Systems development life cycle

3-Hour Virtual Seminar on Risk Based Approach to IT Infrastructure Qualification, Compliance & Control

Retrieved on: 
Tuesday, December 19, 2023
SDLC, Documentation, Risk assessment, Computer, Quality control, Risk, Software, Systems development life cycle, Research, Consultant, System, FDA, Software as a service, GxP, Tobacco, Control, W3C Markup Validation Service, Medical device

DUBLIN, Dec. 19, 2023 /PRNewswire/ -- The "3-Hour Virtual Seminar on Risk Based Approach to IT Infrastructure Qualification, Compliance & Control" webinar has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Dec. 19, 2023 /PRNewswire/ -- The "3-Hour Virtual Seminar on Risk Based Approach to IT Infrastructure Qualification, Compliance & Control" webinar has been added to ResearchAndMarkets.com's offering.
  • These include all systems that "touch" product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA.
  • It will cover the approach for validating/qualifying infrastructure components to FDA-regulated systems, including cloud-based servers and Software-as-a-Service (SaaS) solutions.
  • This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

3-Day Virtual Computer System Validation (CSV) Certification Course: Comprehension of the FDA Regulations Impacting your Systems and Hands-on Practice Writing Validation Documents - ResearchAndMarkets.com

Retrieved on: 
Tuesday, November 14, 2023
Technology, Pharmaceutical, Health, Other Technology, Cloud, ICH, EudraLex, Research, Test, Exercise, Risk, Business, Biotechnology, Tobacco, CSV, FDA, Q&A, Documentation, System, PQ, Computer, Boot camp, Risk assessment, Compliance training, Systems development life cycle, Software, Comprehension, SDLC, GxP, Quality control, COTS, OQ, Boot Camp (software), Medical device, Risk management

The following exercises will be included in the course content and can be completed at each attendee's discretion.

Key Points: 
  • The following exercises will be included in the course content and can be completed at each attendee's discretion.
  • If completed before the end of the Boot Camp, the attendee may ask questions during any Q&A session.
  • If completed after the Boot Camp, the attendee may ask questions via Compliance Trainings and a response will be sent as quickly as possible.
  • The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.

EDETEK Launches CONFORM™ Statistical Computing Environment (SCE)

Retrieved on: 
Wednesday, December 6, 2023
SCE, Senior, TLF, Language, Informatics, Statistics, CDISC, Movement, Product strategy, Metadata, Trial of the century, Freedom, SDLC, GXP, Systems development life cycle, Data, Environment, Drug development, Video game

PRINCETON, N.J., Dec. 6, 2023 /PRNewswire/ -- EDETEK Inc., a leading global provider of modern clinical technology solutions and services for the biopharmaceutical, medical devices and CRO companies, announced today a new innovative product in the CONFORM™ Informatics Platform - Statistical Computing Environment.

Key Points: 
  • CONFORM™ Statistical Computing Environment (SCE) was built to solve many challenges faced by clinical programmers and statisticians.
  • "CONFORM™ SCE enables clinical programmers to maximize the power of the CONFORM™ Informatics Platform.
  • SCE accelerates clinical study reporting, submission, analysis and statistical modeling while having access to fully integrated CONFORM™ modules for real time data ingestion from 70+ popular clinical and medical systems.
  • The platform not only provides regulatory compliance functions and controls, but also manages tasks through an intuitive integrated development environment, enhancing the efficiency of clinical programmers' daily tasks.

3-Hour Virtual Seminar on Computer System Validation (CSV) vs. Computer Software Assurance (CSA): Learn About FDA's Approach to Modernizing Technology, and Benefits for Both the Agency and Industry

Retrieved on: 
Wednesday, November 22, 2023
Quality, PMI, Software craftsmanship, Organization, Risk management, Roma Education Fund, Risk, CSA, Patient, Tobacco, Guide, Agency, Checklist, CSV, FDA, AITP, Documentation, Agile, Automation, Risk assessment, Quality management system, Systems development life cycle, Software, SDLC, GxP, Waterfall, Knowledge, Volunteering, Thought, Device, Medical device, Design

A key element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) Waterfall approach.

Key Points: 
  • A key element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) Waterfall approach.
  • The attendee will learn about FDA's approach to modernizing technology, and how that will benefit both the Agency and industry.
  • This approach is amenable to the Agile software development methodology, which can be adapted for use in validation.
  • She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

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

Retrieved on: 
Friday, October 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.

Computer System Validation (CSV/CSA), 21 CFR Part 11, Data Integrity/Privacy Compliance for FDA-Regulated Systems (Richmond, VA, United States - August 14-15, 2023)

Retrieved on: 
Thursday, May 25, 2023
SDLC, Systems development life cycle, Software as a service, Infrastructure as a service, Platform as a service, Microsoft Excel, CSA, Service level, Computer, Risk assessment, Privacy, Thought, Organization, Second Edition, Documentation, Patient, GxP, Service-level agreement, GDPR fines and notices, Title 21 CFR Part 11, System, Google Sheets, SLA, FDA, Environment, COTS, HIPAA, W3C Markup Validation Service, Software, Medical device, Risk management

DUBLIN, May 25, 2023 /PRNewswire/ -- The "Computer System Validation (CSV/CSA), 21 CFR Part 11, Data Integrity/Privacy Compliance for FDA-Regulated Systems" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, May 25, 2023 /PRNewswire/ -- The "Computer System Validation (CSV/CSA), 21 CFR Part 11, Data Integrity/Privacy Compliance for FDA-Regulated Systems" conference has been added to ResearchAndMarkets.com's offering.
  • This webinar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each.
  • In discussing these hardware and software options, we'll include the best practices for meeting FDA's requirements for validation, 21 CFR Part 11, as applicable, and data integrity.
  • The attendee will learn how to validate systems to meet 21 CFR Part 11, and data integrity compliance.

