We analyse the GxP requirements that are relevant for you and make pragmatic recommendations for actions to take on the basis of risk analyses. DHC’s work in this area is not only characterised by our excellent computer system competencies but in particular by our know-how in project and process management, as well as long-standing industry experience in life sciences (particularly pharmaceuticals) and medical technology.
DHC offers a uniform, methodical, process-oriented and risk-based approach to validation. We orient ourselves here on the V-Model according to the latest version of GAMP, the ISO standards, and the requirements of the FDA (especially 21 CFR Part 11) and European regulators (especially EU GMP Guide Annex 11). Our approach is tailored to the needs of our customers, and meets all of the criteria for a cost- and benefit-optimised methodology. We can also handle projects requiring integration with an existing Quality Management system.
The portfolio of CSV services offered by DHC is based on a maturity model for the validation of computer systems. Services are offered for the support of strategic planning and conceptual method design, for the professional execution of software validation, and for the long-term assurance of the valid state of relevant computer systems.
Services are offered as a standardised ‘consulting package’ that is predefined in terms of its service scope: the package also includes services that can be scaled flexibly in order to complete validation projects or offer on-demand support as needed for company-internal validation projects. Priority is given here to ensuring efficient execution and the sustainability of the results achieved.