Title 21 CFR Part 11

US Government Contractor Selects ValGenesis VLMS After Rigorous Audit of Digital Validation Solutions

Retrieved on: 
Mardi, octobre 31, 2023
Documentation, Environment, Policy, Education, Economic development, Health, Title 21 CFR Part 11, Research, Medical device

SANTA CLARA, Calif., Oct. 31, 2023 /PRNewswire/ -- ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), today announced that a US government contractor selected ValGenesis VLMS to digitize its corporate validation process.

Key Points: 
  • SANTA CLARA, Calif., Oct. 31, 2023 /PRNewswire/ -- ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), today announced that a US government contractor selected ValGenesis VLMS to digitize its corporate validation process.
  • The company sees ValGenesis VLMS as an important tool to maintain a current and audit-ready state of its clinical applications.
  • Assured that operations become more streamlined and documentation contains clear audit trails compliant with 21 CFR Part 11/Annex 11 regulations, the company chose ValGenesis VLMS to serve as its system of record for the validation of its critical business applications.
  • We are glad to have earned our customer's trust to help them create fully automated, transparent, and audit-ready corporate validation processes."

Online Computer System Validation (CSV/CSA) Course: Navigating Changing Landscapes - 21 CFR Part 11, Data Integrity/Privacy Compliance for FDA-Regulated Systems

Retrieved on: 
Vendredi, octobre 27, 2023
Patient, Systems development life cycle, FDA, Google Sheets, Software as a service, Documentation, Microsoft Excel, HIPAA, Thought, COTS, Environment, GxP, Commercial, Risk assessment, Platform as a service, Privacy, Infrastructure as a service, W3C Markup Validation Service, Computer, GDPR, SDLC, Title 21 CFR Part 11, CSA, Head, Medical device, Risk management

DUBLIN, Oct. 27, 2023 /PRNewswire/ -- The "Computer System Validation (CSV/CSA), 21 CFR Part 11, Data Integrity/Privacy Compliance for FDA-Regulated Systems" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Oct. 27, 2023 /PRNewswire/ -- The "Computer System Validation (CSV/CSA), 21 CFR Part 11, Data Integrity/Privacy Compliance for FDA-Regulated Systems" training has been added to ResearchAndMarkets.com's offering.
  • Join us for an insightful webinar that explores the shifting paradigms of software development, validation, and system maintenance in a continuously changing environment.
  • Learn how to leverage modern technology while remaining compliant with FDA regulations for computer systems and data.
  • Gain insights into validating systems to meet 21 CFR Part 11 and data integrity compliance.

Sphere Fluidics’ Cyto-Mine System Selected by FairJourney Biologics to Advance Cell Line Development Workflows

Retrieved on: 
Mardi, octobre 3, 2023
Biotechnology, Pharmaceutical, Health, Medical Devices, Immortalised cell line, GLP, Sphere Fluidics, Therapy, Research, Sphere, Engineering, Drug discovery, Title 21 CFR Part 11, Knowledge, Cell engineering, FDA, Synthetic biology, Vaccine

FairJourney Biologics has adopted the platform as part of the launch for its latest cell line development services, to streamline and accelerate customer workflows.

Key Points: 
  • FairJourney Biologics has adopted the platform as part of the launch for its latest cell line development services, to streamline and accelerate customer workflows.
  • FairJourney Biologics’ team of experts comprises an extensive knowledge of cellular biology, enabling them to tailor cell lines precisely to their partners' unique requirements.
  • Leveraging state-of-the-art technologies and meticulous quality control measures, FairJourney Biologics consistently delivers high-performing, stable cell lines that serve as the foundation for efficient antibody production and therapeutics development.
  • The integration of Sphere Fluidics’ Cyto-Mine platform into our cell line development workflows enables us to best cater to our partners’ needs, to provide high-quality, customized cell lines in a fraction of the time.”

Emmes Introduces Telehealth Capabilities into Advantage eClinical

Retrieved on: 
Mercredi, septembre 27, 2023
Title 21 CFR Part 11, Information, GDPR, EMMS International, Software as a service, HIPAA, Perception, Clinical data management, Patient, DCT, Workflow, Public, Contract research organization, EDC, Medical imaging, Online shopping

ROCKVILLE, Md., Sept. 27, 2023 /PRNewswire/ -- Emmes, a global, full-service Contract Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announces the addition of telehealth capabilities within Advantage eClinical. The new application means any scheduled visit can become virtual with video calls augmented directly through the platform and patients signing in through their existing participant portal. Advantage eClinical is designed to enable a simple, intuitive experience that fits seamlessly into the everyday lives of study participants and sites.

