Infotehna Group - Pharmaceutical Software Solutions White Papers

Efficient Drug Registration Process Based on Document Management In today’s extremely complicated regulatory environment, which is becoming even more complicated by the hour, it is no longer possible to meet challenges of tomorrow with yesterday’s tools. Mountains of paper, the brand of every regulatory affairs department for so long, are bound to disappear. In the new, mostly electronic environment, the quality of a software solution will increasingly become the comparative advantage on the drugs’ long journey from an idea to the market.
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EDMS Based Development Documentation: Decreased Time to Market Processes in pharmaceutical development departments are mostly serving drug development projects. Documents resulting from these processes normally describe the process milestones. By means of applying the right set of attributes to each document, project management and reporting could be made much easier and less time-consuming.
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EDMS Based QA/QC Documentation: the Lasting Answer to GxP Challenges In all GxP areas, document handling is one of the most exposed areas when it comes to regulatory inspections. While good document management system cannot by itself ensure the favourable result of an inspection, the lack of it is almost sure to ruin the company’s high expectations, even if there is nothing essentially wrong with the presented data. In order to deal with all the documentation pertinent to the challenges in GxP environment, INFOTEHNA developed QualityExpert. QualityExpert is the solution based on INFOTEHNA proprietary application myProcess, which ensures the compliance with all regulatory requirements, including 21CFR11. In addition, myProcess is the base for all other INFOTEHNA myPharmaExpert Suite solutions, which ensures 100% cross-solution compatibility.
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Efficient Pharmacovigilance Process Based on Document Management Each company has to establish a pharmacovigilance system, with the primary aim of ensuring timely gathering, analyzing and submission of safety concerns. This documentation is the primary target for any pharmacovigilance audit and thus has to be maintained in a way similar to GMP documentation. INFOTEHNA solution provides profiles for all of the necessary documents, with predetermined templates, lifecycles, workflows and roles.
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