ERP industry software + ECM/DMS + QM processes
Quality processes for medical technology
How about you...
- could digitize your quality management end-to-end
- could complete all QM-relevant tasks on one platform - without the time-consuming switching between programs and without double data entry
- through seamless integration, all QM, QA and QC processes could be carried out directly in your ERP industry software
- Could provide your employees with a solution that guides them step by step through complex QM processes
- You would work with an IT platform that you can adapt modularly and easily to your business goals
An integrated platform for all tasks in medical technology
The KUMAVISION quality platform offers you a holistic solution that covers all requirements in the field of medical technology.
This unique blend of a revolutionary ERP industry software built on the leading technology platform Dynamics 365 Based on Microsoft, a smoothly integrated ECM/DMS solution and a wealth of QM processes is the guarantee for regulatory security and effortless audits.
The quality platform simultaneously forms the foundation for efficient business processes, real relief for your employees, continuous transparency and up-to-date KPIs as well as limitless flexibility and adaptability.
- All applications on one platform
- Ready for MDR, ISO 13485, FDA, UDI, ...
- No data silos, no interfaces
- User-friendly integration with Microsoft 365
- Modular structure, flexibly expandable
- Powered by KUMAVISION and Microsoft Dynamics 365
ERP
ERP industry software for medical technology
Hundreds of best practice processes for purchasing, sales, production, warehouse and logistics, customer service, complaints and repairs, financial accounting and controlling.
ECM/DMS
ECM/DMS with ELO
Secure storage of data and information, digital document management, rapid information availability, automated business processes - including seamless ERP integration
QM processes
All relevant QM processes completely digitalized
QA, QM and QK. Direct integration into all business processes. Secure mapping of regulatory requirements such as MDR, ISO 13485, FDA.
Flexible platform
One platform for all tasks
The QM platform is based on the technology platform Microsoft Dynamics 365. Flexibly combine ERP, CRM for sales, service and marketing, business intelligence, office, teams...
Your individual quality management system
Use the KUMAVISION industry solution for medical technology to map your company-specific requirements for a quality management system (QMS) for medical technology flexibly, time-savingly and safely.
- Directed documents such as quality management manuals, SOPs, work instructions, process documentation, dangerous goods data sheets: DMS with file tree structures and rights management
- Evidence documents such as order confirmations, invoices, production orders: Audit-proof document storage in the DMS with direct integration into the ERP software
- Product life cycle: Project management, MDR functionalities, DMS with file tree structure and rights management as well as release workflows
- Training and qualifications: Training and qualification module in the DMS
- Validation: Comprehensive range of advice and services from KUMAVISION
- Change management: Project management, workflow and notification manager including ECM/DMS integration
- Process management: Define and document processes, evaluations, derived projects and measures
- Key figures and reporting: Direct integration of Microsoft business intelligence software Power BI
- Manage approvals and certificates: MDR document control with DMS integration
- Complaints and complaints: Complaints and complaints management with DMS integration
- Failure Mode and Effects (FMEA): FMEA module according to ISO 13485, ISO 14971, MDR and FDA
- Correctivce and Preventive Actions (CAPA): Action management according to ISO 13485, ISO 14971, MDR and FDA
- Process control: work and notification manager, follow-ups
- Compliance: release control and digital signature
- Data quality: Mandatory field check, differentiated blocking of master data
- Internal and external audits: Audit module (e.g. supplier audits) and document storage
- Test equipment: Test equipment management and test equipment groups
- Calibration: Calibration specifications and calibration files
- Check error: Error codes and error categories
- Entrance exam: Incoming goods inspection with quarantine
- Process check: Workplace or work process-related testing
- Final test: Final inspection in production
- Manual check: Manual inspection in the warehouse
All test orders with individual test plans and traceable test plan management
Ready for national and international standards, regulations and legislative requirements:
- ISO 1384.
- MDR
- FDA
- UDI
- GAMP5
- EUDAMED and GUDID
- ...
Do I really need a separate QM suite?
KUMAVISION QM platform | External QM suite | |
|---|---|---|
Preface | One partner for all applications | Multiple software partners, multiple interfaces and more time and coordination required |
Deliverables | All relevant QM requirements Always included: ERP industry software, ECM/DMS and optionally other Microsoft applications | Product and provider dependent. Complex solutions with higher functionality available. Some with highly specific functions that are rarely or never needed in practice. |
Ease of use | Uniform Microsoft interface, direct integration into Office, Outlook and Teams, targeted user control, cross-application workflows | Different interfaces, ERP and Office integration only via interfaces |
Maintenance | Cloud-Solution, maintenance by KUMAVISION, automatic updates | Depending on the provider, higher effort due to heterogeneous IT environment |
Costs | Transparent prices for complete solutions | Usually higher, different contractual partners, operation and maintenance more complex |
Automation | Automated integration of QA, QM and QC into all business processes including document control | Often limited or only with individual programming |
expandability | Flexibly expandable, easily scalable, no code/low code solutions | Often limited or only with individual programming |
Basic | Microsoft Dynamics 365-Platform with numerous business applications | Proprietary base |
Consulting | Through providers, sometimes with external partners | Through providers, sometimes with external partners |
7 reasons for the KUMAVISION quality platform
- Digitalization of the entire product life cycle on a software platform
- Seamless integration of ERP software, ECM/DMS and QM processes
- Secure mapping of QM, QS and QC as well as regulatory requirements
- Digital storage of all documents from the idea to the end of the product
- Powerful workflows and easy-to-use task controls
- Full integration with Microsoft 365, e.g. B. Outlook and Teams
- Flexible automation of QM-relevant processes