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Pharmaceutical - Life Science

MES software solutions for the Pharmaceutical and Life Science industry

 

Meet the key challenges of compliance, cost and rapid change

The global Pharmaceutical industry has undergone profound changes in recent years, giving rise to a unique set of challenges:

  • Expiry of patents threatening profitability
  • Reducing time to market for new drugs and innovations
  • Mergers and acquisitions changing corporate structures and business processes
  • Changing regulatory environment – particularly impacting non-tier 1 companies
  • Emergence of new bio-tech, new entrants, and the need for compliance and agility
  • Generic drug manufacturers must also meet the compliance requirements
  • Growing cost pressures on the entire industry creating increased need to drive efficiencies in manufacturing

How can Lighthouse Systems MES help you?

Shopfloor-Online is designed to help all Pharmaceutical companies - whether traditional and generic, contract manufacturing or biotech - with the challenges and regulations of drug manufacture:

  • Shopfloor-Online meets all the compliance requirements in terms of GAMP and 21CRF11
  • The Workflow and EBR module allows you to build MES solutions without customisation
  • Use the Weigh & Dispense module to manage this process including direct control of the weigh scales
  • All traceability requirements are fully met from materials, quality checks, equipment, process parameters, operators, all aspects of the process execution are recorded
  • Set up multi-level electronic signatures for sign off
 
  • Dramatically shorten the production release process – all production records are available electronically at the click of a button
  • Save time by working by exception – operators are alerted to omissions and exceptions
  • Create a library of master recipes for all products and processes
  • Enforce Standard Operating Procedures (SOP) – ensure the process follows in strict adherence to the recipe
  • Validate materials when used –  for example, the material is correct as defined in the BOM and is within its use-by dates
  • Enforce Line Clearance Procedures – for example the equipment has been through the proper cleaning cycle
  • Complete two-way traceability of raw materials and finished goods
  • Gain real-time visibility on operations and processes with visual tools and drill-down reporting
  • Improved efficiency across the board with fewer manual operations, accurate performance data such as OEE, Labour, Waste
  • Support continuous improvement  with the Quality and CAPA modules of the Manufacturing Execution System
  • Lower risks and make considerable savings in the production release process
  • Compliance costs are reduced
  • Improve agility through quick integration of new technologies and processes
  • Your Manufacturing Execution System solution doesn’t have to cost $1+m/plant – Shopfloor-Online has its roots in high-volume, cost sensitive manufacturing like the automotive sector. We know how to deliver cost effective solutions to you
  • Support the IT strategy of your company with an information system seamlessly connecting plant equipment to plant operations, to business management.
  • Lower the risk of implementation – take a step-by-step approach to MES software and incrementally meet business needs with Shopfloor-Online modules.
  • Improve access and ease deployment – Shopfloor-Online is web-based, accessible anywhere on the network.
  • A global solution – Lighthouse Systems’ manufacturing operations management solutions are multi-site, multi-lingual, multi-time-zone.
  • Reduce the complexities of support and training  with one Manufacturing Execution System addressing all operations needs.
  • Cloud based MES Software – move the servers to the corporate data centre or move to the cloud.
  • Lean IT – consolidate manufacturing operations with one scalable platform; remove home-grown applications and reduce the number of interfaces to various systems increasingly difficult to support.