ARAS
Aras Platform is unique in providing PLM landscape with low code development, rich application functionality and community solution.
PTC Windchill
PTC Windchill is a leading Product Lifecycle Management (PLM) platform designed to centralize and streamline product data.
Life Sciences
In the Life Sciences industry, Product Lifecycle Management (PLM) serves as a pivotal strategic framework that extends far beyond traditional product development.
It is an essential system for managing the entire lifecycle of medical devices, pharmaceuticals, and healthcare technologies, from the initial concept through to market deployment and ongoing support.
PLM offers a robust infrastructure designed to address the complex and highly regulated nature of life sciences products. With rigorous regulations imposed by multiple global health authorities, PLM ensures that each stage of development is thoroughly documented, tracked, and validated.
This comprehensive approach is vital for upholding the highest standards of patient safety, product quality, and regulatory compliance.
Regulatory Landscape and Compliance
The Life Sciences industry functions within a highly regulated environment, subject to a complex framework of requirements set by global health organizations, such as
FDA (Food and Drug Administration): The primary regulatory body in the United States.
EUMDR (European Union Medical Device Regulation) by EMA (European Medicines Agency) and the European Commission: Comprehensive regulations governing medical devices in the European Union.
Benefits of PLM
Comprehensive regulatory compliance management
Rigorous quality control tracking
Detailed clinical trial documentation
Accelerated medical device innovation
Complete product history and traceability
Unique device identification (UDI) management
Global regulatory complance
Challenges Addressed by PLM
The Role of UDI in Product Lifecycle Management
Unique Device Identification (UDI) has become a crucial component of PLM in the life sciences industry.
Provides a unique identifier for medical devices
Enables precise tracking throughout the product lifecycle
Supports improved patient safety
Facilitates effective recall management
Enhances supply chain transparency
Supports regulatory compliance across global markets
Case Studies
All Case
12
Business
1
Business Consulting
1
Corporate
1
IT Solutions
1
Marketing
1
Startup
1
IT Solutions Future
Cloud computing revolutionizes IT by offering scalable resources over the…
Integrated Innovations
Protecting digital assets is crucial in IT. Cybersecurity measures like…
Differentiated Performance
Big data involves analyzing vast datasets to uncover patterns and…
PLM in Life Sciences
The integration of advanced PLM systems with UDI tracking and multi-regulatory compliance mechanisms ensures that medical technologies meet the highest standards of safety, efficacy, and innovation.
Specializes in Product Lifecycle Management (PLM) and Engineering Services.