Computer system validation of a document management system

A newly introduced document management system (DMS) is based on a cloud solution provided by the manufacturer. The DMS is highly configurable (e.g. authorizations, workflows, document types, fields) and should be checked according to the rules of a standard software validation. For this purpose, the user requirements are derived from the existing Standard Operating Procedures (SOPs) and compared with the existing configuration. In parallel, a validation plan and the corresponding test cases are created in the ALM tool. Once the plan has been released and the traceability matrix has been created, the test cases are executed; any deviations are documented. Measures and priorities are subsequently defined within the corresponding business unit. After the validation report has been prepared in accordance with the SOP Computer System Validation, responsibilities are checked and defined and work instructions are revised and put into productive operation.