Aura

Quality Compliance Monitoring &
Process Management System

Automated Audit Management Solution for Medical Appliances Manufacturer Bookmark and Share

aura-casestudy-medicalappmanufacture Client
Client is one of the leading Manufacturer of medical appliances instruments. They manufacture appliances for measuring, checking, testing, navigating and all-purpose instruments except optical instruments.

Business Requirement
Client’s core requirement was to have a solution that should be effectively handle their multiple Audit checklist with minimal manual intervention. The proposed system should be time saving & should also provide tangible benefits that leads to continual improvements to their Quality Management system.

Solution offered
The Client was provided with Aura -Web based QMS software that helps them to effectively monitor & manage their regulatory compliance activities & expose ineffectiveness in the existing system. Also brings improvements in process by Specialized Assessment Management Module, which brings customer satisfaction and new improvement initiatives.

Client's Core Requirement was the Audit Checklist creation; this can be done Process wise & the QMS user can select particular checklist for individual department audits too.
 
Aura's Specialized Assessment Management module allows the QMS User / Authorized user to create all processes like Design & Development, Production, Assembly which are all applicable to the organization. Once the Process creation operation is completed then Process wise parameters can also be created in the same way.

QMS user will have flexibility to choose applicable processes for any particular department Audit. In the same way they can also create any no of department audits by choosing the Process wise parameters this will be one-time effort.

While scheduling audit the system facilitates the QMS user to choose Audit checklist name alone and facilitates in allocation of Audit by selecting the Auditor, Auditee & Audit schedule with the appropriate selection of Audit checklist in less timeframe.  Once the schedule is created and published, the system automatically allocates the task to Auditor & Auditee in their respective calendar view. This greatly helps in their planning & execution in an effective way. In this way, AURA saves lot of time in multiple audit checklists creation & allocation of audit schedule to QMS users.

Benefits
  • Automation of Process wise parameters and checklist creation
  • Mapping Department Wise Audit checklist with suitable process wise parameters leads to save huge time for QMS users in creating multiple department audit checklists.
  • System made Audit scheduling & schedule will be listed to Auditor & Auditee calendar view as notification
  • Increased visibility between the various stake holders (QMS User, Auditor & Auditee)
  • Huge time saving & Avoid paper based existing system gaps in running their Operational activities such as Process wise parameter creation, Multiple Audit checklist creation & Audit scheduling

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