Project Management and Lead Consulting
Based on a jointly developed project understanding, we accompany customers in the planning, implementation and monitoring of project-related tasks. Our focus is on the diverse relationships between the various stakeholders, including users, departmental and system managers and their respective motivations, challenges and goals. All important processes and achieved results are visualized and communicated in a modern and target group-oriented manner. We see ourselves as consultants and solution finders at eye level - not as one-size-fits-all consultants. We lead projects result-oriented in the sense of our mandate with the attitude not to make a mountain out of a molehill. We master the art of what is feasible within the framework of what makes economic sense.
Process Optimization and Automation
It always is a good idea to rethink processes, regardless of whether an existing system is to be replaced or whether it is a matter of digitizing processes that have so far been predominantly paper-based and managed manually. What has grown over the years requires a critical reflection.
Reliable migration services are important. The implementation project often involves the import of existing data from previous systems to DHC VISION. During operation, they are needed for upgrades to higher releases of DHC VISION.
Migration of inventory data
If data from original third-party systems needs to be transferred once or cyclically, our proven methodology and associated services can help. Tools we have developed ourselves are specifically designed to meet the requirements of the regulated environment and DHC VISION. They ensure the smooth import of data. We carry out migrations in a comprehensible and fully documented manner. We are familiar with the special requirements in the validated environment. Our expertise and tools have been developed in over 100 migration projects. We import documents, guidelines and annexes, histories, trainings, risks, standards, non-conformities, CAPAs or other data including metadata.
First, our specialists analyze the data as part of a screening process. Together with the customer, we then determine the concrete migration procedure and methodology. The result is a detailed specification including a risk analysis and a concrete effort calculation for the implementation of the migration. We carry out the data migration (import), but also optionally take over the preparation, standardization or mapping of attributes and metadata of the data to be imported. Checks for linguistic correctness or completeness of metadata round off our service portfolio.
Migration to higher DHC VISION Releases
We provide our customers with new software versions as part of a maintenance agreement. We implement upgrades or updates for our customers, depending on the usage or operating model, if corresponding agreements exist for "Managed Services". This ensures that the software is always up to date.
The DHC VISION Integration Framework is the central point for the interaction of DHC VISION with other systems (e.g. ERP system) or for the connection to central user administrations (AD). We design specific use cases, subject them to professional and technical evaluation, and analyze the special requirements of integrated processes. On this basis, we then develop the appropriate interfaces.
Integrating DHC VISION with other application systems results in a variety of potential benefits and synergies: The compliance level can be improved; processes for compliance with regulations can be designed more efficiently; holistic processes in integrated systems can be realized.
Exemplary and already implemented closed loop scenarios:
Digital GMP manufacturing documentation - Simple and seamless creation of master batch records through to preparation for production
In DHC VISION, batch records, test specifications, test reports and packaging specifications are managed completely digitally and GMP-compliant; some are generated automatically. All production documents released during the day (delta comparison) are exported via night-time processing and made available to production in accordance with regulatory requirements. Batch numbers are simultaneously printed from the ERP system into the corresponding documents. DHC VISION Smart Document Logistic ensures that the currently released manufacturing specification is always supplemented with the relevant production/batch data and used in production.
The cross-system process for the comprehensible compilation/administration of manufacturing documentation or regulations for drugs is significantly accelerated; process risks are reduced to a minimum.
Cross-company standards management - Automated provision of current standards, regulations and documents for suppliers, service providers and customers.
In DHC VISION, the specification documentation is created easily. It is reliably checked, comprehensibly approved as well as released and distributed to the appropriate target groups. DHC VISION can be used as a cross-organizational QMS, so regulations are not only communicated internally, but also made available externally to suppliers, customers or partners. Suppliers or service providers have daily access to a portal with all valid regulations or works standards. Agreements or contracts with service providers are managed in a seamless and traceable manner, linked to the respectively valid works standards, for example.
Controlled and traceable management and distribution of service specifications for purchasing - extension of an IMS along the supply chain
Modern quality and compliance management systems no longer only encompass the internal world but the entire corporate network. Thus, framework contract partners or potential suppliers are increasingly being included in the system, either actively as authors/editors or passively as consumers. In this scenario, Purchasing uses standardized procedures and DMS functions from DHC VISION to version the bills of quantities created according to GEAB regulations, merge them with other documentation and distribute them to the appropriate target groups. The entire LV life cycle through to distribution is simple and completely traceable. The service specifications are provided automatically, by night run. New or updated bills of quantities are exported to a "supplier portal" so that framework agreement partners can download the current daily bills of quantities.
