Technical report: Achieving goals through continuous digitalization
ISO 13485 and FDA 21 CFR 820
Particularly in the medical technology sector, but also in other industries, regulatory requirements and thus administrative costs continue to rise. In order to keep pace with ISO 13485 and the requirements of the MDR (Medical Devices Regulation), a dynamic, flexible and cost-efficient approach is required. Static, paper-based management systems can no longer keep up.
Automated workflow processes ensure dynamic information management
The previous, partially digitalized management system managed documents centrally on a server and required paper printouts with signatures to provide proof in accordance with standards. The aim of the system changeover was to be able to manage all of the company's documents, processes and procedures with an integrated management system without the previous media disruption (software / paper). At the same time, a new level of efficiency is to be achieved with the help of automation. Despite increasing requirements, the maintenance effort is to be reduced and capacity is to be generated for new tasks (post-market surveillance). In order for processes and documents (as required for the medtech sector) to be checked and approved fully electronically and to be individually managed for information distribution, the software solution used requires fully integrated workflow functions and the electronic signature based on the corresponding authentication (FDA 21 Part 11 compliant).
The choice of the optimal software therefore fell on IMS PREMIUM from IMS Integrated Management Systems AG. From automatic PDF creation to document stamping and proof of reading and training, all processes can be controlled and documented fully electronically and therefore seamlessly. Monitoring and reminder functions support all those involved in processing open tasks on time. The personalized dashboard also ensures a clear display of all user-related to-dos.
Processes come to life
One of the biggest advantages is that processes, documents and tools are no longer statically represented, but can be used dynamically by connecting the quality management and workflow systems. Processes, workflows and instructions "come to life". The workflow can be processed electronically step by step. Rule-based testing steps, automatic information of those involved and complete documentation of the results enable a smooth process. By changing the process, the workflow can be adapted to new requirements and optimized for everyday use. The completely digital, standard-compliant provision of evidence is guaranteed at all times, without even the need for a paper printout. Other advantages of this dynamic way of working are
Individual design options for processes to create electronic, rule-based workflow
CAPA-compliant yet flexible action management
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 drug and medical device safety and to eliminate any deviations.
As part of the project, the paperless processing of the CAPA process was implemented with IMS PREMIUM. The corresponding workflow includes the process-controlled and rights-based implementation of measures based on roles and authorizations. Regardless of the problem - whether customer complaint, process deviation, audit, suggestion for improvement, error in production or procurement - deviations and measures can be easily recorded and processed individually or together. A documented customer complaint process, for example, becomes a workflow-controlled, fully electronic process. The preconfigured form enables the customer complaint to be recorded via mobile phone, tablet or desktop computer and guides those involved step by step through the electronic processing. This functionality can be used for any type of process and offers the following advantages
Evaluations for all management areas
In order to keep the company-wide information management up to date, to control it and to evaluate it - in larger organizations even across locations - a wide range of evaluations should be possible. As an integrated management system, IMS PREMIUM offers all the options for digital information consolidation, control and evaluation. In the case of the project described at the medical device manufacturer, status reports on open measures, applied standard chapters or even company goals are generated at the push of a button.
Demanding validation
Consistent digitization in accordance with ISO 13485 or FDA specifications requires complete documentation and the corresponding evidence of changes (change log) when placing a product 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:
IMS AG supported all phases of the project. From planning and subsequent development of the usage concept to the implementation of the completely digital management system. The validation of the entire management system was carried out on the basis of the standardized procedure. By using IMS PREMIUM, in addition to proving comprehensive implementation of the standard requirements and controlled documentation, it can also be demonstrated that processes are really being implemented and the corresponding specifications are being implemented company-wide.
Prepared 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 designed sustainably across all departments. 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: regardless of whether it is ISO 13485, MDR or FDA 21 CFR 820 - the dynamic management system is also ready for future requirements.