Consultation and solution-finding at eye level
The digitization of quality and compliance processes, taking into account all conceivable “side effects”, requires the use of professionals with professional and industry experience in the project team. Our experts therefore support you with full commitment not only during but also before implementation. Your goal: To realize the system perfectly tailored to your requirements and objectives. Meaningful in terms of budget, time, scope, and quality.
Based on the jointly developed understanding of the project, we accompany customers in the planning, implementation and monitoring of project-related tasks. Our focus is on the various relationships between the different stakeholders, including users, business unit managers, system managers, and their respective motivations, challenges, and goals. All important processes and the results achieved are visualized and communicated in a way that is appropriate to the time and the target group. We see ourselves as consultants and solution finders at eye level – not as one-size-fits-all consultants.
Professional Services at a glance
Project Management and Lead Consulting
We manage projects in a results-oriented manner in line with our mandate, with the attitude of not making a mountain out of every molehill. We have mastered the art of what is feasible within the framework of what makes economic sense.
Process Optimization and Automation
It is always advisable to rethink existing processes, regardless of whether an existing system is to be replaced or whether digitization of previously predominantly paper-based and manual procedures are involved. What has grown over the years requires critical reflection.
The implementation project often involves importing existing data from previous systems into DHC VISION. During operation it is needed for upgrades to higher releases of DHC VISION: Our reliable migration services. The expertise as well as tools have been developed in over 200 migration projects. We know the special requirements in the validated environment. Therefore, the tools we have developed ourselves are specifically designed to meet the requirements of the regulated environment and ensure the smooth import of data; traceable and fully documented.
Migration of existing data
We import documents, policies and attachments, histories, trainings, risks, standards, non-conformities, CAPAs or other data including metadata from third-party systems (one-time or cyclically). After an initial screening for data analysis, our specialists work with the customer to determine the specific procedure and methodology for migration. The result is a detailed specification including a risk analysis and a concrete cost calculation for implementing the migration. In addition to the migration, we can also take over the preparation, standardization or mapping of attributes of the data to be imported. Audits for linguistic correctness or completeness round off our service portfolio.
Migration to higher DHC VISION releases
We provide our customers with new software versions as part of the maintenance agreement. We implement upgrades or updates for our customers, depending on the usage or operating model, if corresponding “Managed Services” agreements are in place. In this way, the software always remains up to date.
If you leave the world of lists behind and start asking for meaningful key indicators, 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 deliver prepared DHC VISION data marts. These provide the data section for the respective domain via standard interfaces. Our data marts can therefore be connected to industry-standard BI systems and fit seamlessly into existing business analytics eco-systems. Going far beyond simple data aggregation and calculation of KPIs, we offer ourselves as sparring partners for management and department heads. In dialog with them, we work out the relevant questions “What happened and why?” and the appropriate, target group-oriented visualizations, and use them to approach the answers to the questions “What will happen next?” and “What should I do now?”.
The DHC VISION Integration Framework is the central point for the interaction of DHC VISION with other systems (e.g. ERP system) or for connecting to central user administrations (AD). We design specific use cases, subject them to a functional and technical evaluation and analyze the special requirements for integrated processes. We then develop the appropriate interfaces on this basis.
When DHC VISION is integrated with other application systems, there are many 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 up to provision for Production
In DHC VISION, manufacturing instructions, test specifications, test protocols and packaging instructions are managed completely digitally and GMP-compliant; generated partially automatically. Through night processing, all manufacturing documents released during the day (delta reconciliation) are exported and made available to production in compliance with regulatory requirements. Batch numbers are printed simultaneously from the ERP system to the associated documents. DHC VISION Smart Document Logistic ensures that the currently released master batch record is always supplemented with the relevant production/batch data and used in production.
The cross-system process for comprehensible compilation/management of manufacturing documentation or regulations for medicinal products 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 easily created, reliably checked, comprehensibly approved, accurately released, and distributed to the appropriate addressees. As a cross-organizational QMS, the regulations are not only communicated internally, but also made available externally, to suppliers, customers or partners. Suppliers or service providers have access to a portal with all valid regulations or, for example, factory standards, on a daily basis. Agreements or contracts with service providers are managed in such a way that they are fully traceable and linked to the applicable work standards, for example.
