Templates and governing context
Word or Excel templates, SOPs, policies and project sources
USE CASE · IT infrastructure qualification
Every instance checked — against the applicable baseline.
traqx prepares the qualification plan and protocols from policies, build SOPs and your configuration baseline — every instance matched deterministically, decided by ITQ and QA.
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THE RECURRING PATTERN
Your context becomes a reviewable document.
The work case uses the same controlled traqx logic as every other document use case.
Research, draft and edit natively
Sources, changes and open points stay connected in the work state.
IT infrastructure qualification
The expert reviews and decides; formal approval stays in the responsible process.
IT INFRASTRUCTURE QUALIFICATION
The platform carries every application. Its evidence stays scattered.
EU GMP Annex 11 separates it: the application is validated, the IT infrastructure is qualified. The evidence for the platform often lies scattered across build sheets, ticket histories and the knowledge of individual administrators.
TODAY
→
Wrong verb, wrong effort
IT infrastructure gets treated like an application or like equipment—every instance pushed through full test campaigns one by one. GAMP 5 takes a different route for Category 1.
CONTROL IN traqx
One type, many verified instances
traqx prepares the qualification of the platform type once; every instance is checked against the same baseline—qualified, not validated (GAMP Category 1).
TODAY
→
A baseline without a register
The configuration baseline lives in build sheets, scripts or the head of individual people; without a maintained register, the audit cannot show which state is the qualified one.
CONTROL IN traqx
Baseline as a maintained register
Building blocks, instances and configuration items are prepared as a versioned baseline from your policies, build SOPs and templates.
TODAY
→
Drift goes unnoticed
Patches and manual interventions alter instances gradually; without a match against the baseline, the deviation surfaces in the audit—or not at all.
CONTROL IN traqx
Deviation becomes visible
Every instance is deterministically matched against the qualified baseline; a deviation is flagged as a review case, not silently accepted.
Built for the AI requirements of EU GMP Annex 22: AI prepares the work, your experts review and decide — traceable in the audit trail.
THE CONNECTED EVIDENCE PATH
One ITQ case, evidenced end to end — from platform register to audit trail.
Five visible stations. One continuous work state.
01 · SOURCE SPACEBaseline and standards as the source space
Policies, build SOPs, protocol templates and the applicable configuration baseline are connected as controlled inputs — the standard for the platform type comes from your own register.
02 · PREPARATIONPlan, protocols and the baseline match
In the project view the agent structures plan and protocols for the platform type — every statement a source-bound suggestion that ITQ reviews before it enters the work state.
03 · WORD OUTPUTThe draft arrives as a Word file
Tracked changes in the familiar layout — ITQ keeps working in Word, not in a new system. The handover is a .docx that takes the familiar path.
04 · HUMAN REVIEWITQ and QA review and decide
Source and rationale comments sit on the change itself. ITQ and QA review the evidence and deviations and decide on a risk basis — formal approval remains in the leading QMS.
05 · AUDIT TRAILThe qualified state stays demonstrable
Who decided what and when is in the audit trail — filterable and exportable. When the auditor asks for the qualified state of an instance, the path to it is evidenced.
REVIEW CRITERIA
Useful only when the work state is reviewable.
No autonomous quality decision or formal release: traqx prepares document work; the accountable expert decides.
01
SourceGROUNDThe governing SOP, policy, template or project source stays connected.
02
StatusVERIFYProposals, open points and missing evidence remain distinguishable.
03
HumanDECIDEThe accountable expert reviews and decides in the responsible quality process.
OPERATIONS & SYSTEM FIT
traqx does not qualify any platform — formal approval remains in your QMS.
- Your QMS remains the leading systemtraqx prepares the qualification plan, protocols and baseline match and makes deviations visible. Formal approval remains in the leading QMS or another responsible system.
- The handover is a Word filePlan and protocols arrive as a .docx with tracked changes and source comments — they take the same release path as any other qualification document.
- Baseline and register stay with youYou decide what counts as the baseline; traqx prepares it as a versioned register from your policies, build SOPs and templates. EU-hosted; your documents are not used for model training.
DOCUMENT USE CASE · INCLUDED IN traqx
How does traqx support IT infrastructure qualification?
traqx connects infrastructure policies, build SOPs, protocol templates and the configuration baseline as controlled inputs. It prepares the qualification plan and protocols for the platform type and matches every instance deterministically against the qualified baseline. ITQ and QA review the evidence and deviations and decide; traqx does not qualify any platform.
How does software support IT infrastructure qualification?
EU GMP Annex 11 makes the distinction: the application should be validated and the IT infrastructure qualified. Software can connect the infrastructure inventory, qualified baselines and the documented comparison of each instance. traqx prepares that evidence chain from your released sources and shows what each statement rests on. IT and QA review and decide.
FAQ
Frame IT infrastructure qualification with traqx clearly.
Is IT infrastructure qualification included in traqx?
Yes. Document-based preparation of IT infrastructure qualification is a direct work case in traqx — with controlled sources, test steps and Word output.
What counts as GxP-relevant IT infrastructure?
Servers, network components, virtualisation, operating systems, databases and cloud platform services—the platform GxP applications run on.
Does traqx qualify the platform?
No. traqx prepares the qualification plan, protocols and baseline match and makes deviations visible. ITQ and QA review the evidence and decide; formal approval remains in the leading QMS.
ONE PRODUCT · ONE REAL DOCUMENT
Evaluate it on your own ITQ case.
In the personal live demo we clarify your template, governing SOP or policy and concrete task — and show the document workflow directly in the system.
Book your personal live demo
No obligation · personal · straight in the calendar