Structured risk clarity for engineering validation teams — advisory and decision‑support.
KRPN modelling • PTMS workflow insights • Engineering decision‑support
Structured risk clarity for engineering validation teams — advisory and decision‑support.
KRPN modelling • PTMS workflow insights • Engineering decision‑support
TraceFlow™ gives engineering and quality teams clearer process understanding by organising parameters/settings, interpreting risk, and highlighting drift across equipment and lifecycle stages.
Teams gain:
Clearer risk interpretation
Stronger parameter/setting organisation
Early drift‑warning signals
More defensible decisions
Reduced validation noise and workload
TraceFlow™ combines advisory consultancy with two proprietary digital systems — PTMS for parameter/setting traceability and KRPN for structured risk scoring.
TraceFlow™ KRPN Solutions — Overview
Advisory consultancy for regulated manufacturing, supported by emerging digital tools that strengthen risk interpretation, parameter/setting lifecycle understanding, and structured decision support.
We support engineering and quality teams with Professional validation guidance, modern process‑risk modelling, and early‑stage digital traceability concepts now entering pilot evaluation.
TraceFlow™ provides specialised validation advisory consultancy and develops next‑generation digital tools designed for regulated manufacturing.
We help engineering and quality teams:
Interpret process risk more clearly
Organise and map parameters/settings across equipment and processes
Understand drift patterns and early‑warning indicators
Make structured, defensible decisions aligned with lifecycle expectations
Our pilot evaluations explore new quantitative approaches to process‑risk interpretation and parameter behaviour, including prototype KRPN™ scoring.
CQV Advisory Support
Process Validation Advisory
Process Risk Modelling
Parameter/setting Mapping & KRPN Scoring
Process Drift & Troubleshooting
CQV Advisory — €85/hr
Process Validation Advisory — €90/hr
Parameter/setting Mapping & KRPN — POA *
Validation Compliance Review — POA*
Process Drift Analysis — POA*
*(per equipment parameter set)
Onsite Advisory
For physical presence, workshops, investigations, and client‑site support.
Half Day (onsite) — €500
Full Day (onsite) — €900
Travel mileage and accommodation (if required) are charged separately.
1 x Equipment — €250–€450/month
2 x Equipment — €600–€1,200/month
Add‑ons — €150–€300/month “Note: Prices may vary depending on complexity.”
Includes digital parameter mapping, prototype KRPN scoring, dashboards, and monthly remote advisory reviews.
Consultancy + MVP + Monitoring — POA
Basic — €300
Standard — €500
Premium — €900
All pricing is quoted exclusive of VAT. View full Pricing
Pharma • MedTech • Biotech • Food Manufacturing • Regulated Production
See Industry Use Cases
With 11+ years of experience, TraceFlow™ combines deep industry knowledge with innovative digital development to strengthen lifecycle understanding and support structured decision‑making.
Advisory Consultancy • Pilot Evaluations • KRPN Development • PTMS Prototyping
Start a project: Contact TraceFlow