<iframe src="https://www.googletagmanager.com/ns.html?id=GTM-NWS6QFW" height="0" width="0" style="display:none;visibility:hidden">

Automation for Continuous Compliance in BioPharma and Life Sciences

Posted by Jim Damato

Over the past year, the emergence of COVID-19 has pushed the BioPharma industry to deliver faster than ever before, yet it can be hard for any industry to keep up with such demand.

Read More »

Viral Controls and Prevention of Cross-Contamination in the Vaccine Industry

Posted by Sandra Acosta

This post is the second in my series covering the pressing concern of cross-contamination in the vaccine industry. For background on the subject, visit my original post, “Sources of Cross-Contamination in Vaccine Production.” 

Read More »

Celebrating Eliassen Group’s Brand Evolution and Expanded Service Offerings

Posted by EG Life Sciences

EG Life Sciences, a company of Eliassen Group, is proud to share big news within our extended family. Recently, Eliassen Group unveiled an updated brand to reflect their expanding service offerings, reinforce their company values, and more directly communicate the value they provide their clients.

Read More »

Sources of Cross-Contamination in Vaccine Production

Posted by Sandra Acosta

As more vaccines for COVID-19 emerge, safety in the vaccine production process is crucial. Any foreign matter entering the vaccine production process raises major safety concerns, and contamination is a common occurrence and a public health risk. 

All of us who work in the Biotech industry, including those of us at EG Life Sciences, face daily challenges to maintain an aseptic environment. Rigorous safety standards are in place to avoid any cross-contamination and/or any foreign matter being introduced to the vaccine production process. However, there is still a chance that this could happen. 

Read More »

What if Continuous Compliance were possible in the Drug Industry?

Posted by Jennifer Mariani

The biggest question on the minds of leadership at pharmaceutical companies is 'how do we respond more quickly to this rapidly changing market?'  Regulatory requirements are changing constantly,  companies need to keep up with the digitization prominent across the industry, and there's mounting pressure for drugs to be delivered more quickly.  Now that the Covid-19 vaccine has been delivered to market in 9 months, others are interested in how that is possible. 

Read More »

EU IVDR Requirements for Certification

Posted by EG Life Sciences

Is your company as far along as it needs to be?

The In Vitro Diagnostics Regulation, or the IVDR, was created to ensure a greater level of patient protection and regulation around the creation of in vitro diagnostic devices (or IVDs). The IVDR will replace the legacy In Vitro Diagnostic Directive (IVDD) and should ensure a greater level of patient protection and provide rules and regulations that are more effectively implemented.

The manufacturers of these devices are well aware of the IVDR that will soon take effect. Most of these manufacturers are already taking the necessary steps to prepare to comply with this new regulation, but are they as far along in their preparations as they should be?

Read More »

Is Agile the Answer to Big Pharma's Digital Revolution?

Posted by Jennifer Mariani

In an age when your daily wants and needs can be delivered by Amazon, we are a culture of instant gratification. This culture has bled into all walks of life, including our medicine. In June of 2018, Amazon bought PillPack out of Cambridge, MA, for $753 million to crack into the $500 billion dollar prescription market. With this acquisition, customers can get meds delivered to their door with automatic refills and 24/7 customer support.

Read More »

How to Handle Out of Specification (OOS) Results

Posted by EG Life Sciences

Your cold room just went down. Now what?

Read More »

Net Promoter Scores: What Do the Numbers Really Mean?

Posted by EG Life Sciences
What are Net Promoter Scores?

Have you heard of Net Promoter Scores? A company’s NPS or Net Promoter Score is a measurement of customer satisfaction.1 These scores are especially useful in the staffing industry, in which feedback isn’t linked to a tangible product, but is instead related to a more subjective service or experience. For example, when a client says their experience with us was “good,” it’s difficult to derive true meaning from that response, especially as the definition of “good” likely varies vastly from client to client. Thus, the staffing industry was in need of a universally understood, tangible measure of a subjective experience. Enter NPS. While NPS surveys can ask a number of questions, the concept truly focuses on only one:

How likely are you to recommend your firm to a friend of colleague?2
Read More »

FDA Form 483 vs. Warning Letters: What's the Difference?

Posted by EG Life Sciences

When the FDA inspects a pharmaceutical or biotechnology company’s manufacturing facilities, they can either alert the company ahead of time or show up unannounced. After the inspection is over, the FDA might send what is called an FDA Form 483 or a warning letter. There are differences between each and varying consequences depending on how each of these is handled.

Read More »

Subscribe to our Blog

Popular Posts

Popular Posts