White Papers

Presentation material: FDA Data Integrity-CSA Part Two Webinar (Mar 16 2021)

Presentation Material used in this live webinar with Data Integrity panelists, on March 16. During the webinar, we learnt how CSA can be adapted to benefit your organization and the application of Data Integrity.

Presentation material: FDA Data Integrity-CSA Part One Webinar (Jan 26 2021)

Presentation Material used during this live webinar on January 26 with the FDA (CDER & CDRH) discussing Data Integrity challenges and CSA application.

Presentation material from CSA Revolution Season Two (Episode I) on November 18 2020

Presentation Material used during this live webinar on November 18 with the Data Integrity panelists discussing how data integrity can be used with CSA

Presentation material from CSA Revolution Webinar Series (Episode VI) on September 17 2020

Presentation Material used during this live webinar on September 17 with Lantheus Medical Imaging & the FDA discussing how to overcome Organizational Culture Barriers with CSA

21 CFR Part 11 ERES Requirements

Build all of the ERES requirements into your Requirements Specification template. Include appropriate subsections: Open Systems, Closed Systems Audit Trails; Nonbiometric Signatures, Biometric Signatures and Procedural. Populate the template will every possible ERES requirement. Simply determine if that system must adhere to 21 CFR Part 11, and which subsections (groups of requirements) are applicable.

Presentation material from CSA Revolution Webinar Series (Episode V) on September 3 2020

Presentation Material used during this live webinar on September 3 with Boston Scientific discussing their CSA case study for preventative maintenance / calibration system

Presentation material from CSA Revolution Webinar Series (Episode IV) on August 20 2020

Presentation Material used during this live webinar on August 20 with Medtronic discussing their CSA case study of automating risk-based processes

Presentation material from CSA Revolution Webinar Series (Episode III) on August 6 2020

Material used during this live webinar with Fresenius Medical Care on August 6 discussing their CSV to CSA journey

Presentation material from CSA Revolution Webinar Series (Episode II) on July 23 2020

Material used during this live webinar with Johnson & Johnson on July 23 discussing their CSA journey with MES case study (Manufacturing Execution Systems)

Everything about FDA's draft guidance on Computer Software Assurance (CSA)

A comprehensive White Paper on everything you need to know about the FDA's upcoming draft guidance on Computer Software Assurance (CSA). Includes key lessons from CSA implementations.

Presentation material from Webinar with the FDA on April 23rd 2020 on CSA

Material used during the Webinar with the FDA on April 23rd on the topic of Computer Software Assurance (CSA) and how companies can shift from CSV to CSA.

Compliance Group’s prior CSA presentations with FDA & Clients

Numerous case studies from Compliance Group’s clients and the FDA from previous industry presentations. Slides include Siemens Polarion paperless validation tool case study from Medtronic.

Navigating the EU MDR Maze

This comprehensive white paper can be helpful for medical device companies to strategically update their risk management process to not only satisfy the requirements of the 3rd Edition of the ISO 14971 standard, but to improve their risk management process.

Are you prepared for the latest version of ISO 14971:2019?

This comprehensive white paper can be helpful for medical device companies to strategically update their risk management process to not only satisfy the requirements of the 3rd Edition of the ISO 14971 standard, but to improve their risk management process.

Accelerate collaboration with unified requirements management

Ever-growing customer expectations for innovation amplify the challenges companies face in today’s competitive business environment. While the increased ratio of software in modern products has accelerated innovation, it has also intensified complexity and risk.

Moving to Enterprise Agile – Seven lessons learned in Agile

The key mistakes made in Agile software development are tied to the inability to improve the process continuously, mainly because most purportedly Agile organizations are not able to make a shift in their mindsets. Through the introduction of Enterprise Agile, corporations and other large organizations see the opportunity to finally have the full benefit of Agile adoption.

How an integrated ALM tools approach can expedite CMMI compliance

This white paper discusses the capabilities of Polarion® application lifecycle management (ALM) software from Siemens PLM Software, and how this comprehensive solution can help you bring your organization to Capability Maturity Model Integration (CMMI) Maturity Level 2 or Level 3.

Fill in the form below

Subscribe to Compliance
Group via Email

  • Our Services
  • Engagement Models
  • Siemens Polarion
  • iQuality
  • Lab-Informatics
  • About us
  • Why us
  • Webinars
  • Get in Touch
  • Privacy policy
  • Complianceg MSA

Copyright © 2021 Compliance Group All rights reserved.