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IT validation of a SAP software interface


Non-sterile consumer health pharmaceutical plant


Montreal area (Quebec), Canada


Qualification and validation


As part of a central palletizing project in its plant, our client wanted to automate inventory transactions when new pallets of finished products were generated. Since product traceability and reconciliation must be ensured at all times, the software used to make inventory transactions had to be validated.


Genipro was mandated to write the computer system life cycle (CSV) documents (VP-URS-SDS-SAT-IOPQ), execute the qualification protocols and write the associated reports.


The main challenge in this mandate was to understand the internal workings of the software application custom designed for the client, as well as to map the data flow from the palletizer to the SAP ERP system. Subsequently, the writing of specification documents (URS, SDS) allowed us to identify and ask the integrator to implement several opportunities for improvement before validation in order to consider all the operating use cases and exceptions that would allow to ensure data integrity in all circumstances. The SAT was conducted test environment which allowed for rapid implementation in production, while the final validation protocols were executed and approved in less than a work shift. This speed of execution was crucial for our client since the palletizer processes all the products packaged in its plant. Our mastery of computer science and our 360 approach allowed us to successfully complete the validation with minimal negative impact on operations.
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