Controlled and traceable management and distribution of service specifications for Purchasing – Expansion of an IMS along the supply chain
Today, modern quality and compliance management systems encompass not only the internal world but the entire corporate network. Partners in the master agreement or potential suppliers are therefore also increasingly recorded by the system. Either actively as authors/editors or passively as consumers. In this scenario, the Purchasing department uses standardized procedures and DMS functions of DHC VISION to version the service specifications created according to the regulations of the GEAB, to merge them with the other documentation and to distribute them according to the target group. The entire LV life cycle up to Distribution is simple and completely traceable. The service specifications are provided automatically, by night run. New or updated service specifications are exported to a “supplier portal” so that partners in master agreements can download the latest service specifications on a daily basis.
In the energy sector, for example, municipal utilities and other stakeholders receive temporary access to documentation consisting of MS Office, PDF and/or GEAB files.
SAP/ERP interface for the exchange as well as the evaluation and generation of master data
In the controlled processes of an integrated QMS, such as CAPA management, deviation management, change or audit management, but also SOP management, access to master data such as BATCHES and MATERIALS is essential. Typical attributes / properties here include batch number, material number, manufacturing date, expiry date/best before date, batch size, PU date, material type, material name, material number, material status or the dosage forms. As a rule, this information is kept in ERP systems. DHC VISION therefore has an interface to periodically, typically daily, transfer the data from SAP ERP to DHC VISION. Alternatively, a delta import or full import can be realized. Primary keys are used to identify the changes, which target a unique characteristic that is stable over time (e.g. material number).
Training and Performance Services
Developing and implementing a suitable solution is one thing; training employees properly in their various roles is another. Only when these two aspects are properly coordinated is there a “perfect match”. Therefore, we create customized learning and training concepts and training materials specifically designed for different target groups. Since we don’t know any better what the users in a company need, we offer “User Clinics” and work out the specific training requirements in each case with our customers. We always focus on the customer! This is also reflected in the specific training units that we design for specific target groups and conduct based on roles. We achieve sustainable training success using “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 detailed process descriptions with screenshots from the respective solution are the right thing to do. We can do both. Learn once and then apply – this is how traditional training concepts like to be designed. But the reality is somewhat different: What is learned in training is quickly forgotten and transferring into application is complicated. On the other hand, we rely on continuous support for users working with the software – even after initial training. “Quick Guides” provide support as needed, small “microlearning” units illustrate processes and interactions; process- and workstation-integrated information units accompany the user and provide the “performance support” that is so valuable. Our “Content Services” offer consulting in 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 takes a look at the domain and raises awareness of professional aspects. It is also geared towards acceptance of the new solution by establishing a clear link between the digital solution and corporate goals and making the objectives of the project to introduce digital quality management clear. Without an understanding by employees of what they want to achieve with a digital solution, any attempt at purely functionally oriented training will remain without significant results. It is for this reason that we do not apply a prefabricated training concept. Instead, we develop it together with our customers 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 goal: The Go-Live. However, the go-live date is only one important milestone among many others for successful software implementation. It is also important to look at the phase afterwards: This is because although training can mitigate many acceptance risks and usage issues, additional reinforcement is often required even after a solution has gone live. This is what experience shows: Immediately after go-live and with the transfer of responsibility from the project team to the support organization, the vast majority of problems reported to Support are due to a lack of understanding of how to work with the system rather than a technical problem with the software. The commissioning phase should therefore be followed by a so-called “hyper care” phase, in which users are accompanied and receive additional support and supervision in the specific work context. In such cases, we assign staff from the core project team to 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.
Our other services
Standardized and flexibly scalable services for validation
Support is an elementary component of our understanding of service
Responsible handling of internal IT services
Our software as a full service cloud solution
Do you have any questions?
Do you have questions about our services or would you like more information? Then contact one of our experts directly. They will be happy to assist you at any time, answer any questions you may have about the service and product portfolio, and look forward to your inquiry.