Valkit.ai launches Greenfield commissioning platform for new sites

By AI, Created 4:10 AM UTC, May 25, 2026, /AGP/ – Valkit.ai unveiled Valkit Greenfield, a paperless, AI-augmented commissioning and qualification platform for greenfield facility builds, on June 1, 2026. The project-based system is aimed at helping life sciences teams start new sites faster with shared workflows, no per-seat fees and certified partner delivery.

Why it matters: - Valkit Greenfield is designed to replace the document-heavy startup process for new manufacturing sites with a single, shared digital environment. - The platform targets pharmaceutical, biotechnology and healthcare teams that need commissioning and qualification work done faster and with fewer manual handoffs. - The pricing model removes per-seat fees and overage charges, which could lower cost barriers for large project teams.

What happened: - Valkit.ai launched Valkit Greenfield on June 1, 2026. - The product is a digital commissioning and qualification system built for new site start-up. - Valkit Greenfield runs on Valkit’s pre-validated R1125 “Odin” platform. - The launch was announced from Indianapolis. - The product is delivered exclusively through Certified Valkit Greenfield Partners.

The details: - Valkit Greenfield gives owner, engineering, vendor and contractor teams one isolated project environment to author, execute and close out IQ/OQ/PQ work. - The platform is project-based and allows unlimited collaboration with no named seats and no access gates. - Protocols are authored, version-controlled and distributed from isolated libraries, then cloned and customized to the project scope. - Execution guardrails prevent skipped steps and enforce evidence capture at every test step. - Deviations are logged, categorized and resolved in the platform, with automatic notifications to all parties. - AI assists with plan, specification, protocol and test-case drafting, but every output requires human review and e-signature. - Automated risk assessments, trace matrices and summary reports connect requirements to test evidence end to end. - Customers can go live in 2 to 4 weeks through Express Implementation. - Valkit’s onboarding team configures the project environment and trains the customer team to run the platform directly. - Fully managed engagements are also available for organizations that want to keep internal teams focused on the science. - Valkit said only Certified Valkit Greenfield Partners are authorized to deliver those managed engagements. - Valkit said it works with large C&Q engineering firms across the United States, United Kingdom, European Union, India and Asia Pacific. - Each certified partner can manage planning, execution, deviation management and sign-off within the platform. - Each engagement includes a validation plan, product requirements document, functional risk assessment, operational qualification, trace matrix and validation summary report at no additional charge. - The pricing structure is a fixed project license fee. - Customers receive a traceable qualification record set at project close, with true-copy PDF export to an eQMS or legacy DVT. - Most customers treat Valkit as a GAMP Category 1 or Category 3 tool. - The platform includes 21 CFR Part 11 and EU Annex 11 electronic records and signatures, role-based access control, AES-256 encryption and a certified ISO 27001:2022 ISMS.

Between the lines: - Valkit is positioning Greenfield as the next step in a broader push to move validation work from spreadsheets and shared drives into a controlled software workflow. - The certified-partner model suggests Valkit wants to scale delivery without giving up process consistency across regions. - The launch also extends a product portfolio that already includes CSV, CSA, C&Q and MSAT-led tech transfer tools. - The company is using its rapid growth and security credentials as proof points for the new offering.

What’s next: - Valkit said active projects are projected to exceed 2,000. - The company will continue delivering Greenfield engagements through certified partners or through its Express Implementation model. - Customers adopting the platform will likely use the generated qualification package as the basis for inspection-ready records and downstream system handoff. - More information