Latest Insights

Cybersecurity

Operational Technology and Cyber Security must walk hand in hand

Learn more on the key role of Cybersecurity for companies that are potential target of cyberattacks of different nature against their IT & OT.

GxP Compliance

Impact of possible removal of the Titanium dioxide from human medicines formulations was discussed during the CMDh meeting held on 14-17 September

The insight discuss the updated safety assessment of the food additive titanium dioxide (E 171) and experts concerns.

Cybersecurity

5 questions (plus, a bonus one) you should be able to answer to ensure the security of your systems

Find out from PQE experts cyberthreats may affect your Operation Technology and what Practices to perform to put OT at safe.

CSV & Data Integrity

A comparison between CSV Guideline / regulations in Japan, India and China

Find out the differences between CSV guidelines and regulations in Japan, India and China.

Medical Device

EU IVDR – Clinical Evidence and Performance Evaluation

The new Regulation 2017/746 for In Vitro Diagnostic medical devices has been published and the new requirements for Clinical Evidence are some of.

GxP Compliance

Covid Vaccine Technology Transfer: 5 reasons, risks, good practices

Find out from PQE experts how to perform a strong technology transfer to boost your vaccines production and meet compliance standards.

Pharmacovigilance

Pharmacovigilance Data: challenges for Pharmaceutical Companies

Data format, data location and data migration are recurring topics for Pharmacovigilance departments nowadays, learn more about the challenges to.

IT Operations

Smart Working: dealing with IT support implications

Discover the features and priorities that IT activities should focus on, considering all the new problems coming from remote accesses.

GxP Compliance

Covid-19 & Pharmaceutical manufacturing: the challenges for production quality, safety and continuity

Covid-19 impacts the daily routine of Pharma manufacturers, raising new challenges for employees’ safety and products’ quality.

Annex 1

2020 Annex 1 draft: new challenges for sterile manufacturers

The new Annex 1 is a milestone standard for all sterile manufacturers, with important insights and implementations for the sterility assurance of the.