Impatti Negativi di Data Integrity sulle aziende Pharma Abbiamo sempre affrontato il tema Data Integrity dal punto di vista degli obblighi imposti dagli enti regolatori, da una parte, e dei benefici che si potranno ottenere, dall’altra. Ma come qualsiasi p... 17 juil. 2021
Qualità 4.0: Perché la cultura digitale deve essere di massima priorità per i QA Manager? Le forme della tecnologia avanzata sono ormai illimitate: Intelligenza Artificiale, Blockchain, IoT, Cloud, solo per citarne alcune. E sta cambiando rapidamente il modo in cui le aziende farmaceutiche... 4 juil. 2021
Applicazioni di IA nel farmaceutico Nell'articolo precedente " Quello che le macchine apprendono " abbiamo conosciuto i concetti fondamentali dell'intelligenza artificiale. Abbiamo visto che l'intelligenza artificiale, o meglio, Machine... 20 juin 2021
What machines learn Artificial Intelligence has been part of our reality for several years now. Each of us comes into contact with it every day, in a more or less conscious way. Movies suggested by Netflix, the most appr... 30 mai 2021
Are "Best Practices" still the best criteria for selecting and implementing an eQMS? The first Best Practices on Quality Management in Pharmaceutical Organizations date back almost 100 years. The book " The Principles of Scientific Management " by engineer Frederick Winslow Taylor, wh... 25 avr. 2021
The essential components of a modern eQMS software for pharmaceutical companies "The quality and production volumes are incompatible... if quality improves, volumes decrease, and vice versa... How much can we reduce quality without losing customers?" Thus begins the famous book "... QMS 25 mars 2021
The main trends in Quality Assurance to keep an eye on in 2021 The pharmaceutical industry is among the most conservative from the point of view of technological innovations. Even in digitization, the Life Science sector has always been the "tail-end". The FDA wa... QMS 12 mars 2021
How much does a paper-based QMS really cost? Paper might seem like a convenient option for managing production data, batch records, SOPs, trainings, CAPAs, change controls, validations, etc. Paper management is still widespread among many pharma... QMS 25 févr. 2021
Rispettare le normative FDA potrebbe essere più facile di quanto pensi Complying with FDA guidelines on Data Integrity may be easier than you think The official data integrity guidelines have been in full force for more than 5 years now. There is no Life Sciences profess... Data Integrity GmP 9 févr. 2021
The hospitals revolt against serialization The hospitals rebelion against serialization The current Falsified Medicines Directive (FMD) begins its history in 2011 and wants to replace the previous directive, issued in 2001. The culmination too... Serialization 11 janv. 2021
Tell me what you think about Data Integrity and I'll tell you who you are Tell me what you think about Data Integrity and I'll tell you who you are Many companies in the pharmaceutical sector see Data Integrity legislation as just an obligation to be respected. Indeed, as t... ALCOA Data Integrity IIoT laboratorio analisi 29 mai 2020
The greatest obstacle to Data Integrity The greatest obstacle to Data Integrity Have you ever wanted to literally observe a datum along its journey through business processes? Do you think it is impossible? Since the Data Integrity requires... ALCOA CFR21 Data Integrity IIoT 13 mai 2020