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Life Sciences

LOGISTICS PROJECT – AUTOMATED PRODUCT STOCKROOM


Increased storage capacity, simplified logistics flows, uniform logistics processes, improved traceability, better working conditions, increased safety, and segregation of materials and personnel flows.


The project
Construction of an automated storage building for the site’s finished products (no personnel present in the building). Four high-ceilinged storage rooms, between packaging and shipping, and deployment of a transitic and transstocker network controlled by a job sequencer, interfaced with the site’s stock management software.

  • SI systems affected: RIVA, WES (sequencing system), automations, control centre for transstockers
  • Process system: Transstockers, transitics, transfer line, mechanised bays, monitoring, interlocking, access control
  • Infrastructure: Cold rooms, Refrigerated bays, HVAC, GTC, GTB

Owner: Customer
Budget = € 30 million (50% of which for the Infrastructure part)
Prime contractor: O.T.E.
Transitics & Transstocker supplier: DEMATIC
Job sequencer supplier: COURBON (WES)


Scope of work assigned to Assystem

  • Definition of a Project Quality Assurance plan
  • Definition of the validation approach and methodology (Q/V), and definition of the test strategy for all equipment and data systems within the scope of the project.
  • Management of change processes
  • Execution and coordination of platform testing of data systems and equipment Q/V testing
  • Complete management of projects to change process command-control, preparation/revision of technical documentation, or technical upgrades related to compliance with 21CFR Part 11, for example


Results

  • Certification approach suited to the pharmaceutical and business criticality
  • Data system validation strategy in accordance with CSQ, 21CFR part 11 and GAMP policies
  • Traceability of all changes made on the site and key milestones
  • Rapid assimilation of system by users