Editor’s choice 6 ADD MAChINE LEARNING
Making this detailed information available to people has tremendous value, but it still requires them to actually spend time looking at it. Although it cannot do everything, in many cases, you can automate that analysis process so that it is continuously analysed. Some systems have unsupervised machine learning (ML) capabilities: simply provide the data and the system will look for and report anomalies. This style of ML has the significant advantage of simplicity: no expertise required. Other applications warrant investment in process and technology expertise to add supervised ML, commonly as early failure predictions.
7 COMPARE LIkE FOR LIkE
Building on process analytics successes at individual sites, many organisations advance to analysis and comparison across their fleet. The more homogeneous the sites, the more direct the comparisons can be, but few industries actually have “cookie cutter” plants. So, before making these comparisons, there must be some effort to normalise information—whether that is standardising on “m3
/day” vs.
“litre/minute” or agreeing on how to calculate Overall Equipment Efficiency (OEE). In global businesses, with multiple operations and multiple sites, being able to do peer to peer comparison – in a standardised manner - is a real value add. Previously, this would have been a task of overwhelming complexity and cost for smaller businesses. Now, with the cloud, this type of comparison is much more accessible and achievable.
eatIng the elephant
Tackling sensor data analytics automation can feel overwhelming, but there is no need to eat the elephant in one sitting. It is quite possible to take single, exploratory steps on this journey as the need arises and the budget is available. You might stop for a while, having implemented one step, and see how it works out for you. Most of the incremental steps can be self-service and do not need external expertise. The journey to getting value from applying
AI and ML to sensor data starts with a single step. As the benefits start to accrue, cost savings will mount and productivity will rise, demonstrating clear business value from intelligent sensor data analytics. It will become a no-brainer to progress further along the route to optimum data-driven decision making.
AVEVA
www.AVEVA.com Instrumentation Monthly February 2021 case stuDy
its biomarker manuFacturing Fujirebio Diagnostics implements
paperless electronic initiative For
accumulated experience in the conception, development, production and worldwide commercialisation of robust IVD products. Founded in 1950 in Tokyo, Japan, Fujirebio
F
has over the years concluded a number of successful acquisitions of best-in-class IVD companies. Today, Fujirebio’s global presence includes offices in the United States, Latin America, Europe and Asia as well as a vast international distribution network. Fujirebio has a strong and long-lasting tradition of collaborating with experts in the global clinical community in the development of high-quality routine and truly novel biomarkers that cover a variety of disease states. Its IVD product lines span the range from specialised manual and automated testing to fully automated routine clinical laboratory testing solutions. Operating in the life sciences industry
means that Fujirebio must adhere to a strict manufacturing process. These processes are certified with compliance for reporting and documentation requirements that are very detailed and extensive. The biomarkers produced help physicians, lab professionals and patients better manage disease. Due to the volume and precise reporting
requirements, Fujirebio was looking to address three challenges. First, significant time is spent each day manually reviewing reports. Second, the existing paper-based system was time- consuming and vulnerable to reporting errors. Third, the company wanted to find a new system that ensured it remained in compliance with federal regulation.
InnovatIon always starts wIth an Idea
The project started when the personnel at the Malvern, Penn. campus identified a major
ujirebio is a global leader in the field of high-quality In Vitro Diagnostic (IVD) testing. It has more than 50 years’
opportunity to save time and paper, while still retaining compliance by automating the acquisition of equipment data and generating electronic reports for review and approval. The solution is called the Electronic Initiative and the first phase of the implementation is called the Equipment Monitoring System, or EMS. The EMS system at Fujirebio performs a number of very important functions such as:
Enabling personnel to monitor equipment from their workstations
Maintaining all temperature readings in electronic records
Notifying authorised personnel in the event of adverse temperature trends
Generating electronic Good Manufacturing Practice (GMP) reports for review by exception
Providing authorised personnel electronic signature capabilities to approve reports.
results
Fujirebio’s electronic initiative helps produce 75 million tests that are distributed throughout the world. The new solution is completely paperless and provides electronic record collection with electronic signatures while maintaining 21 CFR compliance and ISO 9001 and 13485 certification. The equipment monitoring system saves
about 1,100 hours per year. The tasks related to manually logging equipment parameters and reviewing paper logs and charts is eliminated and has reduced data reviewing time from 15+ hours to just minutes. Electronic monitoring saves 2/3 of time, or
about 10 hours per month in quality assurance.
www.AVEVA.com
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