Prospective Validation of DHC VISION
We accompany the DHC VISION implementation as well as the prospective validation with our proven Validation Services. Validation is always carried out according to the standard specifications of our customers. Relevant documents are created by us and in coordination with the customer. The customer's validation effort is thus reduced to a minimum. We achieve an additional reduction in effort through our so-called Validation Accelerators. The accelerators are a completely prefabricated set of the validation documentation, which only has to be adapted to the individual situation of the company.
Our procedures and methods for the validation and qualification of DHC VISION or generally computer-based systems always take into account relevant guidelines or laws as well as known ISO standards. Examples are EU - GMP (EMEA), 21 CFR Part 11 (FDA), 21 CFR Part 820 (FDA), ICH, GAMP, PICs, the Medical Devices Act (MPG), the Medical Devices Ordinance (MPV), 13485, 9001, 17779, 14791.
Complete offer for GxP Compliance
Our entire CSV range of services includes professional services for
- stategic planning,
- methodical conception,
- operational implementation of the validation as well as
- for the permanent safeguarding and maintenance of the valid state of computer-aided systems.
The range of services consists of standardized "consulting packages" predefined in their respective scope of services. At the same time, it consists of flexibly scalable services for the implementation of CSV projects and for demand-oriented support in validation projects or audits. The focus here is always on efficiency in implementation and the sustainability of the results achieved.
DHC offers standardized, pre-defined "consulting packages" and flexibly scalable CSV services. The goal is efficient project implementation and sustainable results.
A compliance check evaluates the compliance status of IT systems and identifies existing gaps. DHC develops a roadmap and a business case for CSV with implementation recommendations.
DHC checks 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 shows recommendations for action and strategic Options.
The IT Compliance Package checks the current status of CSV practice and strategy in the company. The main 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 employee coaching aimed at the actual validation of IT systems. Validation is efficient, best practice and risk-based.
The validation of cloud-based systems focuses on the special features of cloud solutions. It checks and defines the framework for standard-compliant software use in the Cloud.
CSV Sourcing is the solution for competent staffing of validation projects. CSV Sourcing considers different roles and provides the experts needed in the project. DHC supports validation projects with short or long Duration.
DHC offers Managed Validation Services for all organizational and technical measures required to ensure IT compliance and CSV on a permanent basis. Service Level Agreement (SLA) defines the type and scope of CSV services as required.td>
Risk-balanced and cost-optimized to the goal of GxP compliance
There are numerous myths surrounding validation, especially when it was once again possible last minute and with the last effort to avoid violating the GxP guidelines and FDA guidelines. The costs involved have risen exorbitantly in recent years. Both through the use of internal staff and the addition of temporary external specialists. The focus of tasks is increasingly shifting to the laborious maintenance of operational capability. There is hardly any time left for strategic considerations to optimize the validation processes. As a result, the regulatory obligation is often overfulfilled.
A closer look reveals a multitude of optimization potentials with regard to costs. Above all 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. This is why we use only experienced validation experts. Employees who generate added value with profound knowledge and point out new solutions rather than being trained at the customer's site.
You can request a complete overview of our validation expertise, a whitepaper on validation or a non-binding offer here.