Reach your goal with end-to-end digitization!

A well-known manufacturer of medical equipment (located in the Swiss Mittelland, name known to the editor) has already set the course for future-oriented business operations. As an innovative industry leader, it is consistently relying on the digitalization of its processes and a fully electronic management system. The focus of the system conversion was on ISO 13485 recertification and meeting the requirements of FDA 21 CFR 820. And all this without paper.

Automated workflow processes provide dynamic information control
The previous, partially digitized management system managed documents centrally on a server and required paper printouts with signatures to provide evidence in compliance with standards. The aim of the system conversion was to be able to manage all documents, processes and procedures of the company without the previous media discontinuity (software / paper) with an integrated management system. At the same time, a new level of efficiency was to be achieved with the help of automation. Despite increasing requirements, the maintenance effort is to be reduced and capacity for new tasks is to be generated (PostMarket Surveillance). In order for processes and documents (as desired for the medtech sector) to be checked and released fully electronically and individually managed for information distribution, the software solution used requires fully integrated workflow functionalities and electronic signatures based on the corresponding authentication (FDA 21 Part 11 compliant).

The choice of the optimal software therefore fell on IMS PREMIUM from IMS Integrierte Managementsysteme AG. From the automatic creation of PDFs and the stamping of documents to reading and training certificates, all processes can be controlled and documented fully electronically and therefore seamlessly. Monitoring and reminder functions support all participants in the timely processing of open tasks. The personalized dashboard also ensures a clear presentation of all user-related to-dos.

Processes come to life
One of the greatest advantages is clearly that processes, documents and tools are no longer statically mapped, but can be used dynamically through the connection of the quality management and workflow system. Processes, workflows and instructions thus "come to life". Step by step, the workflow can be processed electronically. Rule-based check steps, automatic information of involved parties and a complete documentation of the results enable a smooth workflow. By changing the process, the workflow can be adapted to new requirements and optimized for everyday use. At the same time, completely digital, standard-compliant verification is ensured at all times, without the need for even one paper printout. Further advantages of this dynamic way of working:

• Reduction of effort leads to a shorter lead time
• Fewer errors due to simple and automated processing
• Standardized process leads to consistent documentation and handling
• Regular use of the management system - the workflow is actively executed
• Individual design possibilities of processes to electronic, rule-based workflow

CAPA-compliant and yet flexible management of measures
ISO 13485 prescribes the systematic application of the CAPA process (Corrective and Preventive Action) in the company-wide quality management system. The aim of this process is to meet the requirements of regulations and laws on the safety of medicinal products and medical devices and to eliminate any deviations.

As part of the project, IMS PREMIUM was used to implement the paperless execution of the CAPA process. The corresponding workflow contains the process-controlled and rights-based implementation of measures based on roles and authorizations. Regardless of the problem - whether it is a customer complaint, process deviation, audit, suggestion for improvement, error in production or procurement - deviations and measures can be recorded and processed in a simple manner, either individually or as a whole. A documented customer complaint process, for example, becomes a workflow-controlled, fully electronic process. The preconfigured form allows the customer complaint to be entered via mobile phone, tablet or desktop computer and guides the parties involved step by step through the electronic processing. This functionality can be used for any process form and offers the following advantages:

• Transparency of all deviations and complete verification
• Measures management with tracking
  and comprehensive documentation
• Timely monitoring of CAPA and reminders to stakeholders

Evaluations for all management areas
In order to be able to keep the company-wide - in the case of larger organisations even cross-location - information management up to date, control and evaluate, a wide variety of evaluations should be possible. As an integrated management system, IMS PREMIUM offers all the possibilities of digital information consolidation, control and evaluation. In the case of the project described at the medical equipment manufacturer, status reports on open measures, applied standard chapters or even company goals are generated at the push of a button.

Demanding validation
Continuous digitization in accordance with ISO 13485 or FDA specifications requires complete documentation and the corresponding evidence of changes (change log) when placing on the market. This means that the software applications used to implement the management system must also be validated.

The following management system areas relevant to validation were identified in the project:

• Affected processes
• Impact on products and/or services of the company
• Functions of the management system that
  be used

IMS AG supported all phases of the project. From the planning with subsequent development of the utilization concept to the implementation of the completely digital management system. Based on the standardized procedure, the validation of the entire management system was carried out. With the use of IMS PREMIUM, in addition to the proof of a comprehensive implementation of the standard requirements and the guided documentation, it can also be shown that processes are really lived and corresponding specifications are implemented throughout the company.

Equipped for a paperless future
The path to a company-wide, completely digitalized management system was paved with many challenges. It was only thanks to the company-wide team effort and the technical support of the software partner that processes and procedures could be thought through, revised and sustainably designed across all divisions. But the effort was worth it: the process-controlled use of the management system is now an integral part of everyday work. And the best thing about it: Whether ISO 13485, MDR or FDA 21 CFR 820 - the dynamic management system is also ready for future requirements.