Articles

GxP Distant Assessment and Remote inspection. The point after one year of application

Two years after the start of the COVID pandemic that disrupted not only our lives, but also our way of working, we have learned to juggle, more or less effectively, a thousand new challenges and opportunities for change.

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Quality Assurance in the Pharmaceutical Sector

Our goal is not the mere transposition of paper documentation to a digital medium, but the redesign of the quality process enabled by digital technology to make it more efficient, faster, visible, accessible and in compliance with the Data Integrity requirements of the pharmaceutical sector.

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Life Science: Once upon a time, there was a paper-based procedure
April 2021

The transformation of procedures from paper to knowledge: this was the theme of the webinar organised by LifeBee last March 3, with the patronage of Assolombarda and the original and innovative contribution of Heike Roeder

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Qualified Person and Digitalization

NCF Notiziario Chimico Farmaceutico - Nr 5, June 2020 - by Mirka Broccato The Covid-19 tsunami has further confirmed to what degree Digitalization plays a central role in enabling remote working in total compliance if conditions should require. The role of the Qualified Person (QP) is to ensure the quality of a medicine, employing the […]

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Digital Therapies: when the Medicine is Software

Teresa Minero for ICF – Rivista dell’Industria Chimica e Farmaceutica – May 2020 The Digital Therapeutics Alliance (DTA) defines Digital Therapies (or DTx) as follows: "They offer scientifically supported, therapeutic interventions to patients, who are then monitored by high-quality software programs to prevent, manage or treat a broad spectrum of behavioural, physical and mental conditions." […]

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Pharma 4.0: a new perspective of opportunities and constraints

Teresa Minero, Founder & CEO LifeBee e Alberto Augeri, Managing Consultant LifeBee, firmano l’articolo “Pharma 4.0: a new perspective of opportunities and constraints” per MEDIC Volume 26 – Dicembre 2018 – Pacini Editore Medicina. Industry 4.0: the concept is not new, yet 4.0 opens a brand-new perspective: everybody is involved, with new technologies. Pharma 4.0 […]

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Digitalization and Covid-19 in the pharmaceutical industry: three testimonials from our customers and some numbers

The Covid-19 health emergency has confirmed that a digital company is also a resilient company, capable of adapting quickly in the wake of unforeseen events and guaranteeing effectiveness and continuity of its core business processes.

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Manufacturing Process Digitization - Manufacturing Execution System (MES) in Pharma

In our DNA is the drive to approach MES management in Pharma with an overview that simultaneously addresses all the compliance, data integrity, efficiency and impact requirements that the final solution will need to meet.

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Document and data digitisation: an essential practice for conducting GxP Distant Assessment and Remote Inspection in Pharma.

On 23 November, during the ISPE 2020 Annual Virtual European Meeting & Expo, a roundtable discussion was held with participants from several major international regulatory authorities on the topic of Distant Assessments During and After COVID-19.

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