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.