PQE Group

PQE Group

Consulenza e servizi aziendali

Reggello, FI 197.975 follower

Chi siamo

WHO WE ARE PQE Group is a women-owned Contract Quality Organisation and Complete Quality Solution provider for GCP, GLP, GMP, GVP & GDP areas in the Life Science Industry. As an international group of over 2000 employees (40% of whom are female), we are composed of 43 nationalities and have experience working in more than 25 languages. PQE Group has an excellent history of supporting companies of all sizes and exceeding compliance standards from our 40 global offices. We are dedicated to creating value for our customers by putting our multidisciplinary teams and knowledge at their service, allowing our clients to achieve and maintain compliance with the latest regulations, and contributing to creating a safer pharmaceutical environment. WHAT WE DO Since 1998, PQE Group has successfully completed more than 15,000 projects worldwide while serving our 1400+ medical device and pharmaceutical clients. We deliver turnkey quality solutions while focusing on offering exceptional cost-effectiveness and maintaining the highest quality of care for our customers. With our extensive experience, effective project management, and exceptional cost-effectiveness, PQE’s solutions are proven to be the winning combination for global corporations of all sizes. WHERE WE’RE GOING We at PQE Group strongly believe that our success is tied to the well-being of the communities and environment around us. We understand that change must come from ourselves first – so we take action through social responsibility goals like sustainable development, gender equality, protection of the environment, and health and safety. PQE Group actively works to achieve our ambitious objectives to foster social change and environmental stability by collaborating with important programs and charity associations around the world.

Sito Web
http://www2.pqegroup.com
Settore
Consulenza e servizi aziendali
Dimensioni dell’azienda
1001 - 5000 dipendenti
Sede principale
Reggello, FI
Tipo
Società privata non quotata
Data di fondazione
1998
Settori di competenza
GAMP, CSV, Validation, Compliance, Qualification, Regulatory Affairs, Engineering, 21 CFR Part 11, Pharmaceutical, Medical Devices, Biotech, Life Sciences, Quality, Audit, SAP, GDPR, Data Integrity, Digital Governance, Cybersecurity, Serialization, IT, IT Infrastructure e Marketing

Località

Dipendenti presso PQE Group

Aggiornamenti

  • Visualizza la pagina dell’organizzazione di PQE Group, immagine

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    𝐑𝐞𝐚𝐝𝐲 𝐭𝐨 𝐚𝐬𝐬𝐞𝐬𝐬 𝐭𝐡𝐞 𝐬𝐭𝐚𝐭𝐞 𝐨𝐟 𝐲𝐨𝐮𝐫 𝐃𝐚𝐭𝐚 𝐈𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 (𝐅𝐫𝐞𝐞)? 🧐 𝐖𝐞'𝐯𝐞 𝐠𝐨𝐭 𝐲𝐨𝐮 𝐜𝐨𝐯𝐞𝐫𝐞𝐝! ✅ ⮱ Maintaining well-managed, accurate, consistent, and reliable data in the life science industry is crucial for ensuring the efficiency and safety of your products. ⮱ 𝐓𝐡𝐚𝐭’𝐬 𝐰𝐡𝐲 𝐰𝐞’𝐯𝐞 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐞𝐝 𝐚 𝐐𝐮𝐢𝐜𝐤 𝐚𝐧𝐝 𝐅𝐫𝐞𝐞 𝐃𝐚𝐭𝐚 𝐈𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭! By taking the assessment, you will be able to identify and evaluate gaps, gain actionable insights, align with regulatory requirements, and streamline your processes. ⮱ 𝐑𝐞𝐚𝐝𝐲?! >>>>> 𝐆𝐨! 🚀 🔗 https://hubs.ly/Q02GKXCK0 #Dataintegrity #DIassessment #LifeSciences #Compliance #DataManagement #PQEGroup

    Data Integrity Self Assessment

    Data Integrity Self Assessment

    focus.pqegroup.com

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    𝐅𝐨𝐥𝐥𝐨𝐰 𝐲𝐨𝐮𝐫 𝐠𝐫𝐞𝐚𝐭𝐞𝐬𝐭 𝐩𝐚𝐬𝐬𝐢𝐨𝐧𝐬! ✨ 👉🏼 Check out the beautiful letter shared by Marco Badiali, MD Compliance Manager, with Luisa Cabria, Global VP of MD Compliance & Regulatory Affairs Senior Equity Partner, 𝐟𝐞𝐚𝐭𝐮𝐫𝐢𝐧𝐠 𝐡𝐢𝐬 𝐮𝐧𝐢𝐪𝐮𝐞 𝐞𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞 𝐯𝐨𝐥𝐮𝐧𝐭𝐞𝐞𝐫𝐢𝐧𝐠 𝐟𝐨𝐫 𝐚𝐧 𝐍𝐆𝐎 𝐢𝐧 𝐈𝐧𝐝𝐨𝐧𝐞𝐬𝐢𝐚!

