CDMO / CMO · DOES IT FIT US?
traqx prepares documents, answer drafts and evidence per client project inside a clearly bounded source scope — conflicts between client and site requirements stay visible instead of being silently merged. Your experts review and decide.
No obligation · personal · straight in the calendar
WHAT YOUR TEAM GAINS
THREE CONCRETE SITUATIONS
Client, site and process sources stay visibly separate — responsibility and release remain with the organisations involved.
CONTROLLED WORKING MODEL
traqx prepares work inside the defined project — client and contractor responsibilities remain clearly assigned outside the software.
Quality agreement, client documents, site SOPs, templates and external requirements — assigned to the work object.
traqx researches inside the defined source room and creates reviewable groundwork for each work package.
Evidence passages and conflicts stay visible; client and site requirements are not silently merged.
Accountable experts review within the agreed quality process — on the provider and, where needed, client side.
FIT / BOUNDARY
This page addresses only the CDMO/CMO's own quality process, not the sponsor view of contractor oversight.
Sources can be bounded per work object, the provider remains accountable for review and decision, and traceable groundwork is needed across multiple requirements.
traqx promises neither a customer portal nor cross-project control and does not transfer client or contractor responsibility.
EVIDENCE, NOT A MARKETING CLAIM
traqx is EU-hosted and works in controlled source rooms; customer documents stay within the agreed tenant and hosting scope and are not used for model training. Experts review and decide. The product dossiers show real system views with synthetic demo data—not CDMO/CMO customer outcomes.
VISIBLE PRIMARY SOURCES
Chapter 7 addresses outsourced activities and the written definition and control between contract giver and contract acceptor. This page infers no transfer of responsibility to traqx from it.
The official collection places Chapter 7 in the EU GMP framework. Which activity and site are actually affected remains a customer scope question.
FAQ
traqx fits provider-side work at a CDMO or CMO involving client requirements, quality agreements, internal procedures, SOPs, validation records and audit evidence within a defined project and source scope. traqx does not replace a QMS, MES or customer portal and does not transfer quality responsibility to the software.
No. This page promises neither cross-project control nor a customer portal. Every use case shown works within one defined project, source room and work object.
Sources are assigned to the concrete project and work object with their respective provenance. Answer drafts, conflict lists and document updates retain those links; unresolved priorities are identified as open points.
No. Contractual and regulatory responsibilities remain with the involved organizations and their quality process. traqx prepares source-bound work and makes open points visible.
FRAME THE PROVIDER PROCESS
We check source separation, agent task, review, project scope and system boundary on one real work object.
No obligation · personal · straight in the calendar
