There are many myths about Computer Software Validation (CSV), especially when it comes to last minute activities and urgent efforts to avoid conflicts with GxP and FDA regulations. In addition, costs associated with CSV have increased significantly over the past years, regardless of whether in-house staff performs validation tasks or whether external experts become involved in validation projects on a temporary basis. In either case, the focus primarily is on maintaining operating capabilities. Generally, there is not much room for strategic considerations; companies very often lose sight of their need to optimize existing validation processes.

And yet, on closer inspection there are many ways of reducing validation costs. Modifying existing approaches to CSV and standardizing validation methods are but a few options to take into consideration.

This is what drives us at DHC: We are concerned with reducing your validation costs – rather than increasing the number of consultancy days we spend on validating your computer software systems. We staff projects with experienced validation experts, not with junior consultants who receive their initial training on your limited validation budgets. Our expert validation services, thus, generate value and open new paths to effective CSV.

DHC’s validation services follow a “maturity model” for CSV. Services range from strategic planning support and methods development to validation implementation and measures to maintain and secure a system’s validated state. DHC’s service portfolio allows for targeted interventions at any stage of the validation life cycle; it accounts for different degrees of maturity in computerized systems validation.

DHC offers standardized consulting packages with a pre-defined scope of activities. The portfolio also includes flexible and scalable validation and validation support services. Our main concern is efficient project implementation and sustainable project results.

Our process and methodology for validation and qualification of (computer-based) systems, processes, devices or medical products take into account relevant guidelines such as EU - GMP (EMEA), 21 CFR Part 11 (FDA), 21 CFR Part 820 (FDA), ICH, GAMP, PICs and laws like the German Medizinproduktegesetz (MPG) or the Medizinprodukteverordnung (MPV) or the equivalent ISO norms like for example 13485, 9001, 17779, 14791.

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