Urgent NIS-2 Directive: New cybersecurity obligations for companies — are you ready? Learn more →

Quality Management:

Quality Management
Standards Make Everyday Life Easier.

Through clearly defined and lived work processes, recurring activities are carried out in consistently high quality.

Quality Management

Standards Make Everyday Life Easier

Thanks to clearly defined and consistently lived work processes, recurring activities are carried out reliably and in consistently high quality. This standardisation forms the foundation for reliable results and enables continuous improvement measures. Increase the quality of work results, systematically optimise your work processes and enhance employee and customer satisfaction. We are happy to advise you on the creation of suitable guidelines and processes that fit your organisation.

Building & Establishing Competence

As a competent partner, machCon supports you in all areas of IT quality management in understanding the regulatory requirements relevant to your organisation and integrating them into your quality management system. We do not press your structures into a rigid framework, but build on what is already in place. Most organisations live processes but have not yet formally documented them. This is exactly where we come in, supporting you in building a framework with the appropriate guidelines and processes that fit your needs — using the industry standards suitable for your organisation (ISO 9001, ISO 13485, GAMP 5, ITIL, etc.). Planning an ISO certification? Our experts are happy to guide you step by step and ensure you successfully complete the certification.

Mergers & Acquisitions IT

Integrations and spin-offs of companies present a particular challenge for the organisations involved. Years of experience in mergers, acquisitions, integrations and divestments in regulated environments makes machCon a reliable partner. We support IT quality activities in the areas of: integrations (acquisitions), sales (divestitures), spin-offs and the development of a compliance framework for M&A IT activities.

Our Services

Our Quality Management Services

As part of our quality management services, we offer you the following options.

Guidelines & Processes

machCon supports you in analysing regulatory requirements (21 CFR Part 820, 21 CFR Part 11, EU GMP Annex 11, ISO 13485, etc.) and helps you derive appropriate measures and map them in guidelines and processes. We also support you in analysing and developing your existing quality management system.

Mergers & Acquisitions IT

In the context of M&A IT activities, machCon experts support you in developing a compliance framework based on your quality management system. Our experts also support you in quality management-related activities in M&A IT projects to ensure that all applicable processes are followed and regulatory requirements are met.

Quality Assurance

Throughout the entire lifecycle of an IT system, machCon experts support you in implementing quality management-related activities through to IT quality assurance. We ensure that your IT system is validated according to requirements and that the validated state is maintained until decommissioning.

Inspection Readiness

An independent assessment by machCon experts can help you prepare for IT audits and regulatory inspections. Together with your internal experts, we define the content of such an assessment, carry it out and produce a report. We are also happy to support you in defining and implementing corrective measures based on the findings.

Computerised System Validation

To ensure that an IT system is ready for its intended use, machCon experts support you in all validation activities. We ensure that the system functions as specified, meets the company's requirements and complies with all relevant applicable rules and regulations.

ISO Certifications

machCon supports you in your certification activities and helps you derive the necessary measures and map them in guidelines and processes. We also offer to carry out an assessment to identify any weaknesses so they can be addressed before the actual certification audit.

Our Clients

Our Clients

" Fantastic business analysts! I am absolutely delighted to have machCon involved in my projects. They have an incredible drive and are solution-oriented while maintaining a friendly and positive working atmosphere. "


Novartis Pharma AG

Reference Customer

" machCon is like Maverick from TopGun! I have to say I would choose to work with machCon again and again. We have had very good experiences with their project managers, coordinators, business analysts and technical experts. "


Roche Pharma Research IT

Reference Customer

" Highly qualified project managers. I worked with machCon on a major project and was absolutely satisfied with the performance. The project manager did a great job and integrated seamlessly into the entire team. "


Sandoz International GmbH

Reference Customer

Contact

Contact Us for More Information

We are happy to advise you personally on your quality management requirements and show you how machCon can support your organisation.

Christian Herbst

CEO machCon Deutschland GmbH & machCon GmbH · Dipl. Computer Scientist, BSc, PMP©

Quality as a Competitive Advantage?

Start today with a non-binding conversation about your quality management.