Maintain a centralized library of approved protocols, then deploy them to any CDMO organization in minutes — with full access control, data integrity, and regulatory compliance built in.
Five steps from library to execution. Valkit.ai's organizational cloning architecture moves validated protocols from sponsor to CDMO with structure, content, and configuration intact.
Sponsor maintains a master library with approved protocols, requirements, risk assessments, and test cases.
Global Clone deploys packages to CDMO organizations in minutes. Tags enable site-specific customization.
CDMOs see only their own organization. The Sponsor sees all. No cross-CDMO visibility.
CDMO personnel execute test steps, record results, and capture evidence. No authoring or approving.
Sponsor stakeholders review and approve remotely with PIN-authenticated e-signatures.
Build and maintain a master library of approved validation packages that serve as the single source of truth for every tech transfer engagement. IQ/OQ/PQ protocol suites, equipment commissioning, cleaning and process validation packages; pre-authored sections with AI-generated requirements, risk assessments, and test protocols; reusable tag libraries; full customization of cloned packages in less than 5 minutes.
What the Library Contains
Package Types
Clone entire validation packages — documents, structure, content, formatting, and configuration — from the sponsor's master library to any CDMO organization. Content, formatting, and package settings carried over; tag libraries enable rapid site-specific customization after clone; sponsor maintains admin visibility of all cloned organizations.
| What Gets Cloned | Detail |
|---|---|
| All Documents & Structure | Cloned intact |
| Content & Formatting | Carried over |
| Package Settings & Config | Included |
| Data Capture Tables | Optional |
| Test Execution Results | Per clone |
| Evidence & Approvals | Per execution |
Each CDMO organization is fully isolated. The Sponsor, as Admin/Owner across all organizations, maintains complete oversight while CDMOs operate independently. Sponsor views all CDMO organizations and their packages; each CDMO sees only their own organization with no cross-CDMO visibility; CDMO access can be limited to Execution role only.
Sponsor Organization
Admin/Owner — sees all organizations, monitors progress, reviews & approves remotely
CLONES PROTOCOLS TO
CDMO A — Dublin
Sees self only
CDMO B — Singapore
Sees self only
CDMO C — Indiana
Sees self only
Sponsor, CDMO & vendor roles. Configure granular permissions per document within each validation package. Roles with Execute permission cannot hold Approve rights on the same document. Selecting Approve automatically grants Review permission; stakeholders must accept the organization invitation before assignment.
| Role | Permissions | Detail |
|---|---|---|
| Sponsor | Author · Reviewer · Approver | Build & maintain protocols, QA review remotely, e-signature approval. Full visibility across all CDMOs. |
| CDMO | Executor | Execute test protocols, record pass/fail results, capture evidence & screenshots, create deviations on failures. |
| Vendor | Author · Reviewer · Custom | Draft technical content, commission & qualify. Assigned per-document RACI with custom roles as needed. |
Tech transfer from sponsor to CDMO with full access control, data integrity, and regulatory compliance. Sponsor maintains a master library; Global Clone deploys to any CDMO in minutes; organization-level isolation and execution-only roles keep visibility and authoring under sponsor control.