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Software Validation

Here we work together with a partner. Together we can offer the full range of the SW Validation (Software Validation). We can support you with the following tasks:

-      Preparation of the user requirement specification (URS)

-      Based on your needs the corresponding validation protocol

-      Support you with your risk analysis

-      We also can support you active with a wide variety of validation tasks (collaboration in validation projects, planning and moderation of workshops, prepare the test protocols as well as support you during the test, prepare and document go live simulation as well as the actual go live). 

-      Audits (System audits and analysis of critical points, audits at vendors and service providers). 

-      Expansion of quality system (write "Standard Operating Procedures" for computer validation and system operations).

It is important to understand who is responsible for what (software provider vs. customer) and define the corresponding responsibilities from the start. Additionally, it is crucial to understand when the guidelines start to be valid (eg change control).

If you do not feel confident we can support you together with our partner.