Quality and Productivity in Pharmaceutical – Today, it seems like everyone is talking about digitalization – for a good reason. Appropriately done, digitalization can unlock a whole host of benefits for companies, including greater efficiency, cost savings, and the ability to do data analysis.
But to harness these rewards, digitalization must be carried out intelligently – especially in the pharmaceutical industry, where compliance and patient safety are the key drivers.
Getting medicine to market means guiding a maze of clinical trials and federal rules. The Pharmaceutical Industry is home to some of the multiple far-reaching provisions for market research within a current business. From specific vantage points, the drive seems slow-moving; drug development can carry several years (if not decades), with the duration between NME declaration and found averaging 10-12 years.
In a recent roundtable meeting, the Director of Market Research asked: “What does it mean to establish a new development in a digital domain, and how can we sufficiently support those actions from insights stand?” He pointed out that the usual stakeholders—patients, physicians, and healthcare plans—to whom research teams traditionally turned for insight are now less readily available.
These realities make knowledge management even more crucial for pharmaceutical market research teams. And, of course, this industry faces new challenges with the onset of the COVID-19 pandemic.
One area ripe for digitalization is calibration. Calibration is still largely paper-based in the Drug pharma Manufacture industry, so there is room for human error across the many steps required.
Process instrument calibration is just one of the multiple maintenance-related actions in a manufacturing factory. It doesn’t make sense for visitors to use their limited resources and time to complete unnecessary calibrations or follow time-consuming, inefficient calibration methods.
Using paper for calibration also means that a vast potential resource – data from calibrations – is being wasted as it’s sitting in binders in a storage room rather than being quickly available for analysis.
Successful management of these senses and information needs a platform that combines effortless collaboration with sophisticated categorization and compliance procedures. The Insights function must ensure that all study activities and market-related positioning are performed without causing damage to respondents and paper compliance with regulatory provisions for auditing and reporting.
How automated calibration works
An integrated calibration solution is an intelligent way to digitize calibrations.
Such a solution integrates the actual calibrators, centralized calibration software, and enterprise knowledge to produce an automated and paperless flow of calibration data.
This means shifting away from resource-intensive manual data access towards an automatic system where everything is validated automatically by an unmarried technician using a multifunctional machine – in real-time and with no space for human mistakes.
The benefits of digitizing and automating calibration are numerous and include the following:
- Ensuring patient security and compliance by providing that instruments are working within tolerances
- Each calibration takes a shorter time, enhancing operational efficiency
- Smart calibrators can guide technicians to decrease errors during calibrations
- Management can make better-informed conclusions based on current data
- The virtue of calibration data is kept safe in a tamper-proof central repository
- Data can be seen quickly and efficiently for audit purposes
How to ensure successful digitalization
Several things are needed to ensure digitalization serves a helpful purpose and fulfills its potential.
Firstly, the proper expertise ensures that systems comply with the Food and Drug Administration’s Good Manufacturing Practice (GMP) and other regulatory requirements. The GMP requirement 21 CFR Part 11, which regulates how the calibration certificate is documented and signed electronically, must be followed to create a compliant process.
Secondly, the actual calibration solution software and hardware need to be designed to minimize or remove the need for human input. This reduces the chance of error and eliminates the need for the “four eyes” principle – where the second set of eyes is needed to confirm calibration data is recorded correctly.
Finally, software tools must be available to quickly access data, for example, for audit purposes and to carry out a trend or other analyses on calibration data. This data can also predict when a device drifts out of tolerance to optimize maintenance or compare performance between factories to maximize efficiency.