Templates and governing context
Word or Excel templates, SOPs, policies and project sources
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USE CASE · INCLUDED IN traqx
Included · no module feeIT infrastructure qualification
Prepare qualification documentation across infrastructure types and instances.
HUMAN REVIEWOpen · expert decision required
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.
IT INFRASTRUCTURE QUALIFICATION IN traqx
From platform inventory to a verified instance state.
Your infrastructure policies, build SOPs and configuration baseline set the standard. traqx structures the qualification plan, protocols and the per-instance match.
- 0101 · GROUND
Connect platform inventory and baseline
Building blocks, instances and configuration items, along with the applicable configuration baseline, are connected from your register.
Result · defined qualification context - 0202 · GENERATE
Prepare qualification plan and protocols
traqx structures the plan and protocols for the platform type from policies, build SOPs and templates as a source-bound proposal.
Result · reviewable qualification draft - 0303 · VERIFY
Match instances against the baseline
Every new or changed instance is deterministically checked against the qualified baseline; deviations are flagged as review cases.
Result · evidenced or open match - 0404 · REVIEW
Review and decide professionally
ITQ and QA review the evidence and deviations and decide on a risk basis. Formal approval remains in the leading QMS or another responsible system.
Result · human decision
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.
The governing SOP, policy, template or project source stays connected.
Proposals, open points and missing evidence remain distinguishable.
The accountable expert reviews and decides in the responsible quality process.
AI preparesresearch · drafts · updates · candidate traces
Experts verifycorrectness · correction · acceptance · decision
traqx makes visiblesource · status · change · review path · audit trail
Customer data stays protectedagreed tenant and hosting scope · no model training on customer data
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.
FAQ
Frame IT infrastructure qualification with traqx clearly.
Is IT infrastructure qualification included in traqx?
Yes. Document-based preparation of IT infrastructure qualification is part of traqx and carries no separate module fee.
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
Clarify this use case for your document.
In the 15-minute introductory call, we clarify your template, governing SOP or policy and concrete task. If a product walkthrough is the right next step, we arrange it separately.
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