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konplan – How to Save Time and Money Through Professional Validation

konplan

konplan is a one stop solution provider of mechatronic engineering solutions to the pharmaceutical and medical industries. The company offers design and development services as well as product development and automation of small and medium sized test and production systems.

What makes cooperation with konplan particularly rewarding is the excellence in solution oriented thinking, the quality driven methodology and the consequent focus on efficiency. Most projects are characterized by co-creation and collaboration with a network of customers, solution providers and specialized production firms.

konplan’s culture of positive thinking and it’s ambition for open, honest and respectful relationships gives support to complex and challenging projects. Being a Swiss company, the team feels particularly obliged to deliver the highest quality at all times and undertakes continuous effort for best improvement and reliability in delivery and pricing.

The wide range of services in the areas of electronics, mechanics and software is complemented by consulting and verification & validation expertise. The company offers documentation, risk analysis, testing, system integration and qualification services. konplan’s success is based on highly skilled and experienced teams of software and mechanical
engineers, all working closely together with testing and validation specialists.

The company produces work according to common international certification systems, including ISO 9001 and
ISO 13485. konplan is ideal for quality-driven, forward-looking SMEs and big players alike seeking a highly qualified, reliable, flexible, hands-on partner with a broad profile.

Efficient Validation for Track & Trace Systems for SME

konplan 2

SMEs with worldwide customers are confronted with an increasing number of regulatory requirements. When new standards are requested, the effort and time for adaptation especially have to be kept as small as possible.

At the same time, the standards have to be met precisely. The following example illustrates how a successful cooperation in the pharma packaging industry can work:

A service provider for packaging of pharmaceutical products was responsible for introducing new equipment for track and trace to one of its customers.

Regulatory requirements demanded three different packaging units be identified separately with individual "barcodes". Tasks to be completed included the validation of the internet data interface between the production company and the packaging provider, ensuring full data integrity according to part 11 / annex 11 was provided. Moreover, the different stakeholders needed to be supported in synchronizing their different validation processes.

The greatest challenge of the project was not to actually do it, but to implement it efficiently and economically. On first evaluation, an extensive and costly project was predicted. Due to their T&T (Track & Trace) experience, combined with specific knowledge of technical systems, standards and methodologies, the konplan validation experts worked out a much less time-consuming concept for validation and proved this during the project. Thanks to their high level of expertise and the capability to reduce complexity, the konplan team helped to save a lot of time and money.

konplan

"I am proud of my highly skilled team. They are very engaged and bring together a lot of experience. They make things look easy. This creates confidence and trust."

Andy Tonazzi, CEO konplan

Plant Validation of Production Facilities – Reducing to the Max

When supplying equipment for medical device or pharmaceutical production, machine manufacturers typically need to provide development documentation and to have compliant development processes.

konplan

One of konplan’s validation projects required documentation and testing of a production facility for automatically inserting ampullas into a disposal device. The ampullas were designed to deliver different dosages, making the preciseness of the liquid dosage a critical factor.

In cooperation with the machine manufacturer, konplan implemented a risk management process consisting of multiple levels. Before starting the validation, a high level risk assessment was carried out. Here the most critical points in terms of patient safety were evaluated and rated. The result was a significantly shortened list of requirements, that, from a CSV perspective, were required to be rated in detail. The approach to generate this list was to suspend all activities that fell under the GEP, as they were not needed to be validated. Here again the process of assessment and rating demanded high expertise, combining very specific mechanical, soft- and hardware-knowledge that was only possible with a well cooperating interdisciplinary team of specialists.

Because efforts were concentrated in the relevant areas a lot of time was saved. Consistent application of Gamp 5 and risk management were the key to optimizing the documentation required by the regulator. The selected procedure allowed not only the delivery of the facility on time but also fulfilled the quality expectations of the operator.

konplan

"We like very much how the konplaner’s listen, think, pilot and do"

Lorenz Binggeli, Qualitymanager IT, B. Braun Medical AG

Working consistently within an extensive number of similar projects, konplan has developed into a full service provider for verification and risk analysis in the product development sector.

konplan

In the production area, documentation and verification compliant with GAMP 5 is a special strength, including all qualification works for the subsequent launch.

As the practical experience of konplan’s specialists is being continuously enhanced, excellent value for money can be expected by customers each and every time.

 

konplankonplan systemhaus ag
Grundstrasse 4b
CH-6343 Rotkreuz
Tel: 0 800 0 13485
www.konplan.com
info@konplan.com

 

 

 

 

 

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