Project governance and management
including GxP contexts
Structure a project trajectory, coordinate stakeholders, make decisions and risks visible, track actions and prepare sensitive transitions.
Expertise
Bring in expertise where the project needs it.
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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Six areas of expertise
Each area opens a dedicated page. Their content is in preparation.
Automation
Page in preparation
Metrology
Page in preparation
Electrical
Page in preparation
Project management
Page in preparation
Energy
Page in preparation
BIM and CAD
Page in preparation
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Recognise the expertise you need
Start from the project situation without already knowing the exact name of the function required.
Potentially 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
03
Four documented functions
These four functions may contribute separately, together or with overlaps, depending on the project context.
Technical design and integration
Assess the decisions required for a system to operate and connect its electrical, automation, instrumentation, EMS or ICT interfaces.
Computerised systems validation and EMS qualification
Maintain consistency across requirements, risks, functions, traceability, testing and the expected documentation.
Field execution, testing and commissioning
Prepare field activities, coordinate operations, verify installations, diagnose deviations and support start-up.
04
Several phases, one project
Capabilities may enter at different points and change as the project develops. This continuity is material for understanding the offer, not a mandatory journey.
Definition and governance
Clarify objectives, responsibilities, risks, interfaces and expected decisions.
Design and preparation
Analyse, design, review, document and prepare for implementation.
Deployment and testing
Integrate, coordinate, execute or support controls at the factory and on site.
Qualification and validation
Connect requirements, risks, evidence, tests, traceability and documentation.
Start-up and stabilisation
Prepare the transition to operations, support commissioning and address the agreed points.
It describes neither an internal organisation nor a team composition. The actual scope is defined for each assignment.
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Targeted expertise or a complementary team
- advice or a review focused on a defined technical question
- responsibility for a specific part of a project phase
- support connecting several stages or interfaces
- a combination of functions where multidisciplinary coordination is required
Our role, contacts, deliverables, responsibilities and verification activities are clarified for each assignment.
The place of pharmaceutical consultancy
Pharmaceutical consultancy belongs within the expertise offer. It brings relevant capabilities to pharmaceutical, biopharmaceutical or GxP projects, including project management, design, EMS, validation, qualification, commissioning and operational readiness.
It is not a generic compliance promise. The applicable frameworks are determined project by project.
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Available technical material
Our experience covers technologies and environments such as 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.
Connections with the services
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.
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What capability does your project need now?
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