GMP consulting that happens on the plant and does not end with the report: 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.
Details on qualification and validation to Annex 15
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.
Four situations where Vispact steps in, before they become a finding.
An audit finding on data integrity, the CAPA deadline is running.
A new MES or LIMS before go-live, GAMP 5 validation still missing.
An inspection is announced, the qualification status has gaps.
Plant expansion during running operations, URS and qualification plan missing.
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
Yes, but not an ordinary one: GMP consulting with execution. Analysis and action plan are part of it; what matters is what follows: we execute on site in running GMP operations, from qualification to SOP.
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.
Both. We write the URS, plans, protocols and reports ourselves, or we rework existing documents so that they hold up in an audit.
By default we work in your QMS and follow your SOPs. Where templates are missing, we bring proven structures and adapt them to your system.
Yes, that is our normal case. We plan qualification steps so that production and cleanroom operations continue, in coordination with production, QA and engineering.
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.
Our location is Visp in Valais. We work on site with clients in Switzerland and Germany, including longer assignments directly in operations.
30 minutes, no obligation. Reply within one business day, directly from engineering.
