Digital compliance solution for a lab—Automated instrument qualification

Today, digital solutions are welcomed by the pharmaceutical industry. They are solving some of the critical problems; for instance, going for a paperless lab or bringing more technical control in the processes which we are following and also simplifying the processes which are followed as part of the compliance environment.

We see a lot of pharma organisations that implement digitalisation processes. So, every lab is now aiming for a digital lab and larger companies would have already implemented that successfully. However, there are some companies which are still implementing, or, are in the stage of implementing or planning to implement digitalisation programmes in their labs. So, more than the term digitalisation, it is the objective which is important. That is why the organisations are opting for digitalisation and making the labs paperless. The ultimate objective is to reduce human involvement and have more technical controls throughout the process. Overall, it helps in increasing the efficiency of the lab and also helps in avoiding the data integrity issues. Many companies are implementing systems like LIMS, ELN, SDMS and other applications.

There are other processes like a routine instrumental qualification to maintain the qualified state of the instrument throughout the lifecycle which might also have an indirect impact on the instrument efficiency or lab operations because we are so much dependent on the instruments to generate the results. So, it is also important to focus on that particular area to automate the processes. There are three biggest reasons following either a paper-based or a manual qualification calibration approach. These are human error, increased turnaround time and testing into compliance. These could be there during routine lab operations as well. Agilent has automated the analytical instrument qualification through a validated software platform called Agilent ACE, where algorithms are embedded and we perform our processing and integration and formulas and algorithms are already embedded there. So, the calculation happens automatically. We have identified those areas which might be prone to errors and consume more time for completing this activity and also bring more automation/electronic documentation to reduce the analytical and human errors.

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