Process validation · CPV
Process validation with end-to-end evidence logic.
Plan, protocol and report take shape along your process requirements — parameters, criteria and evidence visibly linked.
Relevant to EU-GMP Annex 15 and ICH Q8–Q10.
- Justify criteria from sources.
- Connect Stage 1 to 3 traceably.
- Assessment stays with your team.
Process validation lifecycleFDA 3-stage · ICH Q8–Q10
Critical parameters derived from sources · each evidenced
Why process validation gets expensive later
It's not the process that costs you time. It's the missing source logic.
Process validation connects many layers: process understanding, parameters, sampling, acceptance criteria, deviations and reports. Without clear source logic, every change later becomes expensive — because no one can cleanly show anymore why a criterion was chosen that way and which evidence supports it.
01
Acceptance criteria without traceable origin
Why exactly this limit, this sampling scheme, this sample size? If the rationale lives only in heads or scattered across old reports, every question in review becomes a search task.
02
Plan, protocol and report drift apart
Validation plan, protocol and report repeat the same substance in several formats. Every inconsistency between them — a different parameter, a shifted criterion — is an audit finding in waiting.
03
Every change pulls an expensive wave behind it
If a critical parameter shifts, acceptance criteria, sampling and evidence have to be brought along. Without visible linkage it is easy to overlook what else is affected.
How traqx models your process validation
traqx builds up plan, protocol and report — along your process requirements.
traqx helps build validation plans, protocols, reports and evidence logic along your process and quality requirements. The core principle always stays the same: Policy → SOP → Template. No templates of your own yet? You start with our best-practice templates. Generate · Verify · Monitor, from process definition to approval logic.
Why this holds up in an audit
The AI drafts. You own it.
The AI output is never silently written into a validated dataset. Until you approve it, every suggestion stays a suggestion — and only your confirmation makes a dataset true.
By construction
What a process validation structurally safeguards.
Acceptance criteria
source-bound
From parameter to report, every criterion carries its source and its evidence — clickably traceable, confirmed by a human. Better traceability between process knowledge, criterion and documented decision.
1 → N
evidence linkage
One process parameter, linked through from the source via the acceptance criterion to the evidence in the report. If the parameter changes, what needs to be brought along becomes visible — instead of catching up expensively later.
0
silent AI writes
No derived parameter and no criterion lands without human approval in the dataset. By construction — not by discipline. So you go into QA review and inspection better prepared.
Available today when customer-side process requirements and templates are in place. Statistical assessment and final QA decision stay with the responsible team. We publish real time or cost effects only with robust pilot or case-study data.
Questions from practice
Common questions on process validation & CPV
What is Continued Process Verification (CPV)?
Stage 3 of FDA process validation: the ongoing, documented evidence that the process remains in its validated state — via trends of critical quality attributes and process parameters, assessments and periodic reports. CPV does not end while the process runs.
How do process validation and CPV differ?
Process validation (Stage 1: process design, Stage 2: process qualification) initially evidences that the process is under control. CPV (Stage 3) maintains that evidence in routine operation. Both belong to one lifecycle — treated separately, they create exactly the gaps inspectors find.
Which data belongs in a CPV programme?
Critical quality attributes (CQA) and critical process parameters (CPP), their trend analyses, deviations and actions, and periodic assessment reports. The connection is what counts: from measurement through assessment to the approved report.
Can CPV documentation be automated?
The drafting, yes: AI creates report drafts from controlled data sources, every statement source-bound. Assessment, decision and approval remain attributable to your team — what gets automated is the assembly, not the responsibility.
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
Start with one process.
Bring a real process validation along to the demo — one process, one product family, exactly the source logic that is missing today. First structured drafts (plan, critical parameters, acceptance criteria) appear early in the first process; we set concrete time targets together before the start.
No sales pitch — a short conversation around your concrete process validation scope. We define success criteria in writing before the start; the documented assessment is yours even if you say no afterwards. EU-hosted, no model training, source room deleted on request with evidence.