One of the most critical challenges pharmaceutical companies face today is ensuring that their business practices, rules, and procedures comply with regulatory requirements. Failure to meet compliance standards can result in legal liability, steep fines, and placing patients in danger. Compliance teams and management ensure that pharmaceutical products are effective, untainted, and safe.
Much like other aspects of the industry, the dramatic impact of compliance by the necessary integration of digital technologies and computers. Compliance documents can be stored electronically, so companies need not maintain and organize paper documents. Moreover, paper documents that are still necessary for regulatory reasons can be digitized and backed up electronically.
Storage and environmental data of storage facilities that house pharmaceutical products can also be stored electronically and reported to regulatory authorities. Furthermore, this ecological data can be collected and recorded electronically, limiting human error and labor costs.
How Data Loggers Improve Pharma Compliance
Data loggers are small electronic devices that measure and record environmental data such as temperature, humidity, and differential pressure. Temperature measurements are vital for the pharmaceutical industry because many pharmaceutical products become unstable or ineffective if exposed to temperatures outside specified ranges.
As a result, when pharmaceutical products ship to patients and healthcare facilities, compliance and supply chain professionals must ensure that they store at proper temperatures at each phase of their journey.
Therefore, this carefully designed, temperature-controlled supply chain is known as cold chain storage. It is a crucial component of pharmaceutical compliance. To maintain cold chain storage, pharmaceutical companies affix data loggers in storage facilities where keeping products.
These data loggers measure and record storage temperatures at regular time intervals. Document this temperature data on the logger’s internal memory. Later, connect the data logger to a computer or hard drive, and transfer the temperature data.
Next, this data is analyzed, formatted, and submitted to regulatory authorities. Considering that medical products can become unstable or ineffective if stored at improper temperatures, it makes sense that regulators require the temperature readings of storage facilities to be submitted for review. In addition, data loggers are increasingly important because companies use different data types to drive decision-making today.
Buying and setting up the most high-quality, reliable data loggers on the market is one of the most critical ways executives can enhance compliance procedures.
Using Temperature Mapping and Cloud Computing to Improve Compliance Procedures
Even though data loggers are highly automated and accurate when collecting temperature data, they are not without faults. For example, temperatures can vary in different areas within the same storage unit. Therefore, a data logger affixed to one side of the team may detect temperatures within safe ranges while products stored on the other side of the unit are overheating.
Factors like ventilation, unit placement, door placement, and unit load can cause temperature differences within storage units. Accordingly, executives should implement a temperature mapping strategy to optimize compliance procedures.
Temperature mapping entails placing several data loggers in different areas of the same storage unit to capture the range of temperatures. These temperatures can create a temperature map that shows managers if any part of the unit is outside of safe temperatures.
According to Dickson Data, if deviations in temperature occur, managers should be alerted as quickly as possible. That’s why real-time temperature monitoring using cloud computing systems can be another vital strategy to improve compliance procedures.
As a result, this allows data monitors to transmit temperature readings in real-time over the internet rather than logging that data internally. Then, store this data in cloud-based systems, and set up automated alerts to notify management immediately if storage temperatures deviate outside acceptable ranges. That reduces the risk of wasted products, lousy patient outcomes, and regulatory infringement, so it comes as no surprise that cloud systems are quickly becoming the new normal in pharma.
Leveraging cloud storage systems present some other advantages as well. Namely, it allows pharmaceutical companies to rent IT infrastructure from third-party cloud providers such as Amazon Web Services, Google Cloud Platform, and Microsoft Cloud instead of owning and upgrading their infrastructure. Cloud computing also makes sharing data with third parties such as regulators and business partners.
That’s because data stored on the cloud exists on the internet, unlike more traditional data management techniques, which store data offline on hard drives or computer systems. In addition, offline data is more challenging to share with third parties since it typically must be uploaded to the internet via a secure network to mitigate cybersecurity risks before transferring.
Executive Training Procedures
Another important strategy for creating the compliance leaders of the future is to introduce an executive training program that keeps managers up-to-date with the latest compliance procedures in the company. Moreover, companies can use innovative technologies to administer this education.
For example, Learning Management Systems (LMS) are now available to store learning materials and even offer courses online. Learning management systems and learning apps can also track learners’ progress through the coursework. As a result, compliance professionals can track how much coursework influential executives and decision-makers have completed.
In addition, use these learning management systems in conjunction with certainty-based assessments. Certainty-based assessments are a form of multiple-choice examinations that ask test-takers to score their certainty of each answer they provide. This form of testing provides data on not only what compliance policies executives are aware of but also how sure they are about essential compliance procedures.
Administer coursework and examinations through learning management systems through various multimedia formats such as video, audio, or slideshows. As a result, this also facilitates effective remote learning for executives, which allows them to stay up-to-date with compliance best practices amidst their busy schedules. Companies can even encourage executives to take continuing education courses about compliance from other institutions such as Universities or medical conferences.
To sum up, there are several steps pharmaceutical companies can take to create the compliance leaders of the future. Integrating data loggers with cold chain storage procedures, learning management systems, and certainty-based assessments are all significant steps to improve pharma compliance.