Key Points: 
  • ROCKVILLE, Md., Sept. 27, 2023 /PRNewswire/ -- Emmes, a global, full-service Contract Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announces the addition of telehealth capabilities within Advantage eClinical .
  • Advantage eClinical is designed to enable a simple, intuitive experience that fits seamlessly into the everyday lives of study participants and sites.
  • The addition of telehealth capabilities is part of a much wider development plan for Emmes' third generation clinical data platform.
  • "What we are building with Advantage eClinical is more than an EDC or eCOA/ePRO.

Emmes Introduces Telehealth Capabilities into Advantage eClinical

Retrieved on: 
Mercredi, septembre 27, 2023
Title 21 CFR Part 11, Information, GDPR, EMMS International, Software as a service, HIPAA, Perception, Clinical data management, Patient, DCT, Workflow, Public, Contract research organization, EDC, Medical imaging, Online shopping

ROCKVILLE, Md., Sept. 27, 2023 /PRNewswire/ -- Emmes, a global, full-service Contract Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announces the addition of telehealth capabilities within Advantage eClinical. The new application means any scheduled visit can become virtual with video calls augmented directly through the platform and patients signing in through their existing participant portal. Advantage eClinical is designed to enable a simple, intuitive experience that fits seamlessly into the everyday lives of study participants and sites.

Key Points: 
  • ROCKVILLE, Md., Sept. 27, 2023 /PRNewswire/ -- Emmes, a global, full-service Contract Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announces the addition of telehealth capabilities within Advantage eClinical .
  • Advantage eClinical is designed to enable a simple, intuitive experience that fits seamlessly into the everyday lives of study participants and sites.
  • The addition of telehealth capabilities is part of a much wider development plan for Emmes' third generation clinical data platform.
  • "What we are building with Advantage eClinical is more than an EDC or eCOA/ePRO.

Intelligent Bio Solutions Obtains ISO Recertification for its Intelligent Fingerprinting Drug Screening Business

Retrieved on: 
Mercredi, septembre 27, 2023
US Foods, QMS, Benzodiazepine, ISO, Buprenorphine, Research, Certification, Organization, Cocaine, Methadone, Cannabis, Growth, Title 21 CFR Part 11, Health, Intelligence, Food, Substance abuse, Medical device

NEW YORK, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced that its Intelligent Fingerprinting Drug Screening business has obtained recertification for the latest ISO 13485: 2016 harmonized quality management system standard for the medical device industry.

Key Points: 
  • NEW YORK, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced that its Intelligent Fingerprinting Drug Screening business has obtained recertification for the latest ISO 13485: 2016 harmonized quality management system standard for the medical device industry.
  • “We are currently focused on driving sales growth for our Intelligent Fingerprinting Drug Screening System across Europe and Australia.
  • The Intelligent Fingerprinting business has also been recertified for the ISO 9001:2015 quality standard.
  • The Intelligent Fingerprinting Drug Screening System is designed to detect the presence of specific drugs and/or their metabolites from fingerprint sweat.

Clario teams up with CellCarta to transform clinical trial sample management for histopathology studies

Retrieved on: 
Mardi, septembre 26, 2023
CT, Partnership, Gastroenterology, NASH, Clinical trial, Pathology, PET, CFR, Crohn's disease, MRI, SOP, UC, Title 21 CFR Part 11, Quality control, Biopsy, Software, Medical imaging, Clario Tech

PHILADELPHIA, Sept. 26, 2023 /PRNewswire/ -- Clario, a healthcare research technology company that delivers the leading endpoint technology solutions for clinical trials, proudly announces a strategic partnership with CellCarta, experts in integrated sample management and specialized laboratory services. Together, Clario and CellCarta are set to make significant strides in improving clinical trial sample handling, ensuring seamless operations and unprecedented access within Clario's innovative platform.

Key Points: 
  • Clario and CellCarta's strategic partnership enhances clinical trial sample handling and digitization within Clario's web-based 21 CFR Part 11 compliant platform.
  • Together, Clario and CellCarta are set to make significant strides in improving clinical trial sample handling, ensuring seamless operations and unprecedented access within Clario's innovative platform.
  • CellCarta's clinical trial sample management offers kit provisioning and sample accessioning, processing, digitization, and quality control.
  • To explore the future of clinical trial sample management and learn more about Clario's transformative healthcare research technology, visit Clario.com .

