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Quality management

We will structure and organise your quality management.

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QUALITY MANAGE­MENT

Overview of services

For more than 15 years we have been improving our customers’ quality management. In close cooperation with you, we support you in individual projects in the improvement of your QM system up to and including the complete assumption of responsibility (QM representative) for your QM system.

Another focus of our work is the rectification of deficiencies from audits and inspections of already existing quality management systems.

Quality assurance manual

Production of your firm’s own quality assurance manual incl. all SOPs necessary for your company

SOPs

Production of SOPs for special tasks such as, among others, quality management, quality assurance, distribution, sales, returns, company start phase, etc.

Training of employees

We conduct online training, adapted to your needs, in your quality management system. Upon request we will also train your employees on site.

Audits

Audits of external partners such as e.g. contract manufacturers, logistics partners, study facilities, etc. The conducting of internal audits of your departments is also part of our service portfolio. These audits can be carried out remotely or on site.

Setting up and maintenance of QM systems

An SOP system describes a company’s quality objectives and processes. Particular attention here needs to be paid to the precise demarcation of all responsibilities. Each company is different, so no SOP system is the same as another.
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Specially tailored GxP SOP systems

Do you want to become a wholesaler or pharmaceutical entrepreneur?

Based on our many years of experience, we produce an individual SOP system specially tailored to your wishes and the legal requirements for your company. Of course, we also offer our support for existing systems, for checking that they are up-to-date and in compliance with the legal requirements.

Training in the pharmaceutical industry

Regardless of whether you are setting up a new quality management system (QMS) or have already implemented one, regular training and further training of employees is indispensable.

We conduct training for your employees in all quality-related matters, on the basis of your QM system. Your employees get to know their SOP system even better and are instructed on how to keep in mind and implement quality requirements. Beyond this, we train them to carry out the process of producing or revising an SOP independently, so that improved and changed procedures are independently recorded, edited and described in revised SOPs by the individual departments. And if difficulties still occur, we can intervene to provide support.

Our range of services comprises training

in the QM system (according to ISO 13485)

in the production and revision of SOPs

in the putting into writing of work procedures / procedural instructions

on laws (e.g. AMG, MPG, etc.)

on EU regulations

on guidelines (e.g. GDP, GVP, etc.)

Following all training, a test is carried out to monitor success. We offer to set up a software system for online success monitoring.

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Office

Thaerstraße 4a
47533 Kleve

Opening hours

Mo-Fr: 8:30 a.m. – 1:00 p.m.
Mo-Fr: 2:00 p.m. – 4:30 p.m.

Phone

+49 (2821) 7277-0