    Visualizza il profilo di Luisa Cabria, immagine

    Global VP of MD Compliance & Regulatory Affairs Senior Equity Partner at PQE Group

    There is no better time than the present to follow your greatest passions! I received this update from my dear friend and colleague Marco Badiali, who is currently taking a sabbatical year to volunteer across Asia. I wish I could receive messages like this every day—they give me extraordinary PQE Group pride! -- Hi, Luisa, how are you doing? For the last few weeks, before returning to Italy, we have been on Sumatra island and volunteering for an NGO. I was glad to send you this photo since, on the very day of the group photo, I was wearing the PQE T-shirt. Here, in particular, we delved into the great natural disaster that is being consumed by intensive palm oil plantations. The NGO is trying to financially support farmers in converting intensive plantations back to more natural crops such as rubber trees and durian (especially the latter two are critical for orangutan habitat and wildlife in general). On photo day, we were planting trees!!!! The fulfillment that comes from giving back is what drives our company and communities forward. I’m glad to see you making a positive impact and representing our PQE Group team in the best way, Marco!

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    2024: 𝑫𝒂𝒕𝒂 𝑰𝒏𝒕𝒆𝒈𝒓𝒊𝒕𝒚 𝑮𝒂𝒑 𝑨𝒔𝒔𝒆𝒔𝒔𝒎𝒆𝒏𝒕 𝒊𝒔 𝑴𝒂𝒌𝒊𝒏𝒈 𝒂 𝑪𝒐𝒎𝒆𝒃𝒂𝒄𝒌 📈 𝒀𝒆𝒔, 𝒚𝒐𝒖 𝒂𝒓𝒆 𝒓𝒊𝒈𝒉𝒕—𝒊𝒕 𝒏𝒆𝒗𝒆𝒓 𝒘𝒆𝒏𝒕 𝒂𝒘𝒂𝒚 to define it a comeback, but while data integrity (DI) Gap Assessment experienced its 'golden age' before COVID-19, the pandemic shifted many activities to remote work, including computerized systems analysis. While this shift was necessary, the effectiveness often didn't match the impact of direct, on-site evaluations. Fast-forward to 𝟐𝟎𝟐𝟒, and 𝐝𝐚𝐭𝐚 𝐢𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 𝐆𝐚𝐩 𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭 𝐢𝐬 𝐨𝐧𝐜𝐞 𝐚𝐠𝐚𝐢𝐧 𝐛𝐞𝐜𝐨𝐦𝐢𝐧𝐠 𝐜𝐞𝐧𝐭𝐫𝐚𝐥 to helping pharmaceutical companies identify gaps and define remedial actions to ensure drug quality. Read the latest blog by Alessio Petrucci, Principal Consultant, CSV/CSA & Data Integrity Advisor Engineer, Senior Associate Partner, 𝐭𝐨 𝐮𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝 𝐰𝐡𝐲 𝐜𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐬𝐡𝐨𝐮𝐥𝐝 𝐜𝐨𝐧𝐬𝐢𝐝𝐞𝐫 𝐩𝐞𝐫𝐟𝐨𝐫𝐦𝐢𝐧𝐠 𝐚 𝐃𝐚𝐭𝐚 𝐈𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 𝐆𝐚𝐩 𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭 𝐚𝐧𝐝 𝐡𝐨𝐰 𝐭𝐨 𝐝𝐨 𝐢𝐭 𝐦𝐨𝐬𝐭 𝐞𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞𝐥𝐲. Explore further: https://hubs.ly/Q02G9b9G0 #DataIntegrity #Pharmaceuticals #QualityAssurance #CSV #CSA #Compliance #PQEGroup

