Achieve Digital Compliance
In Life Science

Zamann Pharma support is a trusted consulting company and software developer exclusively specializing in the life science industry.

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Our employees are adaptable to the demanding and constantly changing environment. Customer infrastructures make for a strong foundation for future success and a close partnership.

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Our Services

Trackwise Global Roll Out Run Organization Demand Management Project Management Computer System Validation Environmental Monitoring 4.0

Our services mainly concentrate on Trackwise, an application developed by Sparta Systems, which is used globally as a quality management system. Our specialists have first-class technical knowledge about the software and can support your company from the first steps in development, through to ongoing support for your business following implementation.

Establishing a training program during the deployment phase is decisive for users’ future satisfaction and for them working efficiently. Problems in this section can lead to serious consequences during the Hyper care Phase, which may not just cause showstoppers, but may also endanger the entire establishment of the system. To reduce the insecurity of the users to a minimum, as well as to eliminate potential risks completely, the harmonization of the development and deployment phase is a vital part of a carefully adjusted and mature training concept.

Our expertise includes the creation of user concepts to be considered when specifying the configuration and during the development phase, as well as the production of training materials and e-learning modules and the preparation, training, and support of users and corresponding user communities. Even long-established systems often have plenty of room for improvement in this area and the training concept can be modified and improved for each unique situation.

An established GxP system needs a lot of support. The complexity of the system and its processes inevitably lead to a large volume of queries from the users. The numerous possible combinations of fields, user rights, interfaces, and process procedures regularly lead to new requirements and scenarios, which may not have been covered or sufficiently considered during the development phase. Processes must be modified, and configurations must be reconsidered.

The organization running the system is generally responsible for its operation and for ensuring compliance. The main responsibilities of the organization running a system include communication with the users and potential key or power users, providing support to the corresponding user groups and passing on queries as part of global business support. To register queries, to forward them and process them, a company-specific tracking or ticket system is required which also permits extensive evaluation.

Our experience in this field allows us to quickly categorize questions, to introduce corresponding processes if necessary, and to send the user a satisfactory answer as quickly as possible. This area also includes so-called incident and bug handling, which requires quick and effective processing when things get serious and represents an important part of the services we provide.

The subjects that arise during business support often lead to modifications and optimization of processes and of the system itself. Users can also notify the organization running the system of their own ideas and supply requests for changes, to suggest measures which would increase efficiency. Demand management involves pre-filtering the corresponding optimization options, to filter out the practical suggestions and to prevent an excess of change requests and associated work.

Pre-filtered suggestions (demands) are discussed together with the corresponding Process Owner, IT and other related departments. If necessary, Demands will be processed, prioritized and organized as part of the release management, which summarizes all changes into packages for system implementation, including validation activities. Such changes inevitably lead to modifications to the training material, which needs to be updated as required, and can lead to mandatory retraining of users.

Our experts have many years of experience in this field and can make use of a wide spectrum of technical knowledge, permitting practical demand planning and controlled releases of your application.

Managing projects competently and intelligently is our passion. Our project leaders combine extensive compliance expertise with high‐class project and change management. This allows us to create intelligent success through processes and solutions that are quickly adopted by the organization and that efficiently guarantee the fulfillment of the legal framework requirements. Our experienced staff support tasks such as Software Implementation, GxP Process Adaptation, CAPA Management, Complaint Handling, Change Control and Document Control.

Different operational models are possible, e.g. managed services which can be adapted to your specific needs.

CSV (Computer System Validation) is the process of ensuring that any technology component (software or hardware) is fulfilling its purpose in line with the regulatory guidelines for the particular industry. It is especially crucial in FDA-regulated industries like biotech and pharma since products from these sectors impact public health and safety. It’s essential to maintain quality standards in pharma since non-conformance can have far-reaching consequences.

Computer system validation checks the effectiveness and the efficiency with which the system is meeting the purpose for which it was designed. At Zamann Pharma Support, we can assist you in setting up a CSV schedule within your company, as well as all your other validation and qualification needs. Get in touch with us to discuss your requirements and queries today!

For the production of safe medical devices, pharmaceuticals or biotherapeutics, manufacturing environment conditions are of paramount importance. By controlling and monitoring the manufacturing environment, potential bioburden contamination can be limited, helping to ensure a high sterility assurance level for finished products. Zamann Pharma Support has experience in working with manufacturers to develop and implement effective environmental monitoring processes and their corresponding software packages.

Experience Innovation Success

Our experts and consultants provide a wide synergetic range of services which enables our teams to fulfill our customers' requirements in a fast and efficient fashion. Zamann Pharma Support provides the life science focus project management, and also a wide range of outsourcing activities and business support services.

Who are we?

Our employees have a diverse background and corresponding practical experience focused on the life science industry. Our people are our most important asset, and fully leveraging their potential is critical to our success. We want our employees to feel proud of their work and the company they work for. We motivate our employees through strong leadership, individual development opportunities, and rewards based on achievement.

Alireza Zarei

Managing Director

Marco Klinger

Quality Manager

Candice Quinn Birch

Business Improvement Manager

Elena Kaufmann

Quality Manager

Nouredin Soumeh

Head Medical Devices

Milad Zarei

Medical Device Officer

Kim Simon

Quality Manager

Reza Esmailie Soumeeh

IT Process Expert

Saeid Sadeghi

IT Group Lead

Simone Schmidt

Administration and Logistics

Our Customer Stories

Specialized professional competence in the area of software (biotech production) was very helpful for our project. We would be very happy to work with Zamann Pharma Support again in case we require consultancy.

The consultants are very professional. They take their roles and responsibilities very seriously. Normally I don’t give any perfect scores as a matter of principle, but Marco gets a “10” from me. Excellent work!

As always a very dedicated support throughout the year. Our ZPS support was instrumental in the development stream and thanks to their dedication and passion, we achieved all of our goals.

Excellent project manager and very capable. If you let an ZPS employee fill in space, they will doing it, never hesitating to drive and step to the plate. Extremely valuable. They go the extra mile with one idea in mind: make sure the project progresses!

Vision and Mission

A culture focused on innovation, trust and teamwork enable Zamann Pharma Support to flourish in the life science sector through excellent project efficiency and strong partnerships. Our open communication and results-driven approach, foster an enthusiastic, stimulating environment for both employees and company development.

Innovation

We challenge assumptions and conventional knowledge and consider the opportunities in every situation. We provide the time and freedom to nnovate.

Results Driven

We set clear, ambitious objectives – aligned to the company strategy – to deliver high performance and seek and rely on data to make decisions. We aim to be consistent and clear in decision making and focus our drive on simple, practical approaches.

Trust and Teamwork

We know that all people make all the difference and Trust and Teamwork is fundamental to our work. We engage fully and positively with colleagues through sharing ideas and responsibilities, and we maximize our experience and skills - because working together yields greater results.

Open Communication

To advance our projects rapidly, we need to make sound decisions based on facts. We listen to and inquire about others’ opinions, advice, and experience. This ensures efficiency and effective use of our resources.