Client
A multinational pharmaceutical and healthcare company
Industry
Life science
Business goal
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.
Business outcome
- 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.
Technology stack