Clario teams up with CellCarta to transform clinical trial sample management for histopathology studies

Retrieved on: 
Mardi, septembre 26, 2023
CT, Partnership, Gastroenterology, NASH, Clinical trial, Pathology, PET, CFR, Crohn's disease, MRI, SOP, UC, Title 21 CFR Part 11, Quality control, Biopsy, Software, Medical imaging, Clario Tech

PHILADELPHIA, Sept. 26, 2023 /PRNewswire/ -- Clario, a healthcare research technology company that delivers the leading endpoint technology solutions for clinical trials, proudly announces a strategic partnership with CellCarta, experts in integrated sample management and specialized laboratory services. Together, Clario and CellCarta are set to make significant strides in improving clinical trial sample handling, ensuring seamless operations and unprecedented access within Clario's innovative platform.

Key Points: 
  • Clario and CellCarta's strategic partnership enhances clinical trial sample handling and digitization within Clario's web-based 21 CFR Part 11 compliant platform.
  • Together, Clario and CellCarta are set to make significant strides in improving clinical trial sample handling, ensuring seamless operations and unprecedented access within Clario's innovative platform.
  • CellCarta's clinical trial sample management offers kit provisioning and sample accessioning, processing, digitization, and quality control.
  • To explore the future of clinical trial sample management and learn more about Clario's transformative healthcare research technology, visit Clario.com .

Cyclotron Announces New Technology Triage Initiative for Healthcare & Life Science Organizations

Retrieved on: 
Vendredi, septembre 22, 2023
Online, Data management, GitHub, Maintenance, Communication, Health, M365, GCP, ICH, Risk, Confidentiality, PII, Microsoft Power Platform, Certification, Organization, GxP, SAN, Title 21 CFR Part 11, PHI, GDPR, HIPAA, Medical device, Nursing, Video game, EU, Cyclotron

SAN FRANCISCO, Sept. 22, 2023 /PRNewswire-PRWeb/ -- Frontline healthcare is a 24/7 industry that has a limited capacity to adopt change and is staffed by large non-technical user groups that rely on sensitive patient data to do their jobs. The task of understanding and governing these diverse health data sets—which are often spread across different sources—is very challenging. Add to that the need to integrate, manage, and analyze that data in compliance with HIPAA and GDPR regulations, and difficulties and risks become even greater. Meanwhile, cybersecurity threats, such as ransomware, add a whole additional layer of risk, and the loss or mismanagement of PII and PHI can have costly consequences.

Key Points: 
  • "Great tools are readily available to help today's healthcare and life sciences workers adequately manage the data, communications, and risk factors facing their organizations.
  • Underpinning this commitment is Cyclotron's recent GxP audit certification as a cloud solutions provider for healthcare and life sciences verticals.
  • "Great tools are readily available to help today's healthcare and life sciences workers adequately manage the data, communications, and risk factors facing their organizations.
  • On the life sciences side of the healthcare industry, inefficient collaboration, version control issues, and lengthy development cycles for healthcare software all represent opportunities for a partner like Cyclotron to bring transformative improvements and bottom-line results to healthcare organizations.

Leading Clinical Informatics Experts at EDETEK and Pfizer Partner at DPHARM Conference

Retrieved on: 
Lundi, septembre 18, 2023
Data management, Associate Director of National Intelligence and Chief Information Officer, Aggregation, Vehicle tracking system, American Opportunity Tax Credit, Conformity, Clinical trial, Innovation, Electronic health record, Doctor of Philosophy, Movement, MS, Disruptive innovation, Patient, ESourcing Capability Model, Access, Acquisition, Title 21 CFR Part 11, Data acquisition, GDPR, Satellite navigation device, Pharmaceutical industry, Pfizer

PRINCETON, N.J., Sept. 18, 2023 /PRNewswire/ -- EDETEK Inc., a leading global provider of specialized software and services for the biopharma, devices and diagnostics industries, announced today that it will participate in a prestigious plenary roundtable session of the 2023 DPHARM (Disruptive Innovations to Modernize Clinical Research) conference. This session takes place during DPHARM Track A, on Tuesday, September 20, 2023 at 2:50pm ET.

Key Points: 
  • "Central to our relationship with Pfizer is our implementation of EDETEK's CONFORM™ informatics platform," said Mr. Baara.
  • The EDETEK CONFORM™ platform has emerged as a transformative business and technical solution for increasingly complex clinical trials.
  • Pfizer and EDETEK are collaborating to speed access to clinical data, promote interoperability and enable data visualizations and analytics to drive faster decision-making capabilities in clinical operations.
  • "We have participated in every DPHARM conference since 2017 and are once again very excited to participate in the 2023 conference," said Jian Chen, President, EDETEK.