As our world becomes increasingly digital, simplicity can be a rarity.
Automated machinery and artificial intelligence are incredible innovations, one that has the ability to stifle complexity. However, they offer little help when it comes to monitoring and documenting quality standards. During Pharma 4.0, the spotlight has been placed squarely on GXP compliance strategies, and the Testo 184 data logger series has played a major role in many organisations' success in adhering to the rules.
Duty to the public
Pharmaceutical companies around the world are under increasing scrutiny as the general public has greater awareness about the wide array of drugs on the market. This has led to an increasing number of high-profile recalls over the past decade. The reason for these recalls varies, though some have made international news due to being kept in temperatures that may alter the efficacy of the drug.
In the past, organisations have faced a major obstacle in gaining insight into transportation storage conditions. This leads to regulatory infractions going unnoticed or even unreported. Fortunately, tools like the Testo 184 H1 are allowing businesses to easily monitor temperature and humidity in any space and get up to 500 days on one battery life. This data is easily collected during the entirety of the trip and the device generates a PDF report for GXP compliance documentation once connected to a computer.
Where's the value?
There is a significant financial and reputational cost that comes with failing to report a regulatory infraction. One company that failed to do so decided to fully automate its production line in response to the penalty. Part of the investment was made in digital data loggers which are able to seamlessly generate reports year-round for compliance purposes. This was crucial in helping the organisation cut down on the time it spent monitoring its process while also reducing the possibilities of errors being made.
Some businesses are taking a step further by taking advantage of the
Internet of Things. They are doing this by monitoring the environmental conditions from the start of production of goods through to delivery. Experts believe that the financial benefits of organisations are a bonus in productivity between $67-150 billion worldwide. This is accomplished through automation and assistance from real-time alert systems like the Testo 184 T3, which sets off an alert when intervention is needed during the distribution of the drug.