High-quality work, a transparent product lifecycle and flows governed by standards are indispensable components in medical technology. Each phase in the product lifecycle has its own requirements using different processes, information and employees.
IMS PREMIUM enables the networking of a variety of information and functions across entire organizational structures and distribution systems. Modular in structure, it offers exactly the functionality which is needed at the current time, and remains flexible in order to also be able to meet future requirements.
Our solutions
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Customizable process modeling of simple to highly complex processes
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Configurable workflows for authorization-driven process, document and measure releases
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End-to-end, continuous improvement process with measures management
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Standards and Legislation Management for the introduction and maintenance of ISO 13485
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Paperless and complete documentation in accordance with FDA Title 21 CFR Part 11
Benefits for you
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Modularly structured system, expandable and customizable in accordance with the company's needs |
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Documentation of all operating areas, from research and development to production and sales |
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Mapping of complete product lifecycle including evaluations and reports for audits |
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Cross-country, cross-site and cross-departmental process management and document control with versioning |
Mapping of processes
Process maps, modeling of cross-location standard or individual processes. User-oriented display by means of individual favorite processes. Deviations from the previous version can be seen at a glance.
Document management
Free design of documents and easy integration of existing documents. Authorization-related control of documents thanks to complete versioning and individual release workflows.
Structuring of organization
Overview of responsibilities through a complete and cross-site presentation of the organizational structure including job profile and dynamically linked staffing.
Continuous improvement
Quick entry and processing of complaints and suggestions for improvement. Holistic processing of customer requests, including controlling and improvement.
Management of risks
Risk management across all areas from production to real estate management. Simple ICS implementation including evidence.
Standards and Legislation Management
Linking documents, processes, measurements, organizational structures, risks and KPIs with standards elements. Evaluation for efficient audits at the press of a button.
Case Study
Meet your goals with continuous digitalisation (ISO 13485 and FDA 21 CFR 820)
ISO 13485 certification and fulfilling all requirements of FDA 21 CFR 820 - paperless!