Computer System Validation for Cloud and COTS Applications Webinar: Learn About FDA's Approach to Modernizing Technology

Retrieved on: 
Monday, May 15, 2023
Cloud, Online, SDLC, Systems development life cycle, Checklist, Software as a service, Infrastructure as a service, Platform as a service, SLA, FDA Center for Devices and Radiological Health, Gentlemen's agreement, QMS, CSA, Service level, Risk management, Risk assessment, Quality, Ship, Thought, Organization, US, Quality management system, Documentation, CSV, Platform, Patient, GxP, Agency, Risk, Service-level agreement, Title 21 CFR Part 11, Knowledge, Device, FDA, Environment, COTS, W3C Markup Validation Service, Automation, Software, Medical device, Design, Property management

DUBLIN, May 15, 2023 /PRNewswire/ -- The "Computer System Validation for Cloud and COTS Applications - Live, Online Training" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, May 15, 2023 /PRNewswire/ -- The "Computer System Validation for Cloud and COTS Applications - Live, Online Training" training has been added to ResearchAndMarkets.com's offering.
  • The attendee will learn about FDA's approach to modernizing technology, and how that will benefit both the Agency and industry.
  • We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products.
  • A key element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) waterfall approach.

Two Weeks Until the Introduction to Computer System Validation Course (April 17-18, 2023)

Retrieved on: 
Friday, April 7, 2023
SDLC, Systems development life cycle, Maintenance, Software as a service, Probability, CSA, Biotechnology, Computer, Risk assessment, CFR, Documentation, CSV, GxP, Risk, Title 21 CFR Part 11, System, FDA, COTS, Software, Medical device, Risk management

DUBLIN, April 7, 2023 /PRNewswire/ -- The "Introduction to Computer System Validation" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, April 7, 2023 /PRNewswire/ -- The "Introduction to Computer System Validation" training has been added to ResearchAndMarkets.com's offering.
  • We'll talk about CSA and how to validate cloud, COTS, SaaS, and other systems and maintain them in a validated state.
  • This will include a discussion around waterfall, agile, and other methodologies for system development, testing, and validation, including how to apply automated testing to your approach.
  • Understand FDA's new draft guidance on Computer Software Assurance (CSA) and how to apply this to your approach to validation, focusing on critical thinking.

flox Raises $27 Million, Introduces Open Source Platform to Bring Nix to Everyone

Retrieved on: 
Tuesday, February 7, 2023
Automation, Organization, Security, Systems development life cycle, Sotheby, SBOM, Catalog, Microsoft, Software, SDLC, Flox, Environment, Sotheby's, NEA, New Enterprise Associates, Cryptocurrency, Online shopping, Docker, GitHub, Addition, Nix

NEW YORK, Feb. 7, 2023 /PRNewswire/ -- flox, the company bringing the power of Nix to everyone, today announced it has raised $16.5 million in its Series A led by New Enterprise Associates (NEA), bringing total funding to date to $27 million. flox was incubated at DESCOvery, the D. E. Shaw group's venture studio, and its early backers include Addition and Hetz Ventures. Notable angel investors include Thomas Dohmke, CEO at Github; Guy Podjarny, founder of Snyk; and James Turnbull, former CTO at Microsoft for Startups and VP at Docker, currently CTO at Sotheby's.

Key Points: 
  • The company today is also introducing its new open source flox platform and is expected to release its enterprise platform later this year.
  • By creating an easy-to-use platform around Nix, flox supercharges productivity for developers everywhere while also making their software more secure."
  • "We're excited to partner with Ron and his talented team as they continue to expand and roll out their new open source platform to bring Nix to everyone."
  • "The platform is still used at the D. E. Shaw group today, and we're excited about the value that we believe flox can bring to developers everywhere."

3 Day Online Computer System Validation for Cloud and COTS Applications Training Course (March 3-5, 2023)

Retrieved on: 
Thursday, February 2, 2023
Cloud, Online, Software as a service, Organization, Infrastructure as a service, Agency, Thought, Title 21 CFR Part 11, Service-level agreement, Documentation, Patient, Software, Service level, Systems development life cycle, SDLC, SLA, CSV, GxP, Platform as a service, FDA, COTS, Risk assessment, Environment, W3C Markup Validation Service, Video game, Medical device

DUBLIN, Feb. 2, 2023 /PRNewswire/ -- The "Computer System Validation for Cloud and COTS Applications-Live Online Training" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Feb. 2, 2023 /PRNewswire/ -- The "Computer System Validation for Cloud and COTS Applications-Live Online Training" training has been added to ResearchAndMarkets.com's offering.
  • This webinar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each.
  • We'll also cover COTS, SaaS, IaaS, PaaS, and cloud services, indicating the benefits and risks of each model.
  • We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products.