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.
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.