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Opus (tm) QMS

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robert_allan_james

The document describes Opus, a quality management software system being developed by The Software Foundry Ltd. for the medical device manufacturing industry. It is seeking funding to be ready by late 2011. Opus will integrate applications like document control, training management, and auditing into a single system to reduce costs and staffing needs while ensuring regulatory compliance. Screenshots show examples of features like user administration, a dashboard for tasks, and file version control.

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Opus TM QMS A Quality Management system for the Medical Device manufacturing industry. The Software Foundry Ltd. is PROUD to present
To Our Investors The Software Foundry Ltd. is currently seeking capital in order to help bring this vitally needed product to market. We anticipate that with proper funding, this product would be production ready by the end of the 2 nd quarter of 2011. Please remember that an enterprise wide system such as Opus not only reduces QS staffing needs, but is very GREEN!
What is Opus? A Quality Management System 21 CFR Part 11 Compliant 21 CFR Part 820 quality systems manager ISO 13485 features are integrated Manage Document Control Manage Training Manage Validations, CAPA, FMEA, Post Market and more
Why Opus Quality systems are often disjointed and use many applications to accomplish the required activities. Staffing requirements are also quite large. Opus integrates these applications, and activities into one enterprise wide system that will reduce your risk to regulatory noncompliance issues, as well as your staffing requirements. Opus is ideally suited to meet regulatory needs for your organization.
Why Opus (continued) Opus will centralize your quality system needs while ensuring that information is disseminated on a need to know basis. Opus provides reporting and auditing of your QS. Information is readily available to auditors, managers, and QS personnel. Opus reduced the staffing requirements for your QS Opus id Green as well. Reducing paper files is ALWAYS good!
What about the Future? The Software Foundry Ltd. Is planning several other products to compliment Opus QMS. Opus Mobile will keep your managers in touch 24/7. Opus Purchasing will tie your supply chain into your QS, allowing for greater process control. Opus LEAN will allow you to apply Lean Manufacturing disciplines in your process. Opus Project will help you with the transfer of R&D into manufacturing. (Opus already provides some of this functionality)
Still In Development The following slides present an approximation of what Opus will look like in your organization. Currently, as this product is still in development, the screen shots are only a representation of what the future will hold for your organization.
Log In Page Currently English, French and German are supported. Other languages will be integrated As needed. Custom language support is also available.
Administrative Settings System administration is easy and provides all necessary functions to the QMS.
User Administration Users can be fully managed, including which modules they have access to, and account status.
Profile Editor Each system user has a profile that is used to identify them to other users.
Dashboard A users dashboard will display all current tasks assigned for that user to work on, This will include any documents that need attention As well as any training that needs to be completed, and any other tasks generated by the system.
File Browser This is a view of a folder/file browser
File Uploading When uploading files to the system, checking the controlled file checkbox will place the file into a workflow that is persistent for the life of the file.
File Versions This is an example of the versioning done by the Opus Content management module. This example depicts a file that is NOT in a workflow.

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Opus (tm) QMS

  • 1. Opus TM QMS A Quality Management system for the Medical Device manufacturing industry. The Software Foundry Ltd. is PROUD to present
  • 2. To Our Investors The Software Foundry Ltd. is currently seeking capital in order to help bring this vitally needed product to market. We anticipate that with proper funding, this product would be production ready by the end of the 2 nd quarter of 2011. Please remember that an enterprise wide system such as Opus not only reduces QS staffing needs, but is very GREEN!
  • 3. What is Opus? A Quality Management System 21 CFR Part 11 Compliant 21 CFR Part 820 quality systems manager ISO 13485 features are integrated Manage Document Control Manage Training Manage Validations, CAPA, FMEA, Post Market and more
  • 4. Why Opus Quality systems are often disjointed and use many applications to accomplish the required activities. Staffing requirements are also quite large. Opus integrates these applications, and activities into one enterprise wide system that will reduce your risk to regulatory noncompliance issues, as well as your staffing requirements. Opus is ideally suited to meet regulatory needs for your organization.
  • 5. Why Opus (continued) Opus will centralize your quality system needs while ensuring that information is disseminated on a need to know basis. Opus provides reporting and auditing of your QS. Information is readily available to auditors, managers, and QS personnel. Opus reduced the staffing requirements for your QS Opus id Green as well. Reducing paper files is ALWAYS good!
  • 6. What about the Future? The Software Foundry Ltd. Is planning several other products to compliment Opus QMS. Opus Mobile will keep your managers in touch 24/7. Opus Purchasing will tie your supply chain into your QS, allowing for greater process control. Opus LEAN will allow you to apply Lean Manufacturing disciplines in your process. Opus Project will help you with the transfer of R&D into manufacturing. (Opus already provides some of this functionality)
  • 7. Still In Development The following slides present an approximation of what Opus will look like in your organization. Currently, as this product is still in development, the screen shots are only a representation of what the future will hold for your organization.
  • 8. Log In Page Currently English, French and German are supported. Other languages will be integrated As needed. Custom language support is also available.
  • 9. Administrative Settings System administration is easy and provides all necessary functions to the QMS.
  • 10. User Administration Users can be fully managed, including which modules they have access to, and account status.
  • 11. Profile Editor Each system user has a profile that is used to identify them to other users.
  • 12. Dashboard A users dashboard will display all current tasks assigned for that user to work on, This will include any documents that need attention As well as any training that needs to be completed, and any other tasks generated by the system.
  • 13. File Browser This is a view of a folder/file browser
  • 14. File Uploading When uploading files to the system, checking the controlled file checkbox will place the file into a workflow that is persistent for the life of the file.
  • 15. File Versions This is an example of the versioning done by the Opus Content management module. This example depicts a file that is NOT in a workflow.