Short description:

The client, a pharmaceutical company, is introducing an ALM tool with the support of PTA. This tool is to support a number of processes in the future. Within the scope of the current project, the CSV process is to be implemented and validated in the ALM tool first.

Supplement:

PTA supports the customer in conducting the workshops for eliciting the requirements, implementing these requirements in the ALM tool, testing, documentation and final validation. In order to ensure a transfer to the operational business, PTA also supports the creation of training documents and accompanying training measures.

Technical description:

The CSV (Computerized System Validation) process has so far been paper-based. The maintenance of these documents and in particular the traceability of requirements, risks, technical specifications, test cases and test results requires a great deal of manual effort, and the manual maintenance of data is also prone to errors. The above-mentioned data and their traceability should therefore be maintained in an ALM tool in the future and gradually replace the paper-based process.