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Since 1992, Assystem started diversifying on the basis of its acquired experience in the Nuclear, Automotive and Aeronautics sectors. Using our knowledge of strictly regulated industries, we wanted to invest in the Pharmaceutical Industry, then the Cosmetics and Fine Chemicals industries, to bring the benefits of our expertise to these areas.
 
Initially, we positioned ourselves in the Regulatory Engineering sector. In 1998, with the experience built up in the Project Management Group, we enlarged the Sector offering by responding more and more to your Process and Procedures Engineering needs.
 
Discover the range of sectors we cover, in terms of commitment, problems addressed, professions, and organisational flexibility.

Competencies:


In the frame of our interventions in the pharmaceutical, cosmetics and fine chemicals sectors, we have developed the following competencies:

Projects
  • Technical Specifications & Creation - Modification (Production - Storage - Verifications - Research – Ancillary installations)
  • Revamping
  • Commissioning (Equipment - Installations - Infra - Utilities)
  • Process optimisation
  • Performance optimisation
  • Transfers
  • Automation & Computerisation
Regulatory
  • Master Plan & Validation Plan
  • Qualification of Equipment & Installation (Risk & Criticality analysis, CQ, QI, QO, QP)
  • Validation (Process, Product, Cleaning)
  • SI validation
  • Regulatory metrology auditing, environmental checks
Training
  • Regulatory training modules
  • Methodology training modules
  • Classroom or workstation training
  • Action training

Expertise and support


Expertise


The Assystem professional departments have gathered wide expertise in all pharmaceutical, cosmetics and fine chemicals sectors. Our expertise is centred on the following areas:

Technical:Through intimate knowledge of the main systems commonly used in the pharmaceuticals sector

Regulatory:Thanks to a regulatory watch and constant analysis of changes

Methodology:Through the definition and sharing of our most advanced know-how, resulting from practical reflection and feedback from our experts in the most varied projects.

Support


The Assystem professional departments ensure technical, regulatory and methodology support for all our personnel. This support is made available to you during service provision to provide a better response to your issues. The Technical Support Centre is staffed by experts and has the following tools available:

  • A Pharmaceutical Engineering centre, which offers transversal technical support for all professions
  • The Rear Base: Documentation service responsible for capitalisation and distribution of sector-specific documentation: standards, regulatory texts, associative guidelines, publications, magazine articles, technical documentation …
  • The Forum: A veritable discussion forum, accessible to all employees via the Assystem Intranet, for technical questions and quick answers from the whole Assystem expert community
  • Internal training: The profession departments offer internal and external specific training for our employees, to ensure that all persons use and share the same know-how in all Assystem service provision, a know-haw that is constantly updated
  • Expert interventions: The Assystem profession experts keep a certain minimum availability in their workload to be able to intervene in all service provision contracts

Our offer

To support your performance, Assystem proposes the following services:

  • Regulatory expertise
  • Transfer
  • Maintenance shutdown
  • Water for pharmaceutical use
  • Operational expertise
  • Cleaning validation
  • Process validation
Our professions





  • Process and Procedures engineering
  • Equipment
  • Utilities
  • Training
  • Data systems
  • Regulatory engineering



Examples of projects

Simulation offer
Logistics project – automated product stockroom
AMO project and SCADA environmental monitoring validation
SAP R/3 validation project on 3 sites in France
NEP reliability optimisation project
Documentary system evaluation project


  

Version française


Reference customers


Alcon
Astra-Zeneca
Aventis Pasteur
Aventis Pharma
Baxter
Becton Dickinson
Biomerieux
Boehringer Ingelheim
Diagnostica Stago
Delpharm
Ethypharm
Federa
Fournier
Galderma
GSK
Janssen Cilag
LFB
Lilly
L’Oreal
Merck
Merial
MSD
Novartis
Novo
Oril
Octapharma
Pfizer
Pharmacia
Pharmacie Centrale Des Hopitaux De Paris
Pierre Fabre
Roche
Sanofi - Synthelabo
Servier
Septodont
Solvay
Stallergene