Project governance and management
including GxP contexts
Structure the project’s progress, coordinate stakeholders, make decisions and risks visible, track actions and prepare sensitive stages.
Expertise
A project does not always require a predefined service. It may call for a particular capability, a responsibility that needs reinforcement or several disciplines able to work across the same interfaces. MAJ Solutions shapes its involvement around the context, project phase and role required.
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Expertise by project need
Expertise is presented by project situation and phase, without assuming prior knowledge of the exact function name.
Relevant expertise
If the project needs to structure stages, risks, decisions and stakeholder coordination
Project governance and management
If the project needs to clarify an architecture, interfaces or electrical, EMS or automation choices
Technical design and integration
If the project needs to connect requirements, risks, functions, tests, traceability and documentation
Computerised systems validation and EMS qualification
If the project needs to prepare testing, coordinate field activities, diagnose issues or support start-up
Field execution, testing and commissioning
Four complementary functions
These four functions may contribute separately, together or with overlaps, depending on the project context.
including GxP contexts
Structure the project’s progress, coordinate stakeholders, make decisions and risks visible, track actions and prepare sensitive stages.
Assess the decisions required for a system to operate and connect its electrical, automation, instrumentation, EMS or ICT interfaces.
Maintain consistency across requirements, risks, functions, traceability, testing and the expected documentation.
Prepare field activities, coordinate operations, verify installations, diagnose deviations and support start-up.
Capabilities may enter at different points and evolve as the project develops. This representation supports understanding, without describing a mandatory journey.
Clarify objectives, responsibilities, risks, interfaces and expected decisions.
Analyse, design, review, document and prepare for implementation.
Integrate, coordinate, execute or support controls at the factory and on site.
Connect requirements, risks, evidence, tests, traceability and documentation.
Prepare the transition to operations, support commissioning and address the agreed points.
This matrix describes neither the internal organisation nor a team composition. The actual scope is defined for each assignment.
Our role, contacts, deliverables, responsibilities and verification activities are clarified for each assignment.
Pharmaceutical consultancy is part of our expertise. It brings capabilities suited to pharmaceutical, biopharmaceutical or GxP projects, including project management, design, EMS, validation, qualification, commissioning and operational readiness.
This expertise is not a general compliance guarantee. The applicable frameworks are determined for each project.
Our experience notably includes SEE Electrical, TIA Portal, WinCC, Mirrhia EMS, Siemens, B&R, Allen-Bradley and Kepware.
These names describe a context of experience. They imply no partnership and no certification.
Design expertise may support engineering and advisory, configurable systems or EMS engineering. Validation and qualification may contribute to an EMS or mapping project where the context requires them. Field execution and commissioning may extend an engineering study or an electrical intervention.
Tell us about the context, current phase, responsibilities to cover and any constraints already identified. An initial discussion will help clarify the expertise required and the interfaces to organise.
Discuss your project