AI-assisted preparation
Help draft risk assessments and test plans using requirements and practical knowledge, with people reviewing the output and making decisions.
DIGITAL VALIDATION TOOL & PLATFORM
Validation automation.
One connected platform.
ValidCore is a validation automation tool
and Digital Validation Tool (DVT) platform.
Connect requirements, risk assessment, testing,
review and approval in one workflow.
AI helps prepare. People judge and approve.
ValidCorePlatform development vision
CONNECTED VALIDATION
Connect the validation lifecycle
From requirements to results and approval
Requirements and validation scope
Begin with the system’s user requirements and the scope of validation.
A risk-based validation strategy
Connect requirements to risks, validation priorities and the reasoning behind decisions.
A plan for meaningful testing
Prepare tests that link the activity, expected result and evidence needed.
Execution, results and evidence
Design a workflow that keeps test results, evidence and deviations in context.
Review and approve with context
Trace requirements through to results, with people reviewing and approving the work.
AI proposals, human review and approval
Context from requirements to approval
01Validation automation02Lifecycle traceability03Human judgment04An integrated DVT platform
THE CORE OF VALIDATION
Validation work and deliverables.
One connected system.
ValidCore is being built to automate repetitive validation work. It connects document preparation, test planning, execution records and review, so the evidence from one stage can inform the next.
Traceability from requirements
Connect requirements, risks, tests and results. Make it easier to understand what was validated, why it mattered and what evidence supports it.
From execution to deliverables
Design a flow from test execution, evidence and deviations to review records and reports. Reduce the repeated transfer of work into separate documents.
ONE VALIDATION LIFECYCLE
From planning to approval.
Keep the work connected.
Define validation scope around the project’s purpose and risks. Carry the reasoning and records forward at every stage.
- 01
Requirements and scope
Define user requirements and the scope of the validation project.
VP / URS - 02
Risk assessment
Connect requirements, risks and the validation strategy.
RISK ASSESSMENT - 03
Test planning
Prepare tests, expected results, procedures and the evidence needed.
IQ / OQ / PQ - 04
Execution and records
Link results, evidence and deviations to their test items.
EXECUTION / EVIDENCE - 05
Review and approval
Review traceability and results, then move to approval and reporting.
RTM / VSR
Automation with people at the center.
People review and refine AI-generated drafts. We are developing automation that supports validation preparation and execution while preserving the roles of reviewers and approvers.
In developmentThis workflow describes the development vision for the ValidCore DVT platform. Contact us about feature scope and availability.
MEET VALIDCORE IN 75 SECONDS
See validation
come together.
From requirements and risk assessment to test planning, execution and approval. Explore the connected workflow we are building with ValidCore.
This film illustrates the DVT platform vision currently in development. Its integrated workflow is distinct from the features of the local DI CAM app available in stores.
Read the film transcript
ValidCore brings every stage of validation into one connected workflow.
Scattered documents and repeated checks interrupt the flow of work. Our vision connects requirements, risk assessment, test planning, execution, review and approval.
With DICAM, teams photograph equipment in the field and use those images as validation evidence and report attachments.
AI supports risk assessment and test preparation. People make the final decision. We aim to help performers, reviewers and approvers share progress and the context behind each decision.
Connecting the work for clearer validation. ValidCore, by GAMPLAB INC.
DI CAMLOCAL CAMERA APP
DI CAM / LOCAL APP
Explore the local DI CAM app
A work camera for recording capture information with field photos.
Discover the standalone local app that stores photos and capture history on your device, available on Google Play and the App Store.
- Operator, device ID and capture-time watermarks
- Photos and capture history stored on the device
- Capture history and thumbnail review
Store listing: DICAM / Developer: ValidCore
A local camera app for your mobile device. See each store for current features and supported devices.
BUILT BY GAMPLAB
Validation practitioners.
A practical path to automation.
ValidCore is a DVT platform developed by GAMPLAB. We bring experience in computerized system validation and data integrity consulting for pharmaceutical, biotech and other GxP environments into validation automation.
Meet GAMPLABPracticeStart with real validation work
JudgmentRespect reviewers and approvers
ConnectionFrom requirements to results
LET’S CONNECT
Take your validation work
toward automation.
Talk to us about the ValidCore DVT platform, a demonstration, implementation or collaboration.
gxp@validcore.co.krExplore the local DI CAM app