Medical Device Development: Process Safety Management

September 25, 2015

webinar-150513-medical-336x336 Medical Device Development: Process Safety Management medical Software quality, safety and reliability are crucial for medical device development. There are some important requirements that should be considered if it comes to process safety. We need to establish traceability for all steps performed and for each intermediate step taken during development. We should be capable to trace what happened at a specific certain time. We need to define clear responsibilities and have clear descriptions for both status and process. Secure processes are the prerequisite of safe development. It ensures that the procedures are always the same and run just as wanted.

The most important Requirements for Process Safety

  • Identical procedures: If we work with paper instead of software mistakes could easily happen. A process could be done differently by new/changing employees and/or by employees that do not have sufficient knowledge about the process.
  • Defined processes and workflows: Before starting a workflow step, we must define the whole process. If we have a workflow with 25 steps, we must define when and what steps need to be taken to display the correct information. It makes no sense, for example, to do risk analysis without the necessary processes.
  • Traceability: We should trace all steps carried out. Traceability should include the person performing the work, the date and all the information available at that point in time.
  • Responsibilities: Each process step should be carried out exclusively by an employee who has the relevant knowledge.
  • Clear descriptions for status and process steps: In many cases, the only the people who know the processes are those people who created them. We should ensure that each process is unambiguous and clear to everyone involved.

Besides that, requirements should be well defined and clear to all. Employees are key to ensure compliance with requirements and should adhere to all relevant information, hold responsibilities and fulfill any documentation obligations. It is impossible to be done in a regular (manual) way without making mistakes.

How to Ensure Process Safety with codeBeamer ALM Software

ALM software is a great alternative to meet requirements, ensure traceability and compliance with relevant standards. codeBeamer ALM software enables you to easily define processes and workflows. You can customize workflow and work item fields. You can also enjoy the benefits of advanced configuration options including triggered notifications and guards with e-signatures to adapt your business processes to your requirements and internal processes.

Using codeBeamer ALM software you can easily request relevant information before process steps through the configuration of status-related mandatory fields as well as easily track the statuses and changes of processes. You can grant permission to people based on fields, processes and roles to ensure that only person who has the sufficient knowledge carries out changes and process steps. Finally yet importantly, our Traceability browser provides a fast overview of processes.

Check out our video to see how codeBeamer can support your medical device development.

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Related E-Book

Intland's Medical IEC 62304 Template

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Eva Johnson

Written by

Eva is an Economist (MSc) and also holds an MBA in Marketing Communications. She has over 10 years of experience in journalism, digital media communication and project management working with several multinational companies and governmental institutions. You will find her blogs posts on a variety of subjects from Agile-Waterfall Hybrid, Scrum to DevOps.

Eva Johnson has written 131 posts for Intland Software.

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