Suppliers · EU GMP Chapter 7 In development
Keep supplier status visible.
Criteria, documents, gaps, decisions and requalification deadlines come together in one controlled workflow logic.
Relevant to EU-GMP Chapter 7 and ICH Q10.
- No hunting for evidence in email threads — the record stands in one place, not spread across scattered attachments.
- Link criteria and documents visibly — which document evidences which criterion stays traceable; open gaps remain visible.
- No automatic supplier approval — every qualification decision stays human-owned and justified.
Supplier lifecycleEU-GMP Ch. 7 · ICH Q10
Qualification criteria loaded source-bound · planned, in preparation
Why supplier qualification is so laborious
The qualification is clear. The evidence is scattered.
Which criteria apply, which documents are on file, what is still missing, who decided what — the answers sit in emails, attachments and people's heads, not in one verifiable place. The more suppliers, scopes and sites are involved, the harder a consistent, traceable record becomes.
01
Evidence lives in emails and attachments
Certificates, audit reports and questionnaires arrive via scattered email threads. In the audit the right version is assembled by hand, attachment by attachment — late and error-prone.
02
Criteria and documents are not linked
Qualification criteria sit in the standard, the delivered documents elsewhere. Which document covers which criterion — and where a real gap remains — has to be derived anew every time.
03
Decisions without continuous evidence
Queries, approvals and requalification deadlines run through people and inboxes. If the person leaves, the rationale is missing — and the thread to the decision can no longer be cleanly evidenced in the audit.
How traqx should map your supplier qualification
One continuous thread — from scope to requalification.
The planned flow follows the same traqx core principle as everywhere: Policy → SOP → Template. From your qualification SOPs and criteria catalogues, documents should be pre-structured, gaps made visible and decisions kept traceable — Generate · Verify · Monitor. In preparation: the steps below show the planned discipline we work on together with early partners.
Why this should hold up in the audit
The AI pre-checks. You stay accountable.
When planned too, the traqx fundamental law applies: no AI output is silently written into a validated record. Until your approval, every proposal stays a proposal — only your confirmation makes a qualification decision true.
By construction
What a supplier workflow should structurally secure.
Criterion → evidence
linked
Every criterion should be linked to the document that evidences it — or stay visible as an open gap. Instead of assembling evidence from emails, the reference sits in one place.
0
silent approvals
No supplier and no mapping should become valid without human approval. By construction — not by discipline. This way you go into QA review and inspection more prepared.
1 thread
scope to requalification
Scope, criteria, documents, gaps, queries, decision and deadline should hang on one continuous thread — traceably linked and reviewable.
Supplier qualification is in preparation — not yet available; the value and workflow above are planned. The properties named describe what the discipline should secure by construction — no guarantee of an audit outcome, but better preparation. We publish real time or cost effects only with reliable pilot or case-study data.
Questions from practice
Common questions on supplier qualification
What does supplier qualification in GxP comprise?
Risk-based assessment before the collaboration, audits or questionnaires depending on criticality, quality agreements, ongoing performance monitoring and periodic requalification. The evidence must show: you know your suppliers and actively manage the risk.
When is a supplier audit required?
Risk-based: for critical materials and services an on-site audit is the standard; for lower risk, questionnaires or desk audits can suffice. Frequency and depth follow from criticality, history and previous findings — documented in your risk assessment.
What is a quality agreement?
The contractual definition of GMP responsibilities between contract giver and supplier — who owns what, who informs whom about changes and deviations. EU GMP Chapter 7 makes it mandatory for outsourced activities.
How does AI help with supplier assessment?
It consolidates evidence — certificates, audit reports, questionnaires — and drafts assessments with source binding, instead of letting records disappear into email loops. Deadlines and requalifications stay tracked; your team assesses and approves.
More disciplines
One platform, many use cases.
Same trust architecture — sources first, AI as a suggestion, human decides, audit trail stays — across every GxP discipline.
Security & standards · built for traceable evidence
Founded by CSV experts with 15+ years of domain expertise
Help shape this use case from the very start.
Supplier qualification is in preparation — and right now is the perfect moment to shape the workflow on a real GxP supplier scope. Bring in a real qualification case; we define frame, criteria and time targets together before the start.
No sales pitch — a short conversation around your concrete supplier scope. Supplier qualification stays clearly marked as a roadmap use case; the assessment is yours even if you say no afterwards. Source room deleted on request with evidence.