e-signature Experts Talk

31 Jan 2019

Experts Talk: Tool Validation per FDA Title 21 CFR Part 11

In this webinar recording, Intland Software’s partner expert Kálmán Keresztesi (Controsys Ltd.) proposes a convenient, preconfigured solution to the Title 21 CFR Part 11 tool validation challenges related to codeBeamer ALM in regulated industries.

Previous Experts Talks

safety-critical-maturity Experts Talk

Achieving Safety-critical Development Maturity with Agile/DevOps ALM (featuring Ovum)

In this on-demand webinar, Ovum’s Principal Analyst Michael Azoff analyzes the market context of increasing Agile/DevOps adoption in safety-critical industries. This Experts Talk webinar also includes insights of a BMW case study conducted by Ovum for a recent white paper.

medical-agile Experts Talk

Roundtable Discussion: Agile in Medical Technology

Experts: Jared Miller, Alan Schachtely, Sarb Singh-Kaur, Kelly Weyrauch
This discussion covers the challenges and benefits of applying Agile practices in the development of cutting-edge medical technology.

fmea-risk-management Experts Talk

FMEA & Risk Management in Practice

Expert: Adela Beres
Learn how to analyze, evaluate and manage the risks during development to avoid systematic failures in your system.

Hazard Analysis and Functional Safety Compliance

Expert: Adela Beres
A systematic and structured approach to hazards analysis is crucial to identify Safety Goals and their related ASILs as an input for the development of safety related products.

hazard-analysis-and-compliance Experts Talk
test-automation Experts Talk

Test Automation Utilizing Legacy Test Data and Maintaining Safety-critical Compliance

Expert: Matt Davis
Learn from QA Systems and Intland Software experts how to save time and costs by automating testing processes, how to utilize your existing test data in a new ALM environment, and how to ensure traceability and compliance with safety-critical standards and regulations.

Requirements-driven Test Automation & ISO 26262 Compliance in Automotive Development

Expert: Pierre Henri Stanek
Meeting safety and regulatory requirements in the automotive industry forces developers to adopt increasingly rigorous Quality Assurance processes. Requirements-based testing is a key QA method that helps ensure high product quality with minimal costs, and compliance with automotive regulations such as ISO 26262.

iso26262-in-automotive-development Experts Talk
pharmaceutical-alm Experts Talk

Using Pharmaceutical ALM for GAMP 5 Compliance

Expert: Kálmán Keresztesi
Pharmaceutical companies face challenges when setting up distributed control systems or automated production systems for pharmaceutical products. In addition to pharma companies, suppliers of pharma production devices and system integrators are also facing the challenge of complying with GAMP®.

ASPICE® and ISO26262 – Achieving Compliance in the Automotive Industry

Expert: Thomas Arends
The realization of complex products for the automotive industry is a challenge. Key topics for achieving compliance with ASPICE ® and ISO 26262 are traceability, data consistency and safety culture. Ensuring compliance with the above while creating safe and mature development processes requires that we keep complexity as low as possible.

aspice-iso26262 Experts Talk

The Experts

azoff Experts Talk

Michael Azoff


adela-beres Experts Talk

Adela Beres

Freelancer Safety Expert

davis Experts Talk

Matt Davis

QA Systems

sarb-singh-kaur Experts Talk

Sarb Singh-Kaur


keresztesi-kalman Experts Talk

Kalman Keresztesi


jared-miller Experts Talk

Jared Miller


alan-schachtely Experts Talk

Alan Schachtely

Bigfoot Biomedical

stanek Experts Talk

Pierre Henri Stanek

QA Systems

kelly-weyrauch Experts Talk

Kelly Weyrauch

Agile Quality Systems

thomas-arends Experts Talk

Thomas Arends

Intland Software