Plant and process engineering, qualification and validation, CSV and data integrity, quality and QMS, project leadership and management: five pillars, delivered on site in live GMP operations, with audit-proof documentation and an audit-ready handover.
Fig. 01 · Verification with checklist
Illustrative image
Plants, processes and utilities: planned, supported and improved across the entire lifecycle. We work directly at the equipment, aligned with production and QA, so that projects land in operations.
From the concept phase to a handover ready for operation: we plan new builds and modifications and support execution where it is decided, at the equipment.
Designing, adapting and stabilizing processes: technically sound, risk-assessed and documented so that every change remains traceable.
PW/WFI, HVAC and cleanroom air, compressed gases: we plan and maintain the supply systems that every GMP production depends on.
We plan modifications and expansions in GMP operations so that production and the qualified state remain protected, coordinated with operations, QA and maintenance.
Qualifying equipment, validating processes: we manage the lifecycle end to end in line with EU-GMP Annex 15 and risk-based to ICH Q9. With documentation that holds up in an audit.
URS, DQ, IQ, OQ and PQ as a continuous lifecycle for equipment, systems and utilities. Requalification keeps the qualified state evidenced throughout the operating life.
Testing scope and depth follow the risk to product and patient, not a template. This focuses effort where it carries evidential weight.
Integrated Commissioning & Qualification to ASTM E2500: we incorporate supplier testing where justified instead of repeating it on site.
Every requirement remains traceable from the URS to the PQ. That way, documentation carries evidence instead of counting pages.
We validate computerized systems to GAMP 5 (Second Edition): risk-based, with a sense of proportion and without paper that protects no one. The result: systems that are auditable at any time, and data integrity to ALCOA+.
CSV to GAMP 5 (Second Edition): category-based, risk-proportionate and driven by Critical Thinking instead of template reflexes.
We assess supplier documentation and testing and rely on them where they are robust. Our own testing effort concentrates on the residual risk.
Data flows, audit trails and access concepts: we find the points where data integrity fails and close them verifiably.
We implement the requirements of Annex 11 and 21 CFR Part 11 in the system and in operations: from access control to audit trail review.
Quality is created in operations, not on paper. We work within your QMS, close gaps and make you inspection-ready before the auditor arrives.
We work within your quality management system: SOPs, specifications and reports that work in daily practice, not just sit in a binder.
We prepare you for customer audits and regulatory inspections: with gap analyses, for example against Annex 1 and Annex 11, and a prioritized action plan.
Assessing deviations properly, closing actions effectively, managing changes under control: this keeps the qualified state evidenced at all times.
We bring digital tools and AI into GxP operations in a way that keeps them validatable, with an eye on Annex 22, which is currently available as a draft.
Leading projects, aligning stakeholders, improving operations: we take responsibility for schedule, cost and compliance, and deliver in the engagement model that fits your project.
We lead GxP projects across all project phases: with clear responsibilities, robust decision inputs and an alignment that brings operations, QA and suppliers to the same table.
We introduce changes during ongoing operations in a controlled way and embed them for the long term: leaner workflows, less friction, measurably more stable processes.
Fixed price for clearly defined packages, Time & Material for scalable support or reinforcement directly in your team: you choose the model, we deliver the result.
From a clearly defined package to reinforcement in your team: you choose the engagement model that fits the project situation and budget.
Clearly defined scope, fixed price, defined deliverables: full predictability for budget and schedule.
Billing based on effort, transparent each month: scalable when scope and priorities shift.
Our engineers work directly within your organization: capacity and GxP expertise exactly where it is missing.
Five stages, one line of evidence: every requirement from the URS remains traceable through to the PQ.
The URS defines what the equipment, system or utility must deliver: quality-relevant requirements are built in here, not tested in after the fact. It remains the point of reference across the entire lifecycle.
The DQ provides documented evidence that the proposed design is GMP-compliant and fit for purpose. It is verified against the URS before anything is procured or built.
The IQ confirms that the installation matches the approved design: components, piping and instrumentation verified, calibrations recorded, materials and supplier documentation checked.
The OQ demonstrates that the equipment operates as specified across the intended operating ranges, including at the upper and lower operating limits (worst case). Only on this basis are SOPs and training finalized.
The PQ demonstrates that the equipment performs effectively and reproducibly under real operating conditions, tested with production materials or a qualified substitute. Where justified, it is combined with the OQ.
GMP, GAMP 5, Annex 11 and 15 as well as ALCOA+ are our daily business at the equipment. The remaining frameworks form the environment our customers operate in: we know it and are honest about where our focus lies.
EU GMP Annex 22 on artificial intelligence is currently a draft and is treated accordingly.
Qualification gap before the inspection? Talk to us
CSV backlog before go-live? We step in at short notice
Change planned during ongoing operations? Contact us early
This depends on our current workload and is part of the honest assessment in the initial consultation. If we commit, we name a concrete start date that we stand by.
Beides. Wir erstellen URS, Pläne, Protokolle und Berichte selbst oder überarbeiten bestehende Dokumente so, dass sie im Audit tragen.
Standardmässig arbeiten wir in Ihrem QMS und nach Ihren SOPs. Wo Vorlagen fehlen, bringen wir praxiserprobte Strukturen mit und passen sie an Ihr System an.
Ja, das ist unser Regelfall. Wir planen Qualifizierungsschritte so, dass Produktion und Reinraumbetrieb weiterlaufen, in Abstimmung mit Produktion, QA und Technik.
We deliberately take on only mandates we can lead with direct responsibility. You work with the engineers who do the work, not with an account team. We state where our limit lies in the initial consultation, not after the contract is signed.
Unser Standort ist Visp im Wallis. Wir arbeiten vor Ort bei Kunden in der Schweiz und in Deutschland, auch im Rahmen längerer Einsätze direkt im Betrieb.
30 minutes, no obligation. Reply within one business day, directly from engineering.
GxP engineering and validation for life sciences: qualification to Annex 15, CSV to GAMP 5, data integrity to ALCOA+. From Visp in Valais, for Switzerland and Germany.
Vispact GmbH · Mondstrasse 6b · 3930 Visp · Switzerland · UID CHE-160.105.904
info@vispact.swissVier Situationen, in denen Vispact übernimmt, bevor sie zum Befund werden.
Audit-Finding zur Datenintegrität, die CAPA-Frist läuft.
Neues MES oder LIMS vor dem Go-live, die Validierung nach GAMP 5 fehlt noch.
Inspektion angekündigt, der Qualifizierungsstand hat Lücken.
Anlagenerweiterung im laufenden Betrieb, URS und Qualifizierungsplan fehlen.
