TL;DR

Good Manufacturing Practices (GMP) require detailed documentation and review of production records, a time-consuming and error-prone task. Review by Exception (RBE) automates this process. It highlights elements that don't meet specifications, allowing Quality Assurance teams to focus on what's important. With workflow digitalization, MyCellHub simplifies and streamlines the process, saving time and freeing up staff to focus on more value-added tasks.

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GMP or Good Manufacturing Practices require to carefully document processes and workflows executions. Any production and control record needs to be reviewed so that failures or deviations can be detected before the product is released. These documents can be hundreds of pages long filled with technical data. Reviewing for manufacturing mistakes, illegible entries, missing signatures or other oversights is therefore not an easy task. It is key to prevent the ensuing errors that go hand in hand with repetitive manual tasks which require great attention to detail. Additionally, efficiently passing on these documents for reviews and corrections between operators, Quality Control and Quality Assurance can be both a document control and a logistical challenge.

What is review by exception?

Instead of manually scrutinising each page of the record to be reviewed, a review by exception strategy will automatically highlight all elements of a record that are not within specifications. The quality assurance team only needs to review the highlighted information.

Software Central

Review by exception or RBE is one of the most significant features of digitalisation that will deliver better performance for your GMP operations. What used to be a painstaking quality assessment exercise on paper, can be turned into an agile alert system where staff can focus on analysing and handling issues as and when they arise.

However, digitalisation and thorough integration of data throughout the whole organisation is a key prerequisite for review by exception. Only with digitalised workflows and electronic batch records with interactive work instructions, one can rest assured that all process data is included and nothing has been missed out on. These digital workflows enable seamless integration between manufacturing and QC data that is needed for out of specifications to be signalled as soon as they are detected.

And since prevention is better than cure, right-first-time is key for efficient organisations to prevent corrections eating up time of operators or stalling production. Workflow digitalisation will allow to pro-actively prevent spending time on corrections by checking in real-time for missing information or verifying calculations.

Workflow digitalisation

MyCellHub is a software platform for the digitalisation of laboratory and cleanroom workflows. The platform provides tools for interactive work instructions, automated reports, inventory tracking and equipment management. Not only does it have a built-in audit trail and electronic signatures, but MyCellHub can also integrate data from multiple systems to become your central data management platform for the implementation of a review-by-exception strategy.

If you currently operate with a paper-and-excel-based recording system and trawling through mountains of paperwork is part of your job, opting for the digitalisation of your processes will come as a huge time saver. Free up those expert brains for more value-added work in R&D or data analysis and enable your staff to concentrate on problem-solving or error prevention instead of document reviews.

Do you need to see it to believe it? Book a demo via the button below with one of our specialists and have a look at the software solution that is about to fast-track your operations or discover here how MyCellHub’s Electronic Batch Record helps you to digitalise your workflows.

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