konplan offers manufacturers and technical providers in the pharmaceutical market practical mechatronic experience and a broad range of skills. 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 its excellence in solution-oriented thinking, quality-driven methodology, and consequent focus on efficiency. Most projects are characterised by co-creation and collaboration with a network of customers, solution providers, and specialised 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 and 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 small to medium enterprises (SME), as well as big players seeking a highly qualified, reliable, flexible, hands-on partner with a broad profile.
Efficient validation for track and trace systems for SMEs
SMEs 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, high-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 synchronising 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 track and 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 the company’s high-level of expertise and the capability to reduce complexity, the konplan team helped to save a lot of time and money.