Keeping track of manufacturing operations and records: MES software for life science companies & manufacturing batch records

Managing manufacturing operations in a highly regulated industry involves more than managing resources, materials and costs. Manufacturing must be carried out in accordance with strict regulations and records must be available for inspection at all times. Significant time is required to keep track of production, quality, inventory and maintenance operations, whilst ensuring compliance.

Delays and deviations occur for many reasons and can accumulate at all stages of the manufacturing operation, increasing the cost and time of resolving them. Post-manufacturing investigations can be up to 10 times more expensive to execute and resolve “after the fact” than knowing what has gone wrong in a real-time environment.
Relying on paper based and hybrid systems to keep track of operations has important consequences, with Industry estimates for Life Sciences showing that:

  • Incomplete entries or manual transcription errors occur in 1 out of every 10 entries
  • A paper batch record can take up to 16 hours to create and paper device history record can take 8 hours to create
  • Average review times are up to 48 hours per batch in the Pharmaceutical industry and up to 24 hours in the Medical Device industry
  • More than 25% of Medical Device history records have QA errors

However, with Manufacturing Execution System (MES) solutions like Electronic Batch / Device History Records, Weigh & Dispense or Equipment Management, Life Science manufacturers are achieving gains of >25% in productivity, as well as reducing the time and stress associated with managing manufacturing using paper and hybrid systems.

How does ERP fit into managing manufacturing operations?

Although there is overlap between ERP and manufacturing execution systems, in reality both excel in different domains. There are areas of overlap, for example some ERP systems offer Electronic Batch Record modules. However, in reality using ERP to manage manufacturing operations can be counterproductive because:

  • ERP systems excel in supporting functions like ordering, inventory, scheduling, procurement etc and providing a function such as for example, electronic batch records, is often a custom solution per client
  • As ERP systems have grown bigger and more complex to include more functions, making any changes, for example adding a new product to Manufacturing, can require a team of specialists onsite to change the custom coding

Many Life Science manufacturers are implementing a two-layered approach to manage manufacturing operations – an ERP top layer for orders, bill of materials and inventory control and then an interface to a manufacturing execution system (MES) layer which focuses on executing operations on the floor such as electronic batch records or weigh & dispense or equipment management.

MES for Generic and Branded Pharmaceuticals, Medical Devices or Contract Manufacturing

Manufacturing execution systems have proven their value in many industries over the past 10 years, particularly the newer applications developed to deal with fast moving industries. However, for manufacturers of Generic and Branded pharmaceuticals and Medical Devices, there are particular challenges and it is essential that MES solutions are adapted specifically to deal with them. With a broad range of industry experience behind it, LZ Lifescience’ Shopfloor-OnlineLifescience Edition has been specifically developed to meet the challenges for these industries. It focuses on:

  • Essential functions like Electronic Batch Records (EBR), Electronic Device History Records (EDHR), Weigh & Dispense, Equipment Management, Overall Equipment Effectiveness (OEE) and Electronic Work Instructions (EWI) for Setup/Cleaning.
  • These are the core functions that deliver the highest productivity gains for most manufacturing operations. For example:
    • Electronic batch records can accelerate release times by 50-80%
    • Weigh & Dispense functions provide 100% verification of raw material and quantities
    • Equipment Management can ensure compliant equipment usage in line with validated business rules
    • Electronic work instructions can add huge time gains as well as increased compliance for tasks that need to be carried out outside of the batch or device history record e.g. setup and cleaning records. In our experience, applying the 80/20 rule to MES is possible: i.e. 80% of the gains come from 20% of the functions.
  • Providing pre-defined workflow templates and a library structure for building master batch / device records. This drives down the implementation costs of Electronic Batch /Device Records as well as making solutions simpler to support. The library structure with building blocks means that the same blocks can be re-used across many manufacturing lines. They can also be configured to run on any manufacturing line, without custom support or coding
  • Full integration with existing systems. Shopfloor-Online Lifescience Edition has been developed with a universal data interface (UDI) so it can integrate to a full range of control systems, ERP systems, training databases and many other systems. It integrates to ERP systems like SAP, Oracle, JDE, BPCS, QAD & IFS and many more. It can integrate to existing PLC/SCADA, OPC Server and other control system technologies.
  • Web based to avoid heavy IT footprint. Shopfloor-Online Lifescience Edition is a web based application that can be installed in your data center, which may not even be on site. It can be accessed from any existing PC, windows tablet or laptop using Internet Explorer instead of having many dedicated workstations for configuring and executing a system. This eliminates the need to purchase dedicated workstation PCs to access the application.
  • Modular licenses, only pay for what you need. Rather than charge customers for all modules, we will only charge for modules that you require.
  • Rapid Implementation and Manufacturing Gains: with typical implementation times of 3-6 months, Shopfloor-Online Lifescience Edition enables a Manufacturing team to get started quickly with:
    • Simple intuitive screens and drag & drop master batch record configuration. During operation, users work with popup forms that indicate the next steps and that work at the speed of the user. Data collected by the system is presented in easy to read tables and these tables can be configured to closely match your existing batch records or another format you require.
    • Pre-defined building blocks to get started quickly on setting up your existing product batch records, saving hours of work and paper creation.
    • Support for Business Case development and Training. Understanding the time constraints in manufacturing, LZ Lifescience has developed a rapid review process which can automatically calculate business benefits from key data. If you would like us to provide this for your business, please contact us.

If you would like to discuss how your business can benefit from LZL’s solutions or arrange a demo of Shopfloor-OnlineLifescience Edition, please contact us.

“Shopfloor-Online provides us with a world-class measurement system so we can highlight inefficiencies and address them immediately.”

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