Infamed K reduced material costs of working with GxP documentation by 10% thanks to Directum RX

2022:10% reduction in material costs for GxP documentation

Thanks to the transition to Directum RX, Infamed K reduced the volume of paper documents, accelerated work with GxP documentation, and reduced material costs for these processes by 10%. This was announced on September 2, 2022 by Directum.

Miramistin, the developer and manufacturer of the medicinal product, has converted business processes related to compliance with the requirements of the Pharmaceutical Quality System (FSC) and GMP standard using Directum RX into electronic form:

Control and execution of GxP documentation. To create GxP documents, templates are used that are easy to keep up-to-date without the help of developers. The approval takes place in electronic form along a pre-configured route, which ensures the traceability of the approval stages, information on the plans-schedules for the development of documentation is stored in a special register. The system provides automatic coding and monitoring of the development and updating of documents.

CAPA Plan Management. Users' access to CAPA plans is delimited according to their authority. All CAPA information is stored in the system, you cannot lose important information. Information about all CAPA-plan documents shall be entered into the register indicating the developer and his subdivision. The registry has the ability to track the progress of the plan, which helps to increase the transparency of working with CAPA.

Change control. Procedures have been developed for coordination and assessment of the impact of changes, reports on their implementation, etc. Information about all initiated changes in the company is entered in a special register of change sheets. Infamed K strives for import independence, IT infrastructures so the system is deployed on, and a DBMS Postgres Pro package is used to edit documents. OnlyOffice The digitalization project was implemented jointly with the company "."Akelon

The introduction of digital tools to optimize business processes in accordance with international GMP standards gives us a significant plus and increases the manageability of the quality system. This primarily affects the reduction of the influence of the human factor: people make fewer mistakes, deadlines and regulations are observed, the risks of non-compliance are reduced, said Alla Borovik, Deputy Quality Director of Infamed K.