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Dr. Elham Abdollahi-Mirzanagh
By Dr. Elham Abdollahi-Mirzanagh on September 15, 2022

Reliable data is the foundation of your entire product offering but ensuring its reliability is not always easy. Many life science companies rely upon the ALCOA+ framework to ensure data integrity. It is the gold standard set by different regulators all over the world for maintaining compliance with data integrity regulations such as U.S. FDA 21 CFR Part 11.

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 Henry Macartney
on June 23, 2020

Are you sure your IT infrastructures are fully qualified, or is it possible that your methodologies missed some vital detail along the way? Perhaps you know you're good at maintaining infrastructure compliance, but your organization is about to reach its operational limits. Either way, it's time for a serious change.