Standardized and flexibly scalable services for validation
Our products are designed to meet the requirements of highly regulated industries both in terms of technology and professionally. Our software complies with 21 CFR Part 11, among others. For validation, we offer comprehensive validation documentation including associated services. As a result, your system is validated with the least possible expenditure. These and other CSV services are based on more than 20 years of experience and excellent knowledge in validation and qualification of various, mainly complex computer systems.
Prospective validation of DHC VISION
We accompany the implementation of DHC VISION as well as the prospective validation with our tried and tested Validation Services. Validation is always carried out in accordance with the standard specifications of our customers. Relevant documents are prepared by us and in coordination with the customer. The expenditure for validation on the customer side is therefore reduced to a minimum. We achieve an additional reduction in effort through our so-called validation accelerators. These are a completely prefabricated set of validation documentation, which only needs to be adapted to the company’s individual situation.
Our approach and methods for validation and qualification of DHC VISION or generally computer-based systems always consider relevant guidelines or laws as well as known ISO standards. Examples include: EU – GMP (EMEA), 21 CFR Part 11 (FDA), 21 CFR Part 820 (FDA), ICH, GAMP, PICs, the law on medical products (Medizinproduktegesetz, MPG), the regulation on medical products (Medizinprodukteverordnung, MPV), 13485, 9001, 17779, 14791.
Complete offer for GxP compliance
Numerous myths surround validation, especially when, once again, a violation of GxP guidelines and FDA guidelines could be avoided at the last minute and with the last ounce of strength. The expenses for this have risen exorbitantly in recent years, both through the use of internal employees and, in addition, through the use of temporary external specialists. In the process, the focus of tasks is increasingly shifting to the arduous task of maintaining operational capability. There is hardly any time left for strategic considerations to optimize validation processes. As a result, there is often also an overfulfillment of the regulatory obligation. A closer look reveals a large number of optimization potentials with regard to costs, primarily through changes in the validation concept and through consistent standardization. Our goal is the sustainable reduction of your validation efforts and not the maximization of external validation days. That is why we only use experienced validation experts: Employees who generate added value with profound knowledge and demonstrate new solution paths and are not first trained at the customer.
Our full range of CSV services includes professional services for
- strategic planning,
- methodological conception,
- operational implementation of the validation as well as for
- permanent safeguarding and preservation of the valid state of computer-based systems.
The service offering consists of standardized “Consulting Packages” predefined in their respective scope of services. At the same time, these are comprised of flexibly scalable services for the implementation of CSV projects and for needs-based support in validation projects or audits. The focus is always on efficiency in implementation and the sustainability of achieved results.
Validation services at a glance
DHC VISION Validation Accelerators and Package
The DHC VISION software is well prepared for use in highly regulated (e.g. GxP / FDA regulated) industries. In doing so, we do not start from scratch and create time-consuming comprehensive validation documents and SOPs, but use a variety of field-tested templates. The resulting productivity gains benefit the customers in full.
For the validated implementation of DHC VISION we offer a completely prefabricated set of validation documentation, which only needs to be adapted to the individual situation of the company. The so-called “Validation Accelerators” are validation-relevant templates and process models for all stages of validation – from the validation plan to the Part 11 analysis, the specification of user requirements (URS) and the test case definition to the final validation report. These accelerate the validated implementation of DHC VISION, reduce the validation expenditure and ensure compliance conformity to a considerable extent.
As a Validation Package, we accompany the system introduction as well as the prospective validation with our proven Validation Services. These serve to further minimize the validation expenditure for DHC VISION and preparation of all documents in coordination with the customer. Aligned with our customers’ standard specifications, our methodology combines process and requirements specification with corresponding verification and testing. Project and product-specific risks are taken into account.
The validation of DHC VISION can therefore be carried out by our experts in parallel with the implementation. A validated system is available upon project completion.
Managed Validation Services and VxP | Validation Platform
With out Managed Validation Services (MVS) we offer all organizational and technical measures required to permanently ensure the valid state. The MVS are used for the continuous validation of your DHC VISION system or to maintain the valid state after GoLive in case of changes, deviations, the installation of hotfixes and patches or in case of planned updates or upgrades.
The cloud-based VxP Validation Platform is used to map this process completely digitally. It is used to digitize validation documentation and automate validation processes. At the same time it serves as a collaboration platform for all validation activities around DHC VISION. Functionally, VxP includes a compliant DMS for purely electronic management of validation documentation. In order to keep valid operations and documentation up to date in the event of changes and deviations, the VxP also has the necessary workflows and procedures for the controlled management of CAPAs, changes and deviations. You can find all important details regarding VxP here.
CSV Planning and Concept
A Compliance Check assesses the compliance status of IT systems and identifies existing gaps. DHC is developing a roadmap and business case for CSV with implementation recommendations.
We check the compliance status of selected systems in a Friendly Audit. The basis is the system documentation and a high-level self-evaluation. An audit report identifies recommended actions and strategic options.
CSV Implementation and Support
The IT Compliance Packagereviews the current state of CSV practice and strategy in the organization. The basic features of a validation and compliance strategy are derived from this. DHC develops applicable validation methods and tools.
The DHC Validation Services offer support through staff coaching are directed towards the actual validation of IT systems. Validation is carried out efficiently according to “best practice” and is risk-based.
The Validation Cloud-Based System takes a look at the special features of cloud solutions. It reviews and defines the framework for standards-compliant software use in the cloud.
CSV Sourcing is the solution for competent staffing of validation projects. CSV Sourcing takes into account different roles and delivers the experts needed in the project. DHC supports validation projects of shorter or longer duration.
Our other services
Consultation and solution-finding at eye level
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.