中文

AUSTAR is committed to providing full life cycle solutions for laboratory informatization of pharmaceutical enterprises. From the initial pharmaceutical research and development to commercial production, AUSTAR laboratory informatization solutions cover research and development innovation, quality management, registration and application and other fields. With excellent quality and professional services, AUSTAR helps pharmaceutical enterprises accelerate the digital transformation, improve efficiency and avoid risks.

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R&D Innovation

Austar R&D innovation information platform focuses on the data recording and management of R&D laboratory, replacing the traditional manual writing mode with the electronic recording, ensuring the accuracy and standardization of data and improving the R&D efficiency.

  • The platform-based deployment mode and unified data management can structure the massive and scattered R&D data, which realizes data review and analysis;

  • The flexible process engine and rich project management functions enable scientists to plan the R&D progress;

  • The R&D innovation platform energizes industry users to innovate, promote cooperation, and accelerate knowledge sharing and transformation, improving the innovation ability and efficiency.

Quality Control

Austar provides digital, standardized, process and lean solutions for quality control of pharmaceutical enterprises. It covers quality assurance (QA) and quality control (QC) systems. Through the laboratory information management system (LIMS) and quality management system (QMS) to build a comprehensive quality control information platform.

  • Laboratory information management system (LIMS) is based on sample’s full life cycle management, which helps you optimize business process and improve management level; scientific data management and audit tracking can meet your regulatory and compliance requirements; flexible authority control and deployment facilitate your cooperation across time and region.

  • Quality management system (QMS) integrates document management, training management and quality management, assists enterprises in efficient management and use of business documents, quality documents and archives generated in the process of enterprise operation, as well as information management needs of training and various quality activities, helping pharmaceutical enterprises improve quality management level and avoid risks as it meets the GXP management standards at home and abroad.

IND or NDA

eCTD (electronic Common Technical Document), or electronic general Technical Document, is the key point of electronic CTD registration and declaration. Austar provides excellent eCTD products for users in the pharmaceutical industry, which are widely applicable to various stages of eCTD generation, validation, reading and archiving of pharmaceutical enterprises. It helps the registration department of pharmaceutical enterprises to improve the writing efficiency, standardize the document standards and shorten the application cycle.

  • Automatic release function, which can quickly generate technical documents that meet the requirements and shorten the application cycle;

  • Innovative collaboration function, which can meet the requirement of the division and collaboration of different roles in department so as to realize working seamlessly;

  • Systematic reading and archiving function, which can realize centralized storage and management of documents, and make the submitted eCTD documents clear at a glance.