System Implementation
The legal landscape of the Life Science industry is extremely dynamic in nature. To successfully traverse this landscape, firms require strong intellectual property and a pathway through the regulatory terrain.
01.
Business Process Harmonization
01.
Business Process Harmonization
Business Process Harmonization develop a business model on the basis of the organization’s existing business processes. It improves the efficiency, streamline business processes and reduces the operating cost, increases internal control and facilitates the interoperability. The decrease in number of process variants increases the agility towards changes in the process and lessen the cost of process maintenance.
02.
Business Analysis
02.
Business Analysis
Business Analysis is a research process which identify the needs of business, determining business solution, focuses on helping businesses and organizations, improving their success and taking advantage of market through data gathering and data reporting. Types of Business Analysis include Development of business, Improvisation of business process, Organizational change or Strategic Planning.
03.
User Testing
03.
User Testing
User Testing is a great way of getting user feedback & allows the researcher to take prompt action for website or app. The purpose of user testing to evaluate the usability. Software can be tested manually or through automation. Software testing helps to understand whether your software has errors, missing requirements and how to fix it . User Testing can be done through various means such as
Usability Testing
Surveys
The pain areas of regulatory compliance for Medical Device manufacturers are
The pain areas of regulatory compliance for Medical Device manufacturers are:
Process improvement and effective utilization of resources to sustain market competitiveness
Implementing GxP systems by effective change management
Rapid data recovery
Compliance to international regulatory norms (21 CFR Part 11, EU Annexure 11, GAMP)
Integrating diverse data transacted across business processes
The players in the ecosystem are constantly on the lookout for making meaningful and creative use of technology to bring together process, applications, infrastructure, and IT enabled devices for fruitful results.
Our Regulatory Excellence Services span all the Life Sciences industries (Medical devices, Pharmaceutical & Biotech Industries and Healthcare). We address the entire value chain of Life Science companies starting from Research & Development to prototyping and Manufacturing.
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