Building a document management system to ensure compliance with GMP standards in a pharmaceutical factory

Client

A leading OTC manufacturer

Industry

Life science

Business goal

Ensure compliance with Good Manufacturing Practices (GMP) by providing up-to-date procedures for every employee involved in the production process.

How we helped

  • Built standard and custom document management workflows.
  • Built the digital document repository and archive.
  • Automated the process of creating, reviewing, and accepting documents related to GMP standards in the pharmaceutical factory.
  • Created an audit feature making it possible to check the correctness of created documents.
  • Created a testing feature to check if employees know the most up-to-date documents and instructions.
  • Built a feature making it possible to track down all paper copies of the documents.
  • Added a feature allowing for group work on documents.
  • Integrated with Office Web Apps and Active Directory.
  • Provided maintenance and further development.

Business outcome

  • Ensured GMP compliance: the quality control department can easily ensure and monitor compliance of the workplace instructions with good manufacturing practices.
  • Ensured high quality: every employee always has up-to-date workplace instructions.
  • Streamlined the process: the document management process is now highly automated.
  • Reduced error risk: advanced mechanisms ensure that documents are correct and have been reviewed and accepted.

Technology stack

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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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