Case Study: Successful validation of processes in the pharmaceutical industry with SAP HANA

The IT company SINOVO supports a leading pharmaceutical company in validating relevant processes for Good Distribution Practice (GDP) in SAP HANA - focussing on quality and safety.

SINOVO business solutions GmbH successfully carried out the Computer System Validation (CSV) of the ERP system (Enterprise Resource Planning system) of a multinational pharmaceutical company within the time frame requested by the customer. As part of the customer's SAP HANA conversion, the GDP-relevant processes (Good Distribution Practice) mapped in the software, such as ‘goods release’ and ‘customer release’, were validated.

Computer system validation is the systematic verification that a computer system works reliably and securely and that it continuously fulfils the functions expected by the customer.

The project contributes significantly to compliance with legal requirements and to ensuring product quality.

Validation of pharmaceutical processes: Challenges and goals

One of SINOVO's customers, a pharmaceutical company and leading manufacturer of hyaluronic acid, needed to validate their critical software processes in their ERP system (SAP HANA). This was realised with a computer software validation. The focus was on the management of goods in the external warehouse and the legally compliant processing of pharmaceutical sales. In addition to the documentation and risk analysis, SINOVO carried out comprehensive tests to ensure the functionality and security of the processes. Here you can find more information about the software testing: Computer System Validation for Compliance & Quality.

Convincing solutions for validation

SINOVO realised the following solutions for validation as part of the project:

• Process analysis and visualisation: flowcharts for process transparency.
• Risk assessment: Identification and minimisation of potential weak points.
• Comprehensive tests: definition, implementation and evaluation of manual test cases.

Conclusion: Quality as the basis for trust in pharmacy

‘With the successful validation, we have made a decisive contribution to optimising the supply chain in the pharmaceutical industry for our customer, which makes us very happy for them,’ says Jan Filip, Managing Director of SINOVO business solutions GmbH. The project not only strengthens legal compliance, but also confidence in the pharmaceutical company's products worldwide.

SINOVO  Group

SINOVO has been offering corporate customers customised software development, IT infrastructure design including IT security, development of digital health applications (DiGA), quality management services and software testing across all industries for 25 years. With our ISO 13485 and ISO 9001 certified quality management system, our ISO 27001 certification for information security management systems and our certification as a Microsoft partner, we ensure that our solutions meet your high quality standards.

Press contact

SINOVO business solutions GmbH, Tanja Schönfeld, Willy-Brandt-Str. 4, 61118 Bad Vilbel, Tel.: +49 6101 590 90 00, E-Mail: presse@sinovo.de , Web: sinovo.de