is designed to use AI where it can reduce repetitive work while keeping validation professionals in control.
Less repetitive work.
More room for professional judgment.
Requirements Analysis
Assist with requirement clarity, consistency, and potential gaps.
Protocol Drafting
Prepare draft validation documents and protocols for expert review.
Test Case Assistance
Suggest test cases using the requirements and validation context.
Traceability Analysis
Help identify missing links and requirements without test coverage.
Evidence Review
Assist reviewers in assessing and summarizing supporting evidence.
Deviation Assistance
Surface relevant context to support deviation analysis.
CAPA Assistance
Support analysis and the drafting of corrective and preventive actions.
Validation Summaries
Summarize artifacts and retrieve knowledge across the validation record.
AI assistance Human review Controlled approval
Potential workflows in development. AI outputs are intended for human review; approval remains with authorized personnel.
CONTROL BY DESIGN
Designed around the realities of regulated validation.
Traceability, accountability, and review are core design considerations—not afterthoughts.
Traceability
Auditability
Controlled workflows
Role-based access
Evidence management
Document control
Review & approval
ValidationOS is being designed to support organizations operating in regulated environments. Specific validation and compliance responsibilities remain with the organization and its qualified personnel.
BUILT WITH YOUR WORK IN MIND
For the teams behind the validation record.
CSV Engineers
Connect requirements to verification.
QA / Quality Teams
Review with context and control.
Validation Teams
Coordinate the validation lifecycle.
IT Quality
Align systems with quality processes.
Life Sciences Organizations
Pharmaceutical, biotechnology, and medical-device organizations.
OUR DIRECTION
Building the operating layer for modern validation.
ValidationOS aims to connect validation planning, execution, evidence, review, traceability, and reporting into a single controlled workflow, with AI assisting teams where appropriate.
An early-stage product. A deliberate approach.
PRODUCT VISION / DEVELOPMENT THEMES
01
Connected foundation
System context, projects, requirements, and controlled documents.
02
Lifecycle continuity
Protocols, execution, evidence, deviations, CAPA, and reporting.
03
Contextual intelligence
AI assistance grounded in validation artifacts and human review.
These themes describe our direction, not a committed release schedule or guarantee of availability.
LET’S START A CONVERSATION
Building the future
of validation.
ValidationOS is an early-stage product being developed for teams working with regulated computerized systems.