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Overview

Drug 360 is a solution built for Pharma companies and Contract Research Organizations (CROs) who manufacture drugs to address their challenges in managing and maintaining the product and process data at pre-production stages of Product Lifecycle Management (PLM).

It helps the Pharma organizations to finalize the process of drug making, embed quality in the design and development processes at early stages of life cycle.

Drug 360 provides a common user Interface for all the departments to collaborate, define and maintain the quality standards in design stage that are needed to meet the regulatory requirements and the target profile that is set for a drug .

Drug 360 provides a common user Interface for all the departments to collaborate, define and maintain the quality standards in design stage

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The solution provides a predefined data model for drug design & development and offers the visibility and flexibility to all the stakeholders of the organization who typically work in isolated functional departments. This improves efficiency, productivity and reduces cost and time to market.

The Drug 360 solution, is a preconfigured, end-to-end reference solution, tailored to suit the design and development of drugs by Pharmaceutical and Contract Research Organizations. The solution has built-in extensible end-to-end business processes, for defining the Quality Target Product Profile, Critical Quality Attributes (CQA), Critical Material Attributes (CMA) and Critical Process Parameters (CPP) based on Quality by Design approach (QbD) and proven best practices of Drug design and development to bring in efficiencies and achieve greater business value with Microsoft Business Applications.

The solution is built using Power Apps, to enable faster design and development of drugs, reduced turnaround time, enhanced experience and superior quality.

Drug 360 solution

Challenges & Solutions

Preconfigured and compliant with regulatory standards for drug manufacturing

Provides a common user Interface and common database for the data to be maintained at one place

Provides for role-based access

Approval process at design substage level and restricting access to move further

Solution developed to maintain the quality standards based on systematic approach

Embedded quality framework helps bring in efficiency and improve productivity to reduce the time for drug design and development