How do digital workflows enable review by exception?

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.

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What is a batch record?

Since every patient deserves drugs that are safe and efficacious, quality is key for any manufacturer of (bio)pharmaceuticals.

But how do you know that a drug was produced in a way that its quality is up to standards? Strict regulation was put in place, known as Good Manufacturing Practices (GMP), which requires that the production process is thoroughly documented. This is where the batch record comes into play. It is this record that allows manufacturer to answer questions that are critical to product quality, such as; Who did what, and when? Which materials were used? Which procedures were followed and were the results within specifications?

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