Define sources
Policies, SOPs, templates, project files and relevant external requirements form the controlled context.
WHO IT IS FOR · ORGANISATIONAL FIT
AI for life sciences quality teams: where traqx fits.
traqx fits pharmaceutical, medical device, biotech, CDMO/CMO and CRO quality teams when traqx is used to prepare research, drafts, document updates and traceability from controlled sources before their subject-matter experts review the result. traqx does not replace an eQMS, DMS, QMS, MES, CTMS or another system of record, and it makes no autonomous quality or release decision.
YOUR WORKING REALITY
Choose the organisational context you are responsible for.
Each page starts from different work objects and boundaries. The product logic stays the same; an industry label does not create a new capability.
01 · Pharma
Keep SOP changes, validation documents and audit evidence connected.
For quality teams working across distributed controlled sources with clear QA responsibility.
02 · Medical devicesFrame QMS documents, technical documentation and software assurance.
For QA/RA teams, without implying replacement of an eQMS, RIM or design-control system.
03 · BiotechControl growing document sets and the move into GxP-relevant work.
For the actual regulated scope, not automatically for every research activity.
04 · CDMO / CMOKeep client, site and process requirements as distinct source sets.
For the provider perspective, with clear system and responsibility boundaries.
05 · Contract research organization (CRO)Separate SOP, quality, validation and audit work from trial operations.
For quality work in the applicable scope; not as a CTMS, eTMF or EDC replacement.
SHARED MECHANISM
Different industry. The same controlled division of work.
traqx prepares work inside the defined source room. Professional assessment, correction and decision remain with the responsible expert.
Prepare groundwork
traqx researches inside the source room and prepares drafts, document updates and traceability suggestions.
Check evidence
Source, section, status and open points remain visible and reviewable on the work object.
Decide as a human
Experts review, correct, accept or reject; the existing release process remains authoritative.
Policies, SOPs, templates, project files and selected external requirements form the bounded context.
Research and cite inside a controlled source room, update documents and prepare traceability candidates.
Assess sources, suggestions and open points; the existing release process remains authoritative.
FAQ
Assess organisational fit clearly.
Which regulated life sciences quality teams is traqx a fit for—and where is the product boundary?
traqx fits pharmaceutical, medical device, biotech, CDMO/CMO and CRO quality teams when traqx is used to prepare research, drafts, document updates and traceability from controlled sources before their subject-matter experts review the result. traqx does not replace an eQMS, DMS, QMS, MES, CTMS or another system of record, and it makes no autonomous quality or release decision.
Which agent and Word tasks are already part of traqx?
traqx researches and cites inside controlled source rooms, prepares drafts and traceability candidates, and can return existing documents as Word files with tracked changes, source or rationale comments and an updated version history. The expert reviews and decides. A separate GxP module only becomes relevant when a recurring process also needs a preconfigured method, templates, work objects and a review path.
Which responsibility stays with the accountable expert?
The expert checks sources, corrects or rejects the groundwork, assesses open points and decides through the existing quality and release process. traqx does not set a draft to released autonomously.
Does every activity in a life sciences company have to be GxP-relevant?
No. The actual process and regulatory context decide. Especially in biotech, medical devices and CROs, traqx does not infer a blanket GxP classification from the industry label.
Do existing quality or document systems have to be replaced?
No. Depending on the architecture, traqx can work as a standalone platform or connect to an existing system landscape. Forced replacement of an eQMS, DMS or another system of record is not part of the proposition.
ORGANISATIONAL FIT IN THE MEETING
Show us one real quality process.
We show the controlled source room, concrete agent task, reviewable result and system boundary on your quality process.
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