Engineering
EPCM + C&Q Model
Managing an engineering project in the pharmaceutical sector means combining technical expertise with a thorough understanding of GMP requirements, while balancing precision, planning, and regulatory compliance.
Adeodata supports companies at every stage of the engineering project by working in synergy with the client’s trusted partners and suppliers. We ensure continuity, reliability, and adherence to required standards, transforming every project into an effective and compliant solution.
Our work methodology follows the EPCM Model, integrated with our expertise in C&Q—Commissioning and Qualification.
Preliminary and design implementation support
✔ Assistance with drafting the URS
✔ GMP Impact Assessment
✔ Preparation and/or optimization of layouts (plant, departments, laboratories, technical areas, warehouses, etc.)
✔ Optimization of material and personnel flows
✔ Preliminary sizing of consumption for new installations
✔ Preparation of utility distribution diagrams
✔ On-site surveys for the preparation, integration, or verification of as-built documentation
✔ Optimization of utility routes (HVAC, piping, electrical conduits)
✔ Optimization of process flow diagrams
✔ Verification of design compliance with applicable requirements (Design Qualification, GMP review)
✔ Conducting or assisting with Risk Assessments
✔ Assistance with HAZOP
✔ Process review
✔ Project Management during the engineering phase
✔ Constructability Plan
Procurement and supplier support
✔ Assistance in creating the Vendor List
✔ Technical coordination during the procurement phase (equipment, contracts, services)
✔ Expediting with critical suppliers
✔ Conducting or assisting with Factory Acceptance Testing (FAT)
✔ Inspections of shipments of critical materials and equipment
Construction site management and supervision
✔ Preparation for construction site activities (areas, routes, logistics, storage)
✔ Coordination with HSE and CSE and participation in construction site meetings
✔ Organization of deliveries and placement of materials and equipment
✔ Technical and financial liaison between the client and contractors
✔ Modifications and updates to technical contract documentation during construction
✔ Monitoring of work progress
✔ Periodic reporting on the status of activities
Site closure and commissioning
✔ Support for managing change orders and out-of-scope work
✔ Compilation of final as-built technical documentation
✔ Preparation of the Commissioning Plan
✔ Definition of the Cleanliness Strategy
✔ Definition of the Validation/Qualification Strategy (VMP or QMP)
✔ Execution or assistance with Pre-Commissioning, Commissioning, Start-up, and SAT activities
✔ Execution or assistance with qualification activities (IQ, OQ, PQ)
✔ Site demobilization and handover of areas to the plant
The engineering team
Adeodata’s engineering team is multidisciplinary and highly integrated, designed to support complex pharmaceutical projects throughout the entire plant lifecycle. The combination of expertise in engineering, process, GMP, and Commissioning & Qualification enables a coordinated approach that integrates design, construction, and commissioning, ensuring quality, regulatory compliance, and adherence to schedules.
Our partnership with OC Engineering enables us to provide clients with a large team of professionals capable of covering all key areas of a Capex project in cleanrooms and classified environments.
Team Composition
✔ Engineering Team Lead
✔ Project Engineer
✔ Project Manager
✔ Process Engineer
✔ C&Q Team
✔ GMP Compliance Team
✔ OC Engineering Team
The engineering team
Adeodata has extensive experience in the design, retrofitting, and implementation support of production facilities and departments in the pharmaceutical and life sciences sectors, working on highly complex industrial sites and healthcare facilities.
Some of the projects we have undertaken
✔ HPAPI, cytotoxic drugs, ADCs, medical devices, cleaning areas…
Design and revamping of highly complex pharmaceutical production departments, including HPAPI, cytotoxic agents, ADC, medical devices, and washing areas.
✔ HVAC
Engineering support during the implementation phase, including site coordination, work supervision, plant start-up, and commissioning of critical systems.
✔ New departments or retrofitting of existing sites
Feasibility studies and engineering design for new departments or the retrofitting of existing sites, even in constrained environments.
✔ Controlled environments, cryobanks, sampling rooms…
Projects in the GMP and advanced life sciences sectors, including controlled environments, cryobanks, sampling rooms, and process equipment.
What sets us apart
GMP integration
We combine engineering and compliance for technical and fully compliant design solutions.
Expertise
Years of Life Science projects allow us to anticipate critical issues and propose effective solutions.
Critical Thinking
We tackle each challenge by evaluating strategic solutions to effectively respond and anticipate customer needs.
Customer focus
We listen to the specific needs of each customer and offer customised solutions, guaranteeing constant support.
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