
idsTrust (CEO Jeong Gil-ho) said that Daewoong Pharmaceutical's Osong factory, which applied the company's 'GMP-specialized IT solution', received 'no observations' (Zero Observation) in the quality management standard (GMP) inspection by the Brazilian Food and Drug Surveillance Agency (ANVISA). It was announced on the 9th that the results were notified.
It is known that Brazil's Anvisa inspection team selected Daewoong Pharmaceutical's Osong factory's 'paperless factory' concept as a strength. idsTrust's electronic document management system (EDMS), which is currently applied to the Osong plant, integrates and manages various and complex GxP documents specialized for paperless throughout the entire cycle.
Through this, paper document management problems were resolved and data integrity was secured through a document access audit trail, thereby simplifying due diligence response.
During this due diligence process, the ‘Data Integrity’ management ability of Daewoong Pharmaceutical’s Osong plant, which operates based on idsTrust’s IT solution, was highly evaluated.
In particular, the company believes that having an IT system that cannot manipulate process records has had a positive impact. Since the pharmaceutical industry is directly related to human life and health, IT solutions that can prevent artificial errors are evaluated as essential, not optional.
Seungha Lee, Center Director of Daewoong Pharmaceutical's Osong Plant, emphasized, "idsTrust has created a specialized solution with an accurate understanding of the pharmaceutical industry," and added, "In fact, other companies have also adopted and are operating idsTrust's factory IT system."
An idsTrust official said, “We are happy that the Osong factory passed the An-Visa GMP inspection without any complaints using idsTrust’s factory IT solution.” He added, “We will not rest on our laurels, but will further develop our IT solution to encompass the entire healthcare field.” “We will expand the solution,” he said.
idsTrust has been recognized for its competitiveness through its own research and development of IT solutions based on its understanding of pharmaceutical domain knowledge.
It is designed to be organically linked with enterprise resource planning (ERP), making it easy to manage the entire process in an integrated manner. Currently, there are 24 factories using idsTrust’s IT solutions.
Here, idsTrust recently launched the Learning Management System (LMS) and completed the quality management package of Electronic Document Management System (EDMS), Laboratory Information Management System (LIMS), Quality Management System (QMS), and Learning Management System (LMS). did.
Source: Pharmacy Newspaper