As contract manufacturing grows in importance in Life Sciences and the volume and complexity of products also increases, maintaining competitiveness is essential for contract manufacturers. This must be achieved in the context of an increasing demand for quality and traceability and the need to maintain maximum flexibility. The ability to execute changeovers and rapidly introduce new products is critical to the success of Contract Manufacturers and helps margin
While some consider an investment in more flexible equipment with faster changeovers to be the solution, the upfront cost is considerable and delays and deviations will still occur at the remaining steps of the manufacturing process. Significant time may still be required to keep track of production, quality, inventory and maintenance operations, whilst ensuring compliance. As a result, real gains in productivity may not be achieved. For example, 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 / device history record can take up to 16 hours to create
- More than 25% of device history records have QA errors
- Average review times are up to 48 hours per order/job/lot/batch record
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. The savings are considerable.
For contract manufacturers of Generic and Branded pharmaceuticals and Medical Devices, it is essential that MES solutions can deal with specific challenges like multiple client formats for production and quality documentation and review, together with different approval and issue cycles for each customer. There is also variation in client’s record retention policies. With a broad range of industry specific experience behind it, LZ Lifescience’s Shopfloor-OnlineTM Lifescience Edition product has been specifically developed to meet the challenges for contract manufacturers:
- Essential functions like Electronic Batch Records (EBR),Electronic Device History Records (EDHR), Equipment Management, Weigh & Dispense, 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 or device history records can accelerate release times by 50-80%
- Material or Tool Dispensing can provide 100% verification of the correct materials, parts or tools used
- 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 main product batch or device history record e.g. setup, cleaning or changeover records
- 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 and products. They can also be configured to run on any manufacturing line, without custom support or coding
- Full integration with existing systems. Shopfloor-OnlineTM 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-OnlineTM 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-OnlineTM Lifescience Edition enables a Manufacturing team to get started quickly with:
- Simple intuitive screens and drag & drop master batch / device history 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 / device history records or another format you require (e.g. customer specific formats).
- Pre-defined building blocks to get started quickly on setting up your existing product batch / device history 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.