Case Study

Optics Healthcare Manufacturer Upgrades Critical Automation in Record Time to Meet Regulatory Compliance


A healthcare producer focusing on optics had systems critical to their manufacturing process that desperately needed replacement. The client had an obsolete environmental monitoring system (EMS) and purified water controls consisting of:

  • Old and no longer supportable technology/servers
  • PLC Hardware was old and obsolete with I/O modules no longer available from the OEM
  • System itself was constrained:
  • Had to dive into code to make changes
  • Not very user friendly for set-point changes
  • All reporting was completely manual

Malisko was requested to provide the client a more modern and validated system that was:

  • Contemporary hardware fully supportable for years to come
  • Robust networking
  • Operator friendly
  • More built-in compliant audit trailing
  • More intuitive troubleshooting
  • More automatic reporting
  • Meeting all regulatory compliance for Computer System Validation (CSV)


  • Very aggressive project schedule – both pre-installation and on-site work.
  • Client’s shutdown window was 3 weeks – all work had to be completed including CSV within the window or client would fail to meet contractual obligations for product delivery:
  • Remove all hardware and panels (6 I/O panels) then install and operationally check out new ones
  • I/O checkout + Validation (aggressive scheduling) including IQ, OQ and PQ
  • Client was foretold by other Integrators “ could never be done in 3 weeks…”
  • Prior to getting involved, other integrators at the plant told upper management that this would be a “multiple shutdown event”
  • “No way you can get it done in one shutdown”
  • Client was not sure existing documents were up-to-date and accurate; therefore, wiring schematics needed to be verified prior to designing the new system.
  • The client wanted an I/O network design based on relatively new technology (bleeding edge) thus raising the risk factor of not meeting the time constraints for system cut-over due to potential unknowns unless Malisko executed relentless vetting and testing of the network design prior to deployment:
  • Parallel redundancy protocol on the I/O part of the network, such as the remote racks.
Services rendered:

  • Controls – New PLC controllers and I/O hardware – Specify, document, configure, program and test
  • HMI SCADA – Specify, document, configure, program and test
  • Network – Specify, document and configure
  • Project management
  • Procurement
  • Contract oversight
  • Validation –
  • Generated all documentation from Validation Master Plan through Qualification Protocols to Validation Summary Reports
  • Participated in executing the validation protocols
  • New server – virtualized server architecture
  • New plant-wide manufacturing network infrastructure
  • Cables, switches, etc – both physical and logical
  • Software – FactoryTalk ViewSE
  • Redundant ThinClient technology
  • Historian upgrade
  • Added to earlier upgrade with this project
  • Automated reporting upgrades


  • Able to rip and replace along with fully validate and turn over to the plant the new compliant systems within the 3 week window – client was able to meet contractual obligations.
  • Provided system that’s easier for operators to navigate, oversee and manage the processes:
  • Two large ThinClient screens in control room
  • Each ThinClient view screen split into 4 quadrants
  • EMS system displayed on the top screens and Purified Water system on bottom
  • Alarms displayed in a single pane of glass
  • More efficient in monitoring the critical production systems after project completion
  • Monitoring rooms’ environmental conditions at a very granular level – greatly reducing the risk of non-spec product being released for shipping
  • Contemporary controls, I/O, network and server hardware supportable for many years to come
  • System is validated and fully compliant with FDA regulations for governing CSV
  • Client has a fully-supportable, robust automation and reporting system meeting regulatory compliance


Malisko and the Client’s project team received tremendous praise from client management after the successful completion of the project for meeting all expectations of being in budget, meeting system requirements and completing all deliverables within the tight time constraints.

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