Software Validation Utilizing Principles of Lean Documents and Lean Configuration

Overview:

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.

New approaches to software validation will help avoid many of the structural costs with a major endeavor by removing legacy methods that applied to paper systems.  This will also set the stage for further integration with other software systems and modules.

With the increased need to automate many Quality Management System (QMS) and manufacturing processes, as well as medical devices themselves, software validation has continued to come to the forefront in terms of design controls, process controls, supply chain management, and almost every process currently involved in medical devices.  This is happening while AI and robots continue to also proliferate in the general business, marketing, and sales arena.

One trend is that often controlled documentation is embedded into the software itself and these may not have received the scrutiny of their paper document counterparts in terms of controls and review.

With the increased burden on software from every direction, the traditional ways of configuring information are becoming obsolete artifacts of a paper-based era.  A new approach to software configuration and validation is needed to set the stage for this new era of information and the internet of things (IOT).

Areas Covered during the session:

• Software configuration
• General setup
• Organization
• User Management
• Rights Groups, Roles, and Actors
• Products
• Processes
• Failure Modes, Process Signals, Tasks
• Screens, menus, and modules
• Process validation steps

Why should you attend:

You will soon be overwhelmed by continuing to apply paper document methods and approaches to software configuration and validation.

Rather than wait to be surprised by unexpected situations, or to implement requirements haphazardly, it is better to understand what the hands-on challenges of dynamic requirements as they push the boundaries of technology and new applications.

If you are already constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, and now realize a different way is needed, this webinar is something that will give you a different perspective and a very different approach that you can use.

This webinar is an overview of the coming changes and their implications, using a new approach yet is based upon solid principles and proven practices.

Who should attend:

Medical Device professionals including

• Regulatory
• Quality
• Compliance and Regulatory
• Compliance Expert
• Software Engineer
• Software Engineering Manager
• Medical Device Software Compliance
• Medical Device Software
• Quality Assurance
• Design Assurance
• Design Engineers