Software Validation
Software Validation
Software validation makes it possible to confirm, by way of testing and by providing objective evidence, that software specification is consistent with the user’s requirements and intended use and the implemented solution consistently satisfies predefined assumptions.
Software should be subjected to validation wherever it is used for supporting regulated processes and wherever it replaces manual operation.
Software must not cause any deterioration in product quality, limit process controls or quality assurance.
In the medical and pharmaceutical industries, software supports numerous manufacturing and business processes.
We do software validation regarding, among others:
ERP systems
Databases
LIMS, RMS, BMS, PCS, WMS, TMS
Cloud solutions (SaaS Solution)
GMP process supporting tools (testing, including test automation, change control processes, documentation management)
SCADA (RMS, BMS) systems
Sample Project
Subject
SAP System: SD
(Sales and Distribution)
SAP System: SCM
(Supply Chain Management)
SAP System: FICO
(Financial Accounting and Controlling)
Scope
The scope of SAP system support includes operations as well as project implementation.
The main task within the operations was to maintain the system in the validated state. The principal tool used to this end is the change control process, which guarantees that all the changes are properly evaluated, documented and tested prior to being implemented on the production server.
Last year we conducted about 3,000 change requests.
One of the projects conducted was validation as part of the SAP implementation at new sites.
An updated, validated solution was migrated, and additional modifications were performed. As a result of this process, several dozen User Requirement Specifications and more than a hundred functional and technical specifications were updated.
Several regression tests were performed with regard to the migrated solution, albeit in a limited scope. New modifications were fully tested (unit tests, system tests, user acceptance tests).
Results of implementation
The implementation was successful and the main SAP system was expanded by further 3 implementations.
The work was all conducted on the basis of a Validation Plan and a Risk Analysis conducted beforehand.
Finally, the work was summarised in the Validation Report.
