Solutions
Technology transfer, in one governed workspace
A transfer runs 12–24 months across two companies, hundreds of documents, and a quality system that has to hold up under inspection. ColabFlo’s Tech Transfer solution combines Project, Document, and Quality Management into a single transfer thread where the CDMO and the sponsor work from the same record.
What lives in a transfer project
Structure a transfer the way you actually run it — by stage (feasibility, tech transfer, engineering runs, PPQ, validation, commercial readiness) or by your own WBS. Tasks and milestones carry owners on both sides. The sponsor sees status without a status call.
The document lifecycle, enforced
Every document type you use — MBR, analytical method, validation protocol, transfer protocol, SOP, report — with its own lifecycle, its own approval chain, and its own template. Documents are drafted in-platform, routed for review, approved with e-signature, released, and superseded on a controlled path. Prior versions stay retrievable; the current version is never in question.
Quality events that know their context
When a deviation is raised during an engineering run, it’s raised inside the transfer, against the document or step it relates to. NCRs, CAPAs, change controls, and investigations follow the states your quality system defines, with escalation timelines and QA review gates. When the auditor asks what happened and what you did about it, the chain is already assembled.
One evidence trail
The sponsor’s view
Sponsors get scoped access — the programs that are theirs, the documents shared with them, the events they need visibility into. No shared logins, no exported PDFs, no separate portal to maintain.
Configure it to your process
Types, statuses, and workflows are yours to define — brought into the workspace by your administrators, not hardcoded by ours. Ask us to configure one live on the demo.
FAQ
How is this different from our project management tool?
PM tools track tasks. They don’t enforce controlled document lifecycles or link quality events to the exact document version that caused them — under the same permission and audit model.
How is this different from our eQMS?
eQMS systems manage quality workflows well, but usually sit apart from the transfer project and its documents. ColabFlo keeps the quality event inside the same object graph as the work.
Does this replace our EDMS?
It can be the system of record for transfer-related controlled documents. Many teams keep enterprise EDMS for site-wide SOPs and use ColabFlo for the transfer corpus — your configuration decides the boundary.
How do sponsors get access, and what can they see?
Sponsors receive scoped access to the programs that are theirs — documents shared with them and events they need visibility into. No shared logins; enforcement is by tenant and role.
What is your Part 11 position?
ColabFlo is architected to support 21 CFR Part 11 requirements through audit trail, e-signature, and access-control technical controls. See the Trust page for the status table. Validation for intended use remains your responsibility.
How long does implementation take?
Founding partners configure document types and quality workflows with the people who built the platform. Timeline depends on how many types you bring; we configure live in demos so you can see the path early.
Can we import existing documents?
Import paths are expanding with founding partners. Bring your corpus shape to the demo — we’ll be explicit about what ships now vs. next.
What integrations exist today?
We prioritize depth in the core object model before a wide integration catalog. Ask on the demo for the current connector list and roadmap.