In GxP projects, schedules rarely fail on the technology. They fail at the interfaces: engineering plans, the quality unit assesses later, the supplier delivers to its own reading, and operations hears last. We lead these projects rather than merely accompany them: one accountable point for schedule, cost and compliance. From Visp in Valais, on site in live GMP operation.
A project only holds when engineering, operations and the quality unit share the same basis for decisions. That interface is what we lead. Our scope:
Every service ends with a document that holds up in an audit, not with a recommendation. What you actually receive:
We settle at the start what many projects only settle in dispute: who decides what, against which criterion, and who carries the outcome. That includes the work breakdown structure, roles and deputies, the escalation path and a reporting format operations and the quality unit will actually read.
Deliverable: an approved project manual with a role matrix, decision paths and reporting cadence.
The schedule reflects what qualification genuinely requires, not just erection. Quality-relevant activities sit in the plan with their dependencies, so testing does not slide to the end. Costs are tracked against the approved scope.
Deliverable: a schedule whose critical path includes qualification activities, plus cost tracking against the baseline scope.
Most delays arise between the parties, not within them. Requirements are written once and countersigned by all sides, supplier documents are assessed against the user requirements, and the quality unit is involved before a decision is taken.
Deliverable: a maintained interface register with named owners and documented agreements.
Changes to qualified equipment run through the operator's change control procedure. We prepare the request on the technical merits, assess the impact on the qualified state and derive the requalification scope from it. The quality unit grants approval.
Deliverable: a justified change request with impact assessment and a derived requalification scope.
We write requirements so they can be tested, assess bids on substance rather than price alone, and attend the acceptance tests. What was verified at the works is documented so it remains usable on site, instead of being tested twice.
Deliverable: a testable specification, a technical bid comparison and a supervised factory acceptance test.
A project is finished when operations can work with it, not when the plant runs. We hand over with complete documentation, trained staff, an open-items list with owners, and a requalification strategy that is sustainable in daily operation.
Deliverable: a handover pack with documentation, open items, responsibilities and a requalification strategy.
Capture the starting position, objectives, constraints and the critical points in the schedule, together with operations and the quality unit.
Define and have approved the work breakdown structure, roles, decision paths and reporting format.
Write testable requirements, build the schedule around qualification activities, assess suppliers on substance.
Lead the interfaces, surface deviations early, run changes through the operator's change control procedure.
Close out the documentation, hand over open items with their owners, embed the requalification strategy.
We do not administer the schedule, we lead the project. Decisions are prepared and taken, rather than deferred to the next status report.
Our project managers are engineers. Supplier claims and schedule risks are assessed on the technical merits, not by the colour of a status field.
Testing sits in the plan with its dependencies, not as a remainder at the end. That is the most common reason GxP projects run late.
We prepare decisions on the technical merits and justify them so they hold up in an audit. Criticality and approval rest with your quality unit, independently.
The burden of proof. It is not enough for the plant to start on time; it must be documented that it is installed as intended, functions correctly and meets the defined requirements. That changes the planning: qualification activities belong in the schedule with their dependencies, changes run through the operator's change control procedure, and the quality unit decides on criticality and approval independently.
Either is possible. We take on the project management with responsibility for schedule, cost and technical leadership, or we reinforce an existing project management where capacity or GxP expertise is missing. Decision authority and approvals remain with you in every case, in particular everything that concerns the quality unit.
Through your operation's change control procedure, not alongside it. We prepare the request on the technical merits, assess the impact on the qualified state and derive the requalification scope. EU-GMP Annex 15 requires that changes to qualified equipment are assessed and that the extent of any requalification is justified. Your quality unit grants approval.
From basic evaluation through to detailed design, in the logic of planning phases 1 to 5, extended by support for tendering, commissioning, qualification and handover. We also join mid-project; the work then starts with a baseline assessment, so it is clear what is being taken over and what remains open.
With a 30-minute introductory call, no obligation. We then capture the starting position, the objectives and the critical points in the schedule. From that comes a proposal with scope, engagement model and role boundaries that your organisation can support. Reply within one working day, straight from engineering.
In the introductory call we place your starting position: 30 minutes, no obligation. Reply within one working day, straight from engineering.
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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.swiss