Ensuring Data Integrity in Pharma Companies: Practical Steps to Take Today - Pharmision Barcode India

 

The pharmaceutical industry faces mounting pressure to meet stringent compliance standards by global drug regulators. As a result, the FDA emphasizes the critical role of data integrity in Good Manufacturing Practices. Despite this emphasis, FDA warning letters continue to cite data integrity as a failure, with recent years witnessing an increase in citations after a temporary decrease in 2017-2019.

Although the recent 483s citing data integrity have yet to reach nearly 80%, as witnessed in FY2016, it continues to be a problem that the FDA-governed industry struggles with. Moreover, the deficiencies continue to be the same as they were a decade ago

How can pharma companies ensure data integrity?

To maintain data integrity throughout processes and ensure consistency, organizations can implement fundamental changes that are easy to implement and provide long-lasting benefits. Read more....

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Why Must Pharmaceutical Companies Switch to eLog Management Solutions? - Pharmision Barcode India

 

According to FDA’s 21 CFR Part 11, recording and maintaining equipment usage, cleaning, and other GMP activities with the necessary audit trails is essential. Yet, despite its significance, log documentation today is still primarily a time-consuming, paper-based process that puts life sciences manufacturers at serious compliance risk.

Data entry by hand in paper logbooks is labor-intensive and prone to error. First, employees spend hundreds of hours creating, reviewing, and approving logs. Then, during audits and inspections, they waste more time locating this information, which is often stored in various physical locations.

Drawbacks of paper-based log management

The pharma industry has historically needed to be faster to adopt new technology. As a result, many companies continue to follow paper-based log management. However, here are some challenges with this manual and paper-based approach:

Reduced productivity: Manually recording log activities uses many resources. Equipment usage logs take time to physically (and methodically) record the date, time, product, and lot number of each batch. It takes just as long to register the necessary cleaning data. As a result, productivity is severely impacted by manual log management. Read more....

Source Link:- https://www.pharmision.barcodeindia.com/blogs/why-must-pharmaceutical-companies-switch-to-elog-management-solutions/

Automation & Digital Transformation – In the Pursuit of Excellence - Pharmision Barcode India

 

As guardians of human health and life, research and innovation are the non-negotiables for pharma professionals. More than anything else, pharmaceutical companies who tirelessly keep transitioning from one process to another have realized that they need to elevate collaboration between people, equipment, and tech.

Organizations have realized the importance of knowing when they can and they need to produce various drugs, the need for timely delivery, and the urgency of being present whenever there are patient needs. This is accomplished by maintaining a strong network of distribution to establish their brand value and equity.

What automation will mean then

Old school processes require extensive manual intervention from workers and employees. Automation helps eliminate this need and increase quality levels of the output for continuous manufacturing – that is fast spreading across key players for its ability to produce medicines in an end-to-end manner in a single production line. In other words, automation will help reinvent and reimagine how organizations can manufacture medicines with optimized capabilities and how much they can scale while being in line with all regulatory compliances from start to finish! Read more....

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