    The Importance of Gap Assessment on Data Integrity Before an FDA Inspection

    The Importance of Gap Assessment on Data Integrity Before an FDA Inspection

    blog.pqegroup.com

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    🤖 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝘄𝗶𝘁𝗵 𝗜𝗦𝗢/𝗜𝗘𝗖 𝟰𝟮𝟬𝟬𝟭: 𝗘𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝗼𝗻 𝗮𝗻��� 𝗥𝗲𝗰𝗼𝗺𝗺𝗲𝗻𝗱𝗮𝘁𝗶𝗼𝗻𝘀 ↳ In 2023, the ISO/IEC 42001 standard emerged as a significant milestone, addressing the challenges of the rapidly advancing field of artificial intelligence (AI). By emphasizing transparency, accountability, and risk mitigation, the standard establishes a global framework for AI systems. ↳ While everything moves fast and AI seems to encompass us at every step we take, the best thing we can do is to embrace the upcoming changes, and ensure we hold the regulatory knowledge required to comply with the latest standards. ↳ Monica Magnardini's new article comprehensively examines the standard's key requirements, its compatibility with other management system standards, highlights aspects related to the standard annexes, and suggests actionable steps to assure compliance with ISO/IEC 42001. ➡️ Learn more: https://hubs.ly/Q02G9b-10 #PQEGroup #ArtificialIntelligence #ISO42001 #Innovation #ResponsibleAI

    Are You Compliant with ISO/IEC 42001?

    Are You Compliant with ISO/IEC 42001?

    blog.pqegroup.com

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    🚀 PQE Group Launches AI and Data Analytics Division: Innovation in the Service of Life Science We are thrilled to announce the launch of our NEW Regulated Artificial Intelligence & Data Analytics division! This initiative underlines our commitment to technological advancement and regulatory compliance in the Life Science sector, and aims to: ✅ Drive AI-driven decision optimization ✅ Ensure regulatory compliance ✅ Accelerate scientific discovery PQE Group is fully dedicated to leading the way for the continuous advancement of the pharmaceutical and medical device industry! 📄 Access Press Release: https://hubs.ly/Q02Fn3PW0 #AIinLifeScience #DataAnalytics #PQEGroup #Innovation #PharmaInnovation

    PQE Group Launches AI and Data Analytics Division - PQE Group

    PQE Group Launches AI and Data Analytics Division - PQE Group

    https://www2.pqegroup.com

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    𝐓𝐞𝐚𝐦 𝐒𝐩𝐨𝐭𝐥𝐢𝐠𝐡𝐭: 𝐌𝐞𝐞𝐭 (𝐬𝐨𝐦𝐞!) 𝐨𝐟 𝐨𝐮𝐫 𝐆𝐥𝐨𝐛𝐚𝐥 𝐒𝐞𝐫𝐯𝐢���𝐞 𝐋𝐞𝐚𝐝𝐞𝐫𝐬 At PQE Group, we are excited to highlight our various departments and teams and share our appreciation for their work and dedication! ✨ This time, we are pleased to share a lovely photo of our Regulatory Affairs, Pharmacovigilance, and Clinical Operations Global Service Leaders: Guendalina Bruni, Marco Marazzi, and Alessandro Passoni, led by Chief Scientific and Development Officer, Niccolò Sturli, Ph.D ✨ Although this photo doesn’t represent all of our Global Service Leaders (more will follow!), it captures the 𝐞𝐬𝐬𝐞𝐧𝐜𝐞 𝐨𝐟 𝐭𝐡𝐢𝐬 𝐡𝐲𝐛𝐫𝐢𝐝 𝐩𝐨𝐬𝐢𝐭𝐢𝐨𝐧 𝐰𝐡𝐞𝐫𝐞 𝐛𝐮𝐬𝐢𝐧𝐞𝐬𝐬 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 𝐚𝐧𝐝 𝐝𝐞𝐞𝐩 𝐭𝐞𝐜𝐡𝐧𝐢𝐜𝐚𝐥 𝐤𝐧𝐨𝐰𝐥𝐞𝐝𝐠𝐞 𝐜𝐨𝐦𝐞 𝐭𝐨𝐠𝐞𝐭𝐡𝐞𝐫. ✨ Our leaders provide clients, partners, and prospects with tailored solutions through open communication, addressing details, goals, and past and future considerations to ensure continuous support and improvement. ✨𝑪𝒉𝒆𝒄𝒌 𝒐𝒖𝒕 𝒘𝒉𝒂𝒕 𝒕𝒉𝒆𝒚 𝒉𝒂𝒗𝒆 𝒕𝒐 𝒔𝒂𝒚 𝒂𝒃𝒐𝒖𝒕 𝒃𝒆𝒊𝒏𝒈 𝒂 𝒔𝒆𝒓𝒗𝒊𝒄𝒆 𝒍𝒆𝒂𝒅 & 𝒃𝒖𝒔𝒊𝒏𝒆𝒔𝒔 𝒅𝒆𝒗𝒆𝒍𝒐𝒑𝒆𝒓!✨ #PQEGroup #TeamSpotlight #GlobalServiceLeaders #RegulatoryAffairs #Pharmacovigilance #ClinicalOperations #BusinessDevelopment

