Life isn't a game, but sometimes you wish it was. While playing a game, you could always start it over to correct any mistakes or read a guide available on the internet to get a glimpse of what you need to do to win the ultimate prize.
Life would be considerably easier if we got a glimpse of a real-life plot spoiler and knew what to do to save ourselves from getting into an undesired situation. Unfortunately, that's not something happening today in our daily lives.
However, there are some similar benefits we can bring in to the manufacturing .
This is where technology comes into play. EBR is a system developed aiming to improve productivity and compliance for Pharma and Biotech GxP regulated companies through design and a set of tools. We all know that human error is one of the most common mistakes in manufacturing. For BatchLine EBR, there are two features that may sound simple, but they significantly reduce human error as soon as the system is up and running.
Improved guidance is one. Where formally static, document-based information is instead delivered to operators in contextual snippets inside the process using mixed types of media (i.e. graphics, video, and photos, as well as just text) alongside the standard tools and recording methods built into the software they need to do the work. As manufacturing processes are intricately designed and transcribed into Standard Operating Procedures (SOP’s) and Work Instructions (WI’s) this guidance reduces errors and variation stemming from people not having the same understanding and experience of that SOP or WI. As well as the time spent manually handling documents, forms, timers, excels, calculators etc.
Another is Sequence Control, BatchLine will highlight the ongoing instructions to guide the operators to their next step while blocking them from skipping the sequence designed. This feature can also be used to encourage operators to perform specific tasks in parallel in order to speed up the overall process whenever possible. Sequence Control doesn't only guide inexperienced operators who are not sure of what they're supposed to do, it also prevents a veteran who is used to working on through their force of habit ignoring changes made in to improve a process was recently made. This would helps ensure that the manufacturing is done in a standard and compliant a complying manner in the way the company desires.
To further reduce error is the Expected Result feature also helps by automatically providing guided interactions, error checking, and workflow notifications. This provides both information and checks inputs against a controlled specification. The system will clearly state the desired output from each activity together with any acceptable variation range, which can include multiple levels. For example, the expected result of an weighing instruction to capture a temperature reading may have a 1st alert warning at 1% variation, a 2nd at 1.5%, and an Out of Specification limit at 2%. When executed this provides the operator a visual feedback based on these specifications, so firstly they can double check they haven’t made a mistake (which otherwise may have been missed), and then automatically notify relevant quality staff and document information required in the batch record.
In short, these two features allow the operator to understand their course of actions and what they are expected to achieve as ifa little like they're playing a game with a cheat sheet (what could possibly go wrong with that?!).
Vissarut Saksureemongkol, Sales Manager
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Digitising Batch Records is becoming easier for GMP Manufacturers