In the energy sector, for example, municipal utilities and other stakeholders have temporary access to documentation consisting of MS Office, PDF and/or GEAB files.
SAP/ERP interface for exchange, evaluation and generation of master data
In the controlled processes of an integrated QMS – e.g. CAPA management, deviation management, change or audit management, but also SOP management – access to master data such as CHARGES and MATERIALS is essential. Typical attributes/properties include batch number, material number, production date, expiration date/MHD, batch size, CE date, material type, material name, material number, material status or dosage forms. This information is usually stored in ERP systems. DHC VISION therefore has an interface for transferring data from SAP ERP to DHC VISION periodically, typically on a daily basis. Alternatively, a delta import or full import can be realized. Primary keys are used to identify the changes, which are aimed at a unique and stable characteristic over time (e.g. material number).
If you leave the world of lists behind you and start asking for meaningful key figures, we will be happy to accompany you in this exciting and directly economically effective field. For the individual DHC VISION solutions, such as SOP, Audit, CAPA, we supply prepared DHC VISION Data Marts. These provide the data section for the respective domain via standard interfaces. Our data marts can thus be connected to BI systems common in the industry; they fit seamlessly into existing Business Analytics Eco systems. Our services go far beyond simple data compression and the calculation of KPIs; we also act as a sparring partner for management and department heads. In dialogue with them, we develop relevant questions such as "what has happened and why?" and we design appropriate, target group-specific visualizations. This helps developing answers to the questions "What will happen next" and "What should I do now?”.
Training and Performance Services
Developing and implementing a suitable solution is one thing; training employees in their different roles is yet another. Only if these two aspects are correctly coordinated, a "perfect match" results. For this reason, we create customer-specific learning and training concepts and training documents that are specifically geared to different target groups. Since we don't know better what the users in a company need, we offer "user clinics" and work out the specific training requirements with our customers. We always work customer-centered! This is also reflected in the concrete training units, which we design in a target-group-oriented way and carry out with a role-based focus. We achieve sustainable training success via "quick guides" to the respective solution: "step by step" instructions guide users through selected processes in the software. Our customers decide whether multimedia technologies should be used or whether detailed process descriptions with screenshots from the respective solution are more appropriate. We can do both.
Learn once and then apply - this is how traditional training concepts are designed. The reality, however, is somewhat different: What is learned in training is quickly forgotten again; the transfer into the application is complicated. On the other hand, we rely on continuous support for users when working with the software - even after initial training. "Quick Guides" provide support as needed; small "micro-learning" units illustrate processes and interactions with the software. Process- and workplace-integrated information units accompany the user and provide valuable "performance support". Our "Content Services" offer advice on the design of a holistic training concept and, if required, also the (multimedia) implementation.
A holistic training concept is much more than just product training. It is based on a clear definition of target groups and roles; it focuses on the domain and raises awareness of technical aspects. It is also geared towards acceptance of the new solution by establishing a clear relationship between the digital solution on the one hand and corporate goals on the other, thus making the goals of the implementation project clear. Without staff understanding of what a digital solution is designed to achieve, any attempt at purely functional training will have no significant outcome. That's why we don't just pull out a ready-made training concept; we develop it together with our clients - in the interest of efficiency in implementation, effectiveness in results, and sustainability in application.
After Go-Live Services and Hyper Care
During the implementation project, the entire project team focused on one main objective: The go-live date. However, the go-live date is only one important milestone for the success of a software implementation project among others. It is also important to look at the subsequent phase: Although training can reduce many acceptance risks and usage problems, additional reinforcement is often required even after a solution has been put into operation. Experience shows: Immediately after the go-live date and with the transfer of responsibility from the project team to the support organization, the vast majority of problems reported to support are due more to a lack of understanding in working with the system than to a technical problem with the software. The commissioning should therefore be followed by a so-called "hyper care" phase, in which users are accompanied and additional support and assistance is provided in the specific work context. In such cases, we deploy employees from the core project team for this "hyper care" phase. They know the project and the developed solution best; and they are able to answer process- and system-related questions quickly and competently.