Our Client’s Background
A Global Leader in Medical Device Manufacturing for over 100 years.
Headquartered in Tokyo where they provide top-quality products and services to patients worldwide, with over 30,000 associates delivering innovative solutions in 160+ countries and regions.
Originally founded as a Japanese thermometer manufacturer, our client has continuously supported healthcare.
Their portfolio spans vascular interventions, cardio-surgical solutions, blood transfusion and cell therapy technologies, and essential medical products like transfusion systems, diabetes care, and peritoneal dialysis treatments.
Given the constantly evolving landscape of regulations—from environmental laws to quality certifications—the organization recognized the need for a unified compliance management system to stay ahead of legal and regulatory requirements. To address this, our client turned to Lawrbit’s Global Compliance Management Solution Network
Challenges Faced by the Client
Our client operated in a complex compliance landscape shaped by their unique business and operational intricacies. This complexity led to several challenges, particularly in meeting stringent safety and compliance standards across various areas, including raw materials, manufacturing processes, and packaging. The need to adhere to evolving regulations, ensure consistency in quality, and maintain efficient operations while remaining compliant were some of the key challenges faced by the client.
- Unidentified risks in corporate, ethical, social, and business areas increased the potential for unforeseen challenges, compliance issues, and negative outcomes.
- Well-informed employees drive optimal performance by ensuring full compliance with policies, laws, and regulations, minimizing risks and ensuring success.
- Compliance and industry law updates were not managed effectively through manual processes, leading to potential gaps in adherence and knowledge.
- The organization relies heavily on manual processes and spreadsheets to track compliance status, leading to inefficiencies and potential errors.
- Missed statutory notices resulted in missed deadlines, increasing the risk of legal penalties and compliance violations for the organization.
- The lack of clear compliance records increases the risk of missing requirements, which may result in penalties and legal issues.
Lawrbit Regtech Engagement
Lawrbit’s Advisory Team began GCSM implementation in March 2023 and completed it within 6 weeks. A team of 2 Subject Matter Experts (SMEs) was formed to collaborate with the Compliance Officer and General Counsel in planning the implementation.
GCMS Implementation was carried for 2 locations. The GCMS went live in April 2023 along with the Internal Compliance Module.
Following steps were followed to go-live.
- Business Discovery
- Business Setup:
Group structure, entities, locations, number and nature of establishments, industry involvement, and exports. - Products:
Medical Pens, Thermometers, Oxygen Concentrators, Bipap Machines - Mandatory Repeatable Items:
Driven by ISO and other standards. - Statutory Compliances:
Adherence to the Medical Device Rules, Drugs Price Control Order, Drugs & Cosmetics Act, Legal Metrology Act, FEMR, Custom Act, Import & Exports regulations, FTP Policy and other relevant statutory requirements.
- Business Setup:
- Compliance Applicability Assessment
- Identification of critical compliances across the functions, under various Acts, guidelines, and regulations across different regions.
- International product safety standards, environmental regulations, and safety guidelines. Compliance with EPR regulations were obligatory for packaging, and disposal of products.
- Minimizing environmental impact and using sustainable practices. Adhering to rules on emissions, waste management, and resource usage during production.
- GCMS Implementation: (At client’s corporate office & warehouse)
- Review of Identified Applicable Acts and Compliances: Engagement with key stakeholders for thorough assessment.
- Discussion on Identified Gