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On-site Quick Check: know where you stand first

One to three days at your site, checking the current state on the ground. You then receive a report with prioritized actions and a proposal for the next step.

Request a Quick Check

Who is the Quick Check for?

For heads of QA, production and engineering who have a project ahead: an inspection, an ISO 13485 certification, a validation, a lab redesign, an investment in the plant. Before it becomes a project, you want to know where you stand today and which step makes sense next.

How does the Quick Check work?

Initial call and proposal

You describe your project and your starting point. You then receive a proposal with scope and a fixed price.

Remote preparation

We review your documents in advance so that we can check in a targeted way on site.

One to three days on site

Usually two. We capture the current state on the ground and name weak points and improvements you can implement quickly.

Report and review

You receive a report with prioritized actions, and we go through the results with you.

Proposal for the next step

On request, you receive a project proposal with a roadmap and an effort estimate. Whether a project follows is your decision.

Pricing: Fixed price after an initial call

Which topics does the Quick Check cover?

Each card leads to the service page and names where the work there begins.

QMS and certification for MedTech

Gap analysis against ISO 13485:2016: where your QMS stands, what is critical and what is a matter of effort.

To the service page →

GMP and audit

GMP audit of production sites and contract manufacturers against the EU GMP Guidelines and 21 CFR Part 211, with an audit report and classified findings.

To the service page →

Inspection

Readiness assessment and gap analysis: where documentation, data integrity and CAPA status stand against GMP, and what is critical before the inspection.

To the service page →

Manufacturing performance

Lean diagnosis and value stream capture: a current-state value stream map of the production area with named waste potential.

To the service page →

Plant, equipment and investment

Needs assessment and business case: capital requirements, an options comparison and the regulatory consequences as a decision document.

To the service page →

Supply chain and planning

Chain assessment: where your supply chain stands relative to the EU GMP Guide and the EU GDP Guidelines, and where cost, efficiency and supply risks lie.

To the service page →

Lean lab and OpEx

Lean lab assessment with value stream analysis: quantified waste per laboratory area and a prioritized action list.

To the service page →

Validation, CSV and data integrity

System assessment: system inventory with GxP criticality and GAMP 5 category per system, with the validation scope derived from it.

To the service page →

Tech transfer

Gap analysis between the donor and receiving site: a prioritized gap list across technology, analytics, documentation and regulatory affairs.

To the service page →

Request a Quick Check

Briefly describe your project and the topic. We will get back to you for the initial call, usually within one business day.

Prefer direct? +39 02 8904 1000
contact@theentourage.it

  • Reply usually within one working day
  • 4 locations: DE · CH · IT · US
  • 100% life sciences