COETIC votre partenaire pour la gestion et la validation de vos projets réglementés GxP

Google a étendu la disponibilité de son API "Cloud Healthcare" dans le but d'améliorer l'interopérabilité des soins de santé et d'aider les fournisseurs à obtenir des informations à partir d'une myriade de sources de données médicales. L'API Cloud Healthcare de Google permet aux organismes de santé de collecter et de gérer différents types de données médicales via le cloud, notamment les normes DICOM (Digital Imaging and Communications in Medicine),  Health Level 7  et  Fast Healthcare interoperability Resource . Ces données peuvent être alimentées par des programmes d'analyse et de machine learning afin que les prestataires de soins de santé puissent identifier des modèles qui pourraient les aider à améliorer les soins aux patients. Link to article - CLICK HERE

By  Kip Wolf , Tunnell Consulting,  @KipWolf To begin, it is important to understand that data quality and data integrity are not the same thing. Data quality may be defined as the general utility of a data set as a function of its ability to meet the requirements for its use. This definition includes relativity that may also be explained as bias, which simply means that context is necessary to fully interpret and understand the data. Data quality is very specific to the data set and the data itself and, if measured to be poor, may be improved through verification, transformation, and/or cleanup. Data integrity is about trust and is as much about the supporting systems and processes as it is about the data set and the data itself. Data integrity relates to the state of the data or the sensitivity of data to external influence or change... Link to article - CLICK HERE

3. Failure to establish an adequate quality control unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)). Your quality unit (QU) did not have adequate procedures describing the appropriate oversight of your manufacturing operation. For example, you lacked written procedures describing the review of test records, raw electronic data, and batch production records prior to approval and release...

Today, the European Commission has adopted a  proposal  to postpone by one year the date of application of the  Medical Devices Regulation  to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic. This decision takes into account the unprecedented challenges of the coronavirus pandemic and the need for an increased availability of vitally important medical devices across the EU whilst continuing to ensure patient health and safety until the new legislation becomes applicable. Vice-President for Promoting our European Way of Life, Margaritis  Schinas , said:  “Shortages or delays in getting key medical devices certified and on the market are not an option right now. The Commission is therefore taking a pragmatic approach and delaying the entry into application of new EU rules on medical devices, so we can have our medical industries pouring all their energy into what we need them to ...

2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)). Your firm receives raw material, " (b)(4) " as a component for use in production of  (b)(4) . This raw material is a  (b)(4)  containing  (b)(4) , the active ingredient in your finished drug product. Though you receive this raw material with a certificate of analysis from your supplier, you have not performed appropriate incoming analysis of component lots upon receipt, including confirming the identity prior to use in production of your finished drug product. You also relied on your supplier's Certificate of Analysis without establishing the reliability of your component supplier's test analyses at appropriate intervals . Link to WL - CLICK HERE

1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). Your firm did not maintain complete and accurate data from all laboratory testing. Without reliable laboratory data, you cannot assure appropriate decisions regarding batch release, product stability, and other drug aspects of quality. For example: a. On May 19, 2018, the peak detection function was disabled multiple time s during the gas chromatography (GC) residual solvent testing of your incoming active pharmaceutical ingredient (API),  (b)(4)  batch  (b)(4) . After reviewing the chromatograms, our investigators noted unknown peaks that were not reported or integrated as required per your procedure. Our investigators requested your firm to reprocess the sample set sequence, which subsequently showed >  (b)(4) % total unknown impurity peaks. You used this b...

Technologie :  Le département de recherche d'IBM a mis au point une nouvelle méthode de détection des cancers du sein reposant sur l'usage de l'intelligence artificielle. Une avancée majeure pour la santé publique ? Une étude récente menée par le département de recherche d'IBM a révélé comment la combinaison d'algorithmes d'apprentissage automatique et d'évaluations de radiologues pouvait améliorer la précision globale des dépistages du cancer du sein. Selon Stefan Harrer, chercheur à IBM, les mammographies, couramment utilisées par les radiologues pour la détection précoce du cancer du sein, reposent souvent sur l'expertise d'un radiologue pour identifier visuellement les signes du cancer, ce qui ne s'avère pas toujours précis. « Dans l'état actuel de l'interprétation humaine des images de mammographie, deux choses peuvent se produire : un diagnostic erroné en termes d'absence de cancer et aussi un diagnostic de cancer lorsqu...