A multinational pharmaceutical and healthcare company
Ensure complaints related to pharmaceutical products coming from end clients (pharmacies, pharmaceutical wholesalers) are handled in compliance with legal regulations.
How we helped
- Organized a workshop with the client.
- Prepared a detailed process map.
- Designed the system.
- Developed the system.
- Tested the system and deployed it on the client’s premises.
- Integrated the system with the client’s SAP to ensure smooth data flow.
- Integrated the system with Kamsoft software used by pharmacies in Poland allowing them to send complaints directly.
- Ensured the system is compliant with GAMP 5 requirements related to the validation of IT systems working in the area of pharmaceutical manufacturing.
- Supported the client during inspections performed by the Polish Chief Pharmaceutical Inspectorate.
- Provided technical support and further development to ensure the system is compliant with legal regulations.
- Ensured compliance with the pharmaceutical regulations: complaint management process is regularly audited by the Polish Chief Pharmaceutical Inspectorate and all audits are positive.
- Ensured compliance with GAMP 5 regulations: the system achieves the desired, positive results in an accurate, consistent, and repeatable manner, which was documented during the validation process.
- Streamlined the process: complaints are handled fast, with due diligence, and while keeping in touch with end clients (pharmacies, pharmaceutical wholesalers).
- Met critical SLA requirements: technical support is provided quickly to solve any potential issues as soon as possible.