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Intelligent Innovations for the QA/QC Labs of the Future

Errors come in all shapes and sizes. While human errors are usually accidental, these mistakes can have far-reaching consequences in the pharmaceutical industry, including risks to patient safety. Even when the damage is minimal, errors cost time – and time costs money.

Lab users often struggle to identify errors, and most current liquid chromatography instruments cannot flag them proactively. Current systems generate huge amounts of metadata that also must be manually checked for errors. This can be a significant burden for two reasons: (1) increasing amounts of time are spent searching for errors, and (2) these mistakes can cause a significant chain reaction before they are detected. Random errors and mistakes that only occur in very specific circumstances are even harder to spot. Many errors will also be detected at the review stage; these reviews require expert attention and time, and cause bottlenecks in many quality control (QC) labs, where speed and consistency are vital.

Is it possible to overcome these obstacles and improve outcomes in the QA/QC environment? A movement toward intelligent instruments and automated processes could make a big difference. But how can augmented intelligence helps us to detect – and even prevent – errors? How will these capabilities (and others) impact daily life in the lab? And what difference could all of this make for patients?

Errors in the Age of COVID-19

Prior to COVID-19, big changes were already happening in labs, with one key example being a shift toward remote working. When the pandemic struck, however, remote work became essential, staff turnover increased, and team presence in the lab (including that of supervisors and senior managers) was vastly reduced. The way labs worked was transformed overnight and adapting to the restrictions was no small feat.

Staff onboarding also became increasingly complex. Under usual pre-COVID circumstances, training a new employee could take months, with complicated elements of the job like diagnosing and troubleshooting problems taking longer still to learn. During the pandemic, new employees (who were likely to be unfamiliar with the existing systems) entered the lab with limited opportunities to receive in-person training. Under these circumstances, it’s highly likely that mistakes will be made, and go unrecognised for an extended period of time.

Common mistakes in the QC lab might include:

• Mislabelling of vials

• Incorrect sample preparation

• Incorrect selection of HPLC columns

• Failure to correctly follow standard operating procedures (SOPs)

• Incorrect loading of HPLC well plates with samples.