Understand before defining
Consider the use case, site, available information, known constraints and stakeholders before defining the involvement.
About
A technical team designed to connect disciplines.
Built around the interfaces of a project.
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MAJ Solutions was built around a simple observation: in industrial and regulated projects, difficulties often emerge between disciplines. A project decision, technical choice, field constraint or documentation requirement can lose coherence when each is handled separately.
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Three challenges of critical environments
Three challenges recur in critical environments, whatever the site and the size of the project. They are not dealt with separately: it is their combination that makes a project hard.
- regulatory compliance: GMP standards, 21 CFR part 11, validation, with the obligation to prove at any time that installations and records are compliant
- ageing infrastructure: obsolete automation, no centralised supervision, performance that is hard to optimise across a poorly interconnected technical estate
- lack of flexibility: rigid parameter sets, dependence on slow-moving suppliers, field teams without configurable, ergonomic and scalable tools
We bring the relevant disciplines together around a clear scope. Depending on the assignment, that continuity may connect governance, technical design, integration, field execution, testing, commissioning, qualification, validation or start-up preparation.
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What characterises MAJ Solutions
We are a compact, multidisciplinary Belgian technical team. We bring together the responsibilities relevant to a defined context and scope.
- connect project decisions to technical choices and field realities
- clarify interfaces, responsibilities, deliverables and verification activities
- bring in targeted expertise or several complementary functions according to the need
- adapt documentation and controls to the requirements that actually apply
- maintain consistency across preparation, delivery, testing and commissioning where the scope requires it
The disciplines involved depend on the actual need and the agreed scope.
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Working principles
Make the scope clear
Clarify our role, responsibilities, interfaces and the deliverables included in the assignment.
Raise risks and unknowns
Make deviations, dependencies or missing information visible when they may affect a decision, implementation, test or commissioning activity.
Maintain consistency across stages
Prevent engineering, integration, field work, verification and documentation from being treated as isolated subjects when their coordination is part of the need.
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Complementarity organised around four functions
Our involvement is organised around four complementary functions. They may contribute separately or combine where a project involves several interfaces.
Project governance and management
Structure the project’s progress, coordinate stakeholders, make decisions and risks visible, track actions and prepare sensitive stages.
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.
The detail of responsibilities, technologies and frameworks is on the Expertise page.
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Involvement defined by context
We may work on a focused question, a defined phase or a scope that draws on several functions. Points to clarify for each assignment may include:
- the context and expected outcome
- relevant responsibilities and contacts
- available data, equipment or documentation
- interfaces with the client, suppliers and other parties
- planned deliverables, controls, tests or approvals
- handover, commissioning or stabilisation conditions where they form part of the scope
These elements are reviewed as needed, without imposing a set path.
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Base and environments
Based in Belgium, we work mainly in Belgium, Luxembourg and France, and can support projects elsewhere in Europe and internationally, depending on their scope. Our experience in pharmaceutical, biopharmaceutical, healthcare, laboratory, food production and controlled environments is a specialisation of the company, without limiting its activity to the pharmaceutical sector.
Situations and case studies
Case studies illustrate this approach through concrete needs, responsibilities and constraints.
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Does your project require several responsibilities to work together?
Tell us about the context, current phase and interfaces already identified. An initial discussion will help clarify the questions to address and the relevant scope.
Discuss your project