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.
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.
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.