Project-based commissioning and qualification — paperless execution, AI-augmented authoring, zero GDP errors. Built for pharmaceutical, biotech, and medical device site start-ups.
Less Document Build Effort
Reduction in Manual TMX Effort
QA Review Time Reduction
GDP Errors
All impact metrics are directional only and based on typical digital validation efficiencies. Not guaranteed performance commitments.
Built for GREENFIELD Site Start-Up
Unlimited collaboration across owner, engineering, and execution teams — no named seat fees.
Create Project
Configure scope, regulatory framework, master data, and library link for the GREENFIELD engagement.
Clone Templates
Pull best-practice IQ/OQ/PQ templates from the isolated library. Customise in minutes.
Provision Teams
Assign roles to internal engineers, third-party vendors, and contractors — all at no additional cost.
Assign & Review
Approve authored documents and delegate execution. Real-time visibility across all workstreams.
Execute Paperlessly
All teams run IQ/OQ/PQ protocols directly in Valkit. Guardrails prevent skipped steps. Evidence is captured and enforced at every test step.
Manage Deviations
Deviations logged, categorised, and resolved within the platform. All parties notified automatically.
Approve & E-Sign
Reviewers and approvers sign within the same system. No PDF consolidation. No document couriering.
Close & Export
A complete, traceable qualification record set is produced. Export true-copy PDFs to your eQMS or legacy DVT at project close.
From Ground-Break to
Qualified Facility
Five phases. One platform. Full traceability from commission intent to validated operation.
Project created. Regulatory framework, master data, and library templates configured.
Go-live in weeks, not months
AI-assisted URS, FDS, and risk assessment authoring. Requirements linked from day one.
~70% less document build effort
IQ/OQ/PQ protocols authored with AI assistance. Automated trace matrix generated continuously.
>80% reduction in manual TMX effort
Paperless test execution with real-time deviation capture, evidence enforcement, and e-signature at every step.
GDP errors: eliminated
AI-assisted post-execution evidence review. Summary report generated. Documents exported or uploaded to eQMS.
QA review time reduced by up to 90%
30–40% reduction in contractor headcount assumes fully managed delivery via a Certified Valkit GREENFIELD Partner. Directional only. Not a guaranteed performance commitment.
Valkit GREENFIELD reduces the resource burden at every phase while improving data integrity and auditability.
Execution Guardrails
Steps cannot be skipped. The platform enforces sequence, preventing the class of deviation caused by forgotten test steps.
Enforced Evidence Capture
Evidence requirements are defined at authoring. Execution cannot proceed without the required evidence attached.
GDP Error Elimination
Free-text data entry controls, timestamps, and audit trails eliminate the most common categories of Good Documentation Practice error.
AI-Assisted Evidence Review
Post-execution AI analysis of captured evidence and test results reduces QA protocol review time by as much as 90%.
Plan & Specification Authoring
AI drafts URS, FDS, and validation plans from master data context. Human review and e-signature required before any record is finalised.
Protocol & Test Case Authoring
AI generates IQ/OQ/PQ protocol content and step-level test cases aligned to defined risk and requirements.
Automated Risk Assessments
Risk registers drafted and linked to requirements automatically. Teams review, amend, and approve — not build from scratch.
Automated TMX & Summary Reports
Trace matrices and validation summary reports generated continuously. No manual assembly. Inspection-ready on demand.
All AI-generated content requires mandatory human review and e-signature before any record is finalised. AI functionality is entirely optional and can be disabled.
Pre-Validated Platform.
Inspection-Ready from Day One.
21 CFR Part 11
Electronic Records & Signatures
EU Annex 11
Compliant Electronic Records
RBAC
Author / Reviewer / Executor / Approver
AES-256
Encryption at rest, TLS 1.3 in transit
ISO 27001:2022
Certified ISMS in place
No Named Seats
Every collaborator included, no extra cost
Runs on the Pre-Validated R1125 'Odin' Platform
Validation package — VP · PRD · FRA · OQ · TMX · VSR — delivered to every customer at no additional charge.
Validation Plan
Strategy, scope, roles, acceptance criteria & regulatory framework
Requirements
Platform functions mapped to 21 CFR Part 11, Annex 11 & data integrity
Functional Risk Assessment
Risk-rated requirements driving test depth
Operational Qualification
Pre-approved, risk-based test protocol executed against production environment
Trace Matrix
Bidirectional linkage from every requirement to every test case
Validation Summary Report
Post-execution summary of all activities, outcomes and deviations
Two Paths to a Fully Live,
Qualified Environment
Option 01
2 – 4 Weeks to Live
Designed for engineering teams ready to own digital commissioning and qualification directly. Valkit's onboarding team configures your project environment and trains your team to manage the platform from day one.
Option 02
Global C&Q Partner Network
Prefer to keep your team focused on the science? Contract an approved Valkit delivery partner to manage the entire commissioning and qualification engagement on your behalf — entirely within Valkit.
Partner Regions: United States · United Kingdom · European Union · India · Asia Pacific
One Price. One Project.
One Engagement.
Covers the full duration of your commissioning and qualification project — scoped per engagement. No per-seat fees. No overage charges.
Paid once at project kick-off. Covers onboarding, platform configuration, template cloning, user provisioning, and team training.
One price. One project. Covers the full duration — scoped per project. No per-seat fees. No overage charges. Predictable spend from kick-off to sign-off.
Recurring fee if using an approved Valkit delivery partner. Based on partner geography, capability level, and engagement scope.