Turn every tech transfer into a disciplined, repeatable project — with clear ownership, full transparency, and a fixed project licensing fee designed for cost-controlled delivery.
Project-based. Full Platform. No Feature Gates.One project license. Every feature included. No named seats — every stakeholder has access at no additional cost.
Less effort vs. rebuilding validation docs from scratch
Illustrative — directional only
Manual TMX & execution admin cut when traceability is automated
Illustrative — directional only
Review and approval cycles shortened
Illustrative — directional only
To go-live on Express Implementation
Illustrative — directional only
Impact metrics are illustrative, based on typical digital validation efficiencies. They are directional only and not guaranteed performance commitments.
Everything You Need. One Project License.
Every feature is included in a single project license — no per-seat penalties, no feature gates, no hidden modules.
Clone complete validation packages and cross-pollinate transfer protocols and documents across organisations in seconds.
Requirements, risk assessments, and test results are linked automatically — eliminating manual traceability matrix effort.
Row-level security and project-scoped tenancy ensure CDMO environments are completely isolated from other sponsor projects.
AI generates protocol content with mandatory human review and e-signature before any record is finalised.
Live protocol execution with built-in deviation management, electronic signatures, and a complete, tamper-evident audit trail.
Unlimited stakeholder inclusion within a project: sponsors, CDMOs, CROs, and external reviewers — no seat count penalties.
Intelligent requirement development scoped to your system and regulatory framework, with mandatory human review.
Automated version control, change history, and e-signature workflows — all within the controlled project environment.
Global teams can collaborate in their preferred language within the same controlled, GxP-compliant environment.
From Initiation to Inspection-Ready Hand-off
Five structured phases — each with clear activities and measurable impact.
Project created, scope and regulatory framework configured, master data loaded.
Go-live in weeks instead of months
Existing packages globally cloned; CPPs, CQAs, and risk models defined in Valkit.
~70% less effort vs. rebuilding from scratch
CDMO runs protocols paperlessly with real-time deviations and e-signatures.
>80% manual TMX admin eliminated
Sponsors and QA review and approve in a shared, isolated project space.
Approval cycles shortened by up to ~50%
Complete, traceable record set exported for archive, submission, or QMS upload.
Inspection-ready on day one of hand-off
Two Parallel Workflows. One Controlled Environment.
Valkit MSAT manages both sides of the engagement — the sponsor initiates and transfers, the CDMO executes and delivers.
The sponsor initiates and transfers the validation deliverables
Create Project
Sponsor MSAT team creates a Valkit MSAT project and configures scope, regulatory framework, and master data.
Clone & Configure
Existing validated packages are globally cloned into the CDMO project. System name, location, and stakeholder assignments updated in minutes.
Invite CDMO
CDMO personnel are provisioned into the isolated project environment with role-appropriate permissions. No access to other sponsor projects is granted.
Assign & Review
Sponsors assign authoring, review, and approval roles. CDMO teams begin execution within the sponsor-defined validation structure.
The CDMO executes, delivers, and hands back a complete tech transfer record set
Execute Protocols
CDMO engineers MSAT execute test protocols directly in Valkit — paperlessly — with real-time deviation capture and e-signature at each step.
Manage Deviations
Deviations are logged, categorised, and resolved within the platform. The sponsor is notified automatically through the shared project environment.
Approve Records
Both CDMO and sponsor signatories review and e-sign documents within the same system — eliminating document couriering or PDF consolidation.
Hand-off Package
At engagement close, a complete, fully traceable validation record set is available for sponsor archive or regulatory submission — ready on day one.
Clear ownership across every stakeholder. This structure turns MSAT-led tech transfer into a disciplined, repeatable project instead of a document scramble.
Drives process strategy, risk models, CPP/CQA definition, and PPQ design directly in Valkit.
Owns quality decisions with full visibility from requirements and risk through to executed evidence.
Executes protocols in Valkit, with deviations, comments, and evidence captured at source.
Gets you live fast on a pre-validated platform, then supports high-velocity execution throughout the project.
Built for Regulated Environments
Valkit MSAT runs on the pre-validated R1125 'Odin' platform — complete with a validation package that includes VP, PRD, FRA, OQ, TMX, and VSR.
Electronic records and signatures aligned with major GxP expectations
Author, reviewer, executor, and approver role-based access control
Encryption at rest; TLS 1.3 in transit
Certified ISMS in place
Every collaborator included — no extra cost
EU–U.S., UK Extension, and Swiss–U.S. certifications active (U.S. DOC registered)
Valkit holds STAR AI ValidAIted certification — documenting security controls in AI-powered solutions, mapped to the Artificial Intelligence Controls Matrix (AICM) and assessed through AI-powered auditing.
Two Paths to a Fully Live Environment
2–4 weeks to live
Designed for organisations whose MSAT team is ready to own digital tech transfer and process validation directly. Valkit's onboarding team configures your CDMO project environment and trains your team to manage the platform from day one.
Via an approved Valkit delivery partner
Prefer to keep your team focused on the science? Contract an approved Valkit delivery partner to manage the entire tech transfer engagement on your behalf — every phase, entirely within the Valkit platform.
Partner regions: US · UK · EU · India · APAC
One Price. One Project. One Engagement.
Covers the full duration of your tech transfer — scoped per project. No per-seat fees. No overage charges. Predictable spend from kickoff to sign-off.
One-time implementation fee + your choice of delivery model
Express
One-time implementation fee paid at project kick-off. Covers onboarding, platform configuration, package cloning, user provisioning, and sponsor team training. Your team manages the platform.
Managed
Recurring fee based on your approved partner's geography, capability level, and engagement utilisation. Partner manages the engagement end-to-end within the Valkit platform.
Contact [email protected] for demo and pricing.
Impact metrics on this page are illustrative and directional only. They reflect typical efficiencies seen in digital validation programmes and are not guarantees of outcomes for any specific engagement.