News

Do you have a keen eye for detail? Do you always want to know 'why'? Do you enjoy analytical thinking and have interest in computerized systems and technologies? The Auditing Academy may be the perfect opportunity for you!

As well as extending the reach of our comprehensive contract quality management and auditing services for our clients in the pharmaceutical, biotechnology, medical devices, nutrition and healthcare industries and also for regulatory authorities and academia, we intend to consolidate and expand our UK auditor directory with experienced auditors in all the GxPs and CSV, as well as to offer further development training to those auditors building up their portfolios. We believe this will particularly aid our UK, USA and APAC sponsors. Our UK office will be a base for both in-house and contract auditors, similarly to our operations in our Munich HQ (2011) and in Vienna (2021).

Global Health Authorities have introduced guidelines for clinical trials due to COVID-19. GXP Engaged invite you to access our review of approx. 60 of these guidelines covering aspects affected by the pandemic such as the provision of IMP/Supplies to subjects, Subject Visits, Informed Consent, Monitoring & Remote SDV, Sponsor Risk Assessments, Protocol Deviations & Amendments, Safety Reporting etc.

SALSA, Statistical Assessment Layer for Site Audits, is a statistical tool developed to facilitate the selection of study sites, data points and subjects for investigator site audits both remote or on-site.

In early July, The Engaged Database GmbH, with HQ in Munich, Germany, opened a new, independent sister company in Vienna, Austria.

The thoughts of the staff at GXP Engaged are with all those affected by COVID-19, the patients and their families, nurses, doctors and all those on the frontline helping to take care of the sick. We also understand what a difficult time this is for our customers trying to ensure the safety of subjects, preserve the integrity of their studies and working their way through the various guidance documents being issued by regulatory bodies.