Electronic drug licensing process. Implementation of the Good Manufacturing Practice Drug Licensing Process

Customer: Grindeks SIA

Sector: private

Challenges

Extremely strict document management standards are applicable in the pharmaceutical sector. Earlier "Grindeks" managed these processes mechanically, which consumed a lot of time and required a large number of employees. Perfect document management for medical drugs and their ingredients is a pre-condition for obtaining the Good Manufacturing Practice certificate, which is obligatory in the EU, USA and CIS countries in order to engage in the sales of medicines.

Solution

The solution implemented by "Grindeks" was developed by the Slovenian company Infotehna and specifically adapted for the pharmaceutical industry. UAB "ERP" was responsible for the management of the Project and quality control in compliance with the GMP standards. It is one of the best solutions in this field. The solution is distinguished for its particularly strict document management rules and enables Grindeks to manage documents and medicine registration in a centralised way and observe the evolution of information during the entire life-cycle.

The technological solution was based on the EMC Documentum platform and adapted for consistent work with EMC Captiva scanning software and later it was integrated with the eRoom software in order to improve communication inside the Company and carry our information exchange between its remote divisions.

The new system helps shorten the long period of time required to draft product documentation, reduce the risk factors related to the non-compliance with the quality standards and eliminate the possibility of human error.

The implemented electronic document management system My-Pharma was developed on the basis of the platform of EMC Documentum, which is one of the largest information management system developers in the world. The My-Pharma solution by the Slovenian "Infotehna" has been already installed in the major pharmaceutical companies such as Pliva, Ratiopharm and KRKA as well as in the manufacturing sector, namely, BMW, Volkswagen, Adidas, Sony and Philips, in the US airlines and other large companies.

During the implementation of the Project, the hardware and network structure necessary for the system were prepared, software was installed, and the platform and My-Pharma software were configured.

Results

The electronic document management process developed using EMC technologies in compliance with the standards applicable in the pharmaceutical industry.

Used software products

• EMC Documentum Content Server.
• My-Pharma.
• EMC Captiva.

Partner: Slovenian company "Infotehna".

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