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    Thank you, Techniconsult Group for sharing! ✨

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    5.382 follower

    Hai dato un'occhiata alla rivista di MakingLife? Insieme a PQE Group, abbiamo scelto #PharmaFuture&Health per raccontare una delle sfide più importanti di oggi: diventare il più sostenibili possibile.   Abbiamo sviluppato dei contenuti mirati che illustrano le soluzioni ingegneristiche sostenibili applicate durante un recente progetto per la realizzazione di un nuovo edificio dedicato alla produzione di medicinali a base biotecnologica.   📖 Approfondisci l'argomento sul seguente Link: https://lnkd.in/dDjCYCBg ----------------------------------- Have you taken a look at the MakingLife magazine? Together with PQE Group, we have chosen Pharma Future & Health to discuss one of today's most important challenges: becoming as sustainable as possible. We have developed targeted content that illustrates the sustainable engineering solutions applied during a recent project for the construction of a new building dedicated to the production of biotech-based medicines. 📖 Learn more about the topic at the following link: https://lnkd.in/dDjCYCBg

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    𝗝𝗼𝗶𝗻 𝗨𝘀 𝗳𝗼𝗿 𝘁𝗵𝗲 PQE Group 𝗨𝗦 𝗥𝗼𝗮𝗱𝘀𝗵𝗼𝘄: 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻𝘀 𝗶𝗻 𝗟𝗶𝗳𝗲 𝗦𝗰𝗶𝗲𝗻𝗰𝗲 ➡️ Deep expert discussions on the latest regulatory trends, AI technology solutions, and sustainability programs are just 𝗼𝗻𝗲 𝗰𝗹𝗶𝗰𝗸 𝗮𝘄𝗮𝘆! ➡️ Check out the agenda and register now for our free live event, the very first US Roadshow stop in Rockville, Maryland. ⚠️There is still time to subscribe. Don't miss out! RSVP Now: https://hubs.ly/Q02FcLdj0 #LifeScience #AITechnology #RegulatoryTrends #Sustainability #PQEGroup

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    🌍 EMA’s ISO IDMP Standards: What does it mean for pharmaceutical companies? The European Medicines Agency (EMA) is implementing standards developed by the ISO - International Organization for Standardization for the Identification of Medicinal Products (IDMP). Among other implications, it means that pharmaceutical companies must ensure their databases are updated and well-maintained with accurate and complete information. Business benefits are important in terms of regulatory compliance, but extend beyond, as the implementation of these standards can significantly improve corporate performance Andrea Bartolomei, Regulatory Operational Excellence Manager at PQE, has written a new blog on "Pharmaceutical Data Management: ISO IDMP with RIMS and eDMS," which elaborates on the systems themselves and the 𝗯𝗲𝗻𝗲𝗳𝗶𝘁𝘀 𝗼𝗳 𝘁𝗵𝗲𝗶𝗿 𝗶𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗶𝗼𝗻 𝗳𝗼𝗿 𝘆𝗼𝘂𝗿 𝗯𝘂𝘀𝗶𝗻𝗲𝘀𝘀! ➡️ https://hubs.ly/Q02FclKV0 #ISOIDMP #RegulatoryCompliance #DataManagement #EMA #SPOR #PQEGroup

    Navigating Pharmaceutical Data Management: ISO IDMP with RIMS and eDMS

    Navigating Pharmaceutical Data Management: ISO IDMP with RIMS and eDMS

    blog.pqegroup.com

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