SAP Consulting and Software Validation

Validation of IT-Systems

Validation of IT-Systems

Methodical, process-oriented and risk-based validation approach for software validation

Since 1996, we have been gaining experience in the prospective and retrospective validation of various complex computer systems, such as ERP systems, document management systems, clinical trial software, LIMS, etc. We analyze the GxP requirements that are relevant for you and pragmatically specify the measures you will need to take based on risk analyses. Here, DHC distinguishes itself not only with an excellent knowledge of IT systems, but also through expertise in project and process management as well as a deep industry experience in the life sciences (particularly pharmaceuticals and medical devices).

DHC provides a uniform, methodical, process-oriented and risk-based validation approach (DHC’s Simple Validation Services). We base this approach on the V-model from the latest version of GAMP, the ISO standards and FDA requirements (particularly 21 CFR Part 11) and the European authorities (in particular EU GMP Guide Annex 11). Our approach is tailored to the needs of our customers and meets all the criteria for optimal costs and benefits. We also allow for integration into an existing quality management system.

  • Knowledge of policies and long-term experience in the validation of various applications
  • Templates, SOPs to be able to perform an efficient validation
  • Assistance in designing and implementing a validation framework
  • Support in specific projects (validation management, operational support, coaching, …)
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