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James Francum
By James Francum
on July 21, 2021

Regulatory bodies like the FDA enact initiatives on a routine basis. While their timing may seem random, such actions are usually driven by logic; most are taken in response to some noteworthy concern.

Gabriel Sena
By Gabriel Sena
on June 30, 2021

The world is getting connected more than ever. 

We know that  COVID  pushed the digital transformation and the cloud solutions, in combination with the broad access of the Internet, turning data consumption economically capable and available, creating an exceptional volume of data nowadays. 

James Francum
By James Francum
on June 11, 2021

The Quality Systems (QS) Regulations of FDA 21 CFR 820 are general standards that apply to finished devices, that are intended for human use. Rather than impose strict requirements, the regulations offer an opportunity to the manufacturers of these devices to incorporate their quality management standards into key organizational processes.

By Julian Oberle
on June 02, 2021

Let’s start this piece with a question for ourselves: do we still need password expiration as a security measure? In today’s life science industry, especially the pharmaceutical sector, a number of compliance reasons, guidelines, and agency regulations are responsible for an organization’s requirement to have their employees change their passwords every so often. It is now fair to say that we arrived at a point in time where most of the reasons behind the password expiration policy seem obsolete. 

James Francum
By James Francum
on May 19, 2021

According to a report from the US Food and Drug Administration (FDA), major deficiency letters were issued to 67% of premarket approval applications. Such deficiencies in applications can hold up premarket approvals - sometimes more than 180 days.