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Life Sciences

AMO PROJECT AND SCADA ENVIRONMENTAL MONITORING VALIDATION


The Project
Selection of a product compliant with 21 CFR Part 11 requirements and providing the same functions as the system currently in production. The product in place was Fix32 v6.15 or 7.0 from Intellution, the types of acquisition performed being temperature, differential pressure, relative pressure, humidity, particle counts and intrusion sensors.
 
The challenge of this deployment was to have compliant systems whilst keeping downtime to a minimum for systems under production, given that these systems ensured the environmental control for all classified and non-classified areas of the two French sites.


Scope of work assigned to Assystem
The provision of support comprised:

  • The identification of existing hardware and software architectures
  • The definition of a product and integration audit plan and the execution of these audits
  • Projetc selection
  • Operating support
  • Preparation of change management documents for existing systems
  • Preparation of validation and certification documents (approval plan, risk analysis, design certification, QI, QO and QP Protocol)
  • Execution of QI and QO tests and preparation of corresponding reports and validation reports

To respond to our customer’s requirements, we proposed the use of test platforms to perform most of the QI and QO phases before switching from the old to the new system.


Results

  • Deployment of a new acquisition system (iFIX 3.0 and iHistorian 2.0 from Intellution, compliant with 21 CFR Part 11)
  • Preparation of validation documents ensuring compliance with 21 CFR Part 11
  • Minimisation of handover time: switch completed in 2 hours




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