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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.

James Francum
By James Francum
on September 03, 2014

ICH Harmonization ProcessThe methodologies your firm employs in the creation of pharmaceuticals, medicines and similar products designed for human consumption are most likely unique. Even if you follow relatively common chemical or physical manufacturing procedures, for instance, you still have to make modifications that fit your specific product design standards.