Building a system to manage complaints related to pharmaceutical products

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

Interested to see how a similar project might look in your company?

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Book a free 15-minute discovery call

Looking for support with your IT project?
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The controllers of the personal data are companies of FABRITY Group (hereinafter referred to as “Fabrity”) with its mother company Fabrity SA seated in Warsaw, Poland, National Court Register number 0000059690; the data is processed for the purpose of marketing Fabrity’s products or services; the legal basis for processing is the controller's legitimate interest. Individuals whose data is processed have the following rights: access to the content of your data and the right to rectification, erasure, restriction of processing, the right to object if the processing of personal data is based on consent and the right to data portability. You also have a right to lodge a complaint with PUODO. Personal data in this form will be processed according to our privacy policy.

Interested to see how a similar project might look in your company?
Contact us at sales@fabrity.pl to see how we can help.

Book a free 15-minute discovery call

Looking for support with your IT project?

Let’s talk to see how we can help.

The controllers of the personal data are companies of FABRITY Group (hereinafter referred to as “Fabrity”) with its mother company Fabrity SA seated in Warsaw, Poland, National Court Register number 0000059690; the data is processed for the purpose of marketing Fabrity’s products or services; the legal basis for processing is the controller's legitimate interest. Individuals whose data is processed have the following rights: access to the content of your data and the right to rectification, erasure, restriction of processing, the right to object if the processing of personal data is based on consent and the right to data portability. You also have a right to lodge a complaint with PUODO. Personal data in this form will be processed according to our privacy policy.

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