Work in progress. On a very high level.

Hans-Peter Kost, Chairman of the Board of Directors of IQS AG in Zofingen, is convinced of Switzerland as a place to work: "There are many strong SMEs in this country that have positioned themselves excellently internationally with top-quality products. They make a significant contribution to the fact that 'Made in Switzerland' is highly regarded worldwide." Kost knows what he is talking about. His product IQSoft, Swiss through and through, convinces in over 1000 Swiss and 200 foreign companies and institutions as an electronic quality manager and not infrequently assists in the realization of ambitious goals. Also at MEDMIX Systems AG in Rotkreuz.

Certified quality for healthcare
The Zug-based medical company MEDMIX Systems AG develops mixing and application systems for multi-component biomaterials such as PMMA and calcium phosphate bone cement, tissue adhesives, fibrin glue and tissue sealant and has them produced externally in a "clean room". Areas of application: Orthopedics, vertebroplasty, vascular surgery, wound care and pharmaceuticals. MEDMIX is certified according to ISO 13485:2012/AC 2012 and consistently and successfully relies on IQSoft with SQL for continuous quality optimization. This was not always the case.

The better is the enemy of the good
René Oeschger, Quality System and Regulatory Manager and with MEDMIX since 2014, explains: "Like many other companies, we worked with Excel until a few years ago. Not fundamentally bad, but time-consuming and error-prone. If a path was accidentally changed, some things were hard to find. Traceability? A problem. And the fact that we kept unlinked data on different servers was a thorn in my side."

As an OEM supplier, MEDMIX Systems AG supplies its syringe systems to literally all the companies of distinction in the industry. 60 percent of the products currently go to the USA, the rest to Switzerland and neighbouring Europe. The company is currently building up the Asian market, where Swiss quality also has a very good reputation. Was the situation dramatic before you started using IQSoft? René Oeschger: "Not at all! A medical supplier simply can't afford real grievances. We are not certified according to ISO 13485 for nothing. This is a standard that in many respects goes far beyond the requirements of ISO 9001. But the time spent on quality management was far too high."

IQSoft and the FDA approval
MEDMIX is going all out. The Zug-based company wants to offer its customers "the whole package": "In the foreseeable future, we will approve our products ourselves with the U.S. Food and Drug Administration FDA in order to spare our customers this time-consuming process. The management decided to control the quality of all processes via IQSoft. The program was already installed when Oeschger joined the company, but was only used marginally:

"There was a lot to bring together. Not so much with our most important producer RIWISA. As a regulated company, they have been relying on IQSoft since 1999 and are always giving us tips on how to use the program optimally. We were concerned with the heart of the company. We research, develop and design and also have our own laboratory. We do cross-checks on product deliveries. We run sales, financials, and do quality assurance."

Work in Progress: the MEDMIX perspective
Oeschger describes what MEDMIX Systems AG is achieving with IQSoft for its 25 or so highly trained employees as a work in progress and is already looking ahead: "In November 2016, we will be recertifying. We want to meet new levels there." In view of the milestones already set and passed, this is a rather modest formulation. In the past 24 months, MEDMIX has been successfully audited by more than 30 customers and by TÜV, plus 10 of its own supplier audits. Always there: IQSoft.

The path to seamless quality management
René Oeschger describes point by point what he has changed and achieved with electronic quality management. Here is his overview:

Document Management:
All documents are immediately retrievable and no longer stored on some server. Each document has its own number instead of just a date. IQSoft allows individual documents to be checked out, adjusted and re-inserted. After the update, the now older version automatically moves to the archive.

Change system:
Records everything from material changes to document changes to supplier changes. Runs via document management.

Traceability:
100 percent guaranteed! A core service for cooperation with FDA inspectors.

Validations:
Need very clean processes. Are offered by MEDMIX Systems AG in different variants as a complete package, supported by IQSoft.

Contracting:
On the way to FDA approval, MEDMIX does not compromise on contracting either. IQSoft not only manages and links contracts with suppliers for the company, but also quality agreements and confidentiality rules.

Audits:
Thanks to electronic assistance, this can be mastered almost effortlessly, because a good electronic quality assistant adapts to individual needs. Everything is comprehensible. The upcoming three-year plan or previous internal and external audit reports are equally easy to access.

Pending issues, meetings and internal organization:
Everything is clearly defined. There are action groups for pending items. Whether it's an internal or external audit, an internal report, a supplier relationship, a meeting or a suggestion for improvement: nothing falls by the wayside, because IQSoft draws attention to it when something has not been done. The pleasant effect? Far fewer meetings, because everyone can see online at any time what still needs to be done.

Product Changes:
Product changes used to mean enormous effort. A "simple" material change can result in 27 measures within a workflow, which are then implemented point by point. IQSoft allows, among other things, the storage of measures, responsibilities, comments or drawings.

Error handling & improvement system:
IQSoft helps with supplier quality control. Repetitive errors become immediately visible where they were once difficult to detect due to lack of time. Since linking to the hourly rate, exactly quantifiable. Standards are reliably updated. Changes are seamlessly recorded and can be immediately displayed as an entire history. No manual updating. The full text search allows the use as a knowledge database.

Training:
MEDMIX simplifies the management of all training and further education with the IQSoft module Educ. This starts with the planning of internal and external trainings for new and long-term employees. This includes obligatory course repetitions and further training due to new processes. The bottom line is that all implemented and planned events can be tracked at any time at the click of a mouse.

External inspectors can see at a glance which of their employees and those of their suppliers are trained on which products.

Consolidation and more quality: in less time at all levels
René Oeschger: "We use IQSoft more intensively with every month. Everyone is enthusiastic and it is also well received externally. Especially our American friends are having fun. They find our Swiss quality thinking very impressive and IQSoft 'fantastic' and very simple. You always get very good results in audits with IQSoft." www.iqs.ch