CAPA, change control and audit readiness that work on the floor rather than in a binder: GMP consulting with execution on site, risk-based to ICH Q9. From Visp in Valais, across Switzerland.
A QMS only carries weight when its processes are lived daily. We work where the quality system meets the plant. Our field:
Every service ends in an audit-ready document, not a recommendation. What you get:
We check your system against the relevant chapters and annexes and rank findings by risk, not checklist length.
Outcome: a prioritised action plan with owners and dates.
Root-cause analysis instead of symptom control: human error is a symptom, rarely the root cause. Actions with effectiveness checks.
Outcome: closed CAPAs that demonstrably prevent recurrence.
Changes to equipment and systems assessed against qualification status, validation and documentation before they happen.
Outcome: changes that preserve the validated state instead of eroding it.
Documentation, rooms and people prepared: mock rounds, question lists, audit roles, support during the inspection.
Outcome: a team that answers in the audit instead of searching.
SOPs and records that are lean, unambiguous and usable day to day, written with the people who work with them.
Outcome: documents that get read, not just revised.
Assessment of digital tools and AI applications in the quality environment, risk-based and with a view to the draft Annex 22.
Outcome: a documented, reasoned assessment instead of gut feel.
Gap analysis against the relevant regulations, findings ranked by risk.
Actions with owners, dates and effort estimates, aligned with your QA.
We execute with you: SOPs, CAPA, change control, training, at the plant, not just in the meeting room.
Effectiveness checks and metrics show the actions hold.
Periodic review and lived processes keep the system current.
We do not deliver slide decks; we work the actions off with you, on site in running GMP operations.
We come from the plant. CAPAs and changes are assessed technically, not just administered formally.
ICH Q9 is our working principle: effort where product and patient are protected.
Every requirement is traceable through to its test evidence. That is the standard we hold ourselves to.
Yes, with one difference: GMP consulting with execution. We do not just analyse; we work the actions off on site in running GMP operations, from SOP to effectiveness check.
Yes: gap analysis, mock rounds, role clarity and document readiness, on request with support during the inspection and in responding to findings.
As a symptom, not a root cause. We look for the condition that made the error possible, in process, design or documentation, and place the action there.
In yours. We strengthen the existing system rather than putting a second one next to it; where gaps exist, we close them within your structure and document world.
With a 30-minute, no-obligation first call. Then the gap analysis, from which a prioritised action plan follows. Reply within one working day, straight from engineering.
In the initial conversation we place your starting point: 30 minutes, no strings attached. Reply within one working day, straight from engineering.
Book an initial conversationSee all services