Blulink - Pharma

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Pharma The pharmaceutical industry is facing complex challenges arising daily by continuous external demands , by mergers, by strict regulatory controls (FDA , ISO 13485 and 21 CFR Part 11 and other compliance standards ), by patents and by deadlines. The need to reduce costs is ever more pressing and so are requested management systems to manage quality processes . Before placing on the market , the drug is subjected to a complex phase to evaluate the effectiveness and possible side effects associated with their use. After the discovery of the active principle and its patenting, company will begin trials of pharmaceutical technique in order to evaluate the efficacy, tolerability and safety of the active ingredient . There are Good Manufacturing Practices guidelines that describe the minimum quality aspects that have to be taken into consideration for the production, control and release of a pharmaceutical product , making the manufacturer responsible for the design and manufacture of the product. Blulink solution supports Pharma industry in these requirements.

Overview

Quarta^®3 for the Pharmaceutical sector arises from the constant demands of a highly configurable and flexible solutions that can adapt to the changing regulatory landscape. With Quarta^®3 you can get a consolidated and centralized monitoring, use a powerful and flexible workflow, create reporting for all critical business processes that relate to the pharmaceutical industry. Quarta^®3 helps pharmaceutical companies, regardless of size, to optimize the processes of Quality, consolidate redundant systems, reduce manual tasks, increase productivity and comply with FDA regulations and other regulatory needs of the industry. With Quarta^®3 you can control and manage the documents of the quality, monitor performance indicators and optimize processes.