Electronic Device History Records

Electronic device history record software: life science

As technologies become more complex and quality and traceability requirements increase, Medical Device manufacturers must meet the challenge of maintaining their competitiveness while ensuring each job/lot meets requirements.

Manufacturing teams are under pressure to keep track of device history record generation, review and approval cycles, equipment logbook checks, training verification and final work order/job/lot release steps. Relying on manual or hybrid systems can be time consuming when there are:

• frequent product changeovers
• an increasing number of work orders/jobs/lots
• a changing number of employees

Errors can easily occur in manual data entry or data can be omitted in error and Life Science industry estimates put this at 5-15% of data entries. Deviations may be detected too late. This situation is compounded by work order/job/lot release reviews that occur days or even weeks after the data was input and teams are under pressure to find all the data and explain what occurred across different shifts.

How can Electronic Device History Records make a difference? Examples of MES working efficiently.

Although often seen as excessively high tech or complex up to now, Electronic Device History Record software has proven that they can make a difference to Medical Device manufacturing. Medical Device manufacturers have seen:

• Data entry times reduced by 40-80%
• Release times accelerated by 50-80%
• Improved ability to keep track of manufacturing with automatic exception reporting and a real-time view of the entire manufacturing process

At every stage of the manufacturing process, solutions like Shopfloor-Online^TM Lifescience Edition EDHR have demonstrated the differences that EDHR software can make to keeping track of and accelerating manufacturing operations. Cost savings automatically follow, with for example, a 3 hour saving on device history record review and approval giving a saving of 1500 hours or 187.5 days per 500 device history records. Shopfloor-Online^TM Lifescience Edition EDHR can increase productivity at every stage of the manufacturing process:

• • Automatic alerts for exceptions: this has proven to be a key benefit of EDHR systems because it automatically identifies issues. Manual and hybrid systems rely on operators to detect multiple exceptions during the whole process, often a challenge during frequent changeover of products and shift personnel.
    Shopfloor-Online^TM Lifescience Edition EDHR will automatically alert the operator to an exception, using a clear visual popup signal and request a comment. It can also automatically alert key staff by email, with details of the device history exception, time detected and cause indicator, ensuring that any action can be taken immediately and avoiding delays and further costs later in the process.
  • 100% accuracy for in-line equipment checks and calculations: many machine settings require frequent checking. In practice, manufacturing technicians may need to check PLC/SCADA systems periodically manually enter the values in the paper device history record. They may also be required to do in-line calculations such as spoilage, waste and good parts produced.
    Shopfloor-Online^TM Lifescience Edition EDHR will automatically capture values directly from the PLC/SCADA system and enter them in the device history record, saving valuable time and ensuring complete data entry. It will instantly perform any calculations required and enter them, saving time again and ensuring 100% accuracy. It can integrate to existing PLC/SCADA, OPC Server and a wide range of other control systems.
  • Keep track in real-time: in practice, this is one of the EDHR benefits that Operations value most and cannot imagine working without.
    Shopfloor-Online^TM Lifescience Edition EDHR gives users real time access to Manufacturing without having to chase down the device history record folders or wait for a phone call. Production and Quality can receive instant automatic notifications when an exception has been generated and immediately determine if the cause/comment is sufficient or if an investigation or deviation is required. Quickly knowing what inventory exceptions relate to also helps to quarantine impacted items.
    It provides Dashboards for KPIs so you can instantly see and report with the latest data for all work orders/jobs/lots so the daily production meeting status and metrics are already there. Reviewers and approvers of the master device history record (MDHR) can receive instant notifications of master device history record approval actions that are required along with a summary of what has changed since the last version was approved. Real-time calls to action save time.
  • Faster equipment set-up: where operators need to set-up equipment, a paper based system means they must refer to a copy of an external standard operating procedure (SOP), work instruction (WI), CAD drawing or graphic. Errors can occur if paperwork is missing or new versions are not at the line.
    Shopfloor-Online^TM Lifescience Edition EDHR automatically displays the approved versions of all documents and drawings needed for each piece of equipment. They can be displayed on a web page or as a hyperlink for users to refer to if they need to. It automatically logs which user has completed the setup and provides electronic signatures to speed up sign-off.
  • Faster Calibration checks: the operator manually accesses the maintenance system or excel spreadsheet, followed at device history record review by Quality who also manually access the system. With an electronic device history record system, easily interfaced to the maintenance management system, the calibration status can be checked automatically in seconds. It can also be checked earlier in the process to avoid further delays. Quality also benefit from this automatic check because the automatic check is validated and does not need to be re-checked by Quality. Notifications can be issued to a maintenance group as a call to action by Shopfloor-Online^TM Lifescience Edition EDHR.
  • Accelerate inputs of Inspection Points / LIMS results: many products require AQL based tests before moving to the next manufacturing operation step. With a paper based system, the value must be entered manually on the device history record from either a result on the laboratory information management system (LIMS) or test equipment or received over the phone.
    Shopfloor-Online^TM Lifescience Edition EDHR fully integrates to LIMS and similar systems. It will automatically capture LIMS results for device quality check points as soon as they are available and enter them in the device history record, saving time and ensuring accuracy. Quality reviews are also accelerated.
  • Ensure trained operators are working where needed: often left to a checklist as part of a manual work order/job/lot release process, the verification of a user’s training for various manufacturing operations or revisions to them, is manually carried out after manufacturing is completed. This can lead to further work to train specific users on revised procedures or to a deviation where no training was ever carried out, an expensive and frustrating situation for all.
    Shopfloor-Online^TM Lifescience Edition EDHR can automatically verify training status by interfacing to the training record management system. It can alert users to exceptions and if required, request them to do a read and understand real-time. It can be configured to stop users proceeding if they are not trained and generate an email alert.

Shopfloor-Online^TM Lifescience Edition provides all of these capabilities and more to drive productivity gains which add up to large savings. It has been specifically designed to meet the needs of competitive, fast moving and highly regulated industries like the manufacturing of Medical Devices and Diagnostics. It provides:

• Electronic Device History Records (EDHR), Equipment Management, Overall Equipment Effectiveness (OEE) and Electronic Work Instructions (EWI) for Setup/Cleaning/Changeover
• Pre-defined workflow templates and a library structure for building master device history records. This drives down the implementation costs of Electronic Device History 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 or machine, without custom support or coding
• Full integration with existing systems. Shopfloor-Online^TM 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^TM 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.
• Simple intuitive screens and drag & drop master 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 device history records or another format you require.
• Modular licenses, only pay for what you need. Rather than charge customers for all modules, we will only charge for modules that you require.

Shopfloor-Online^TM Lifescience Edition EDHR enables a Manufacturing team to get started quickly with simple intuitive screens and drag & drop configuration. Typical implementation times are 3-6 months.
If you would like to discuss how your business can benefit from Shopfloor-Online^TM Lifescience Edition EDHR, please contact us