By Ingalis A.G. (ed.)
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Why is this? We will look at ten critical success factors for reducing the time to validate a core system to around 3 months without compromising the quality of the system. This is achieved by managing regulatory risk effectively and resourcing the project adequately. Here, I would like to focus on what is needed to ensure a rapid validation of a CDS while maintaining the overall quality and managing regulatory risk. I’ll look at how CDS validation is typically conducted today, what we should aim to achieve in a rapid validation project and my ten critical success factors for such a project.
Chapters 8–23 in validating the system for intended use including ensuring that controls for electronic records integrity are enabled, documented and validated. ●● Chapter 24 ensuring that users are training both in the system and good data integrity practices. ●● Chapter 30: User account management to ensure the separation of administration accounts from user accounts to avoid potential conflicts of interest and ability to falsify data. ●● Chapter 33: Under the umbrella of a periodic review there will be data integrity audits of the system and the data generated.
5 P art 4: Risk, Traceability, Configuration, Installation and Integration The URS should be updated after system selection or if upgrading an existing CDS installation to document the features of the CDS to be installed in the laboratory. Chapters 16–20 cover the detail of carrying out a risk assessment on the requirements, the traceability matrix, documenting the IT system and the software configuration used and installation and integration of the delivered system with the chromatographs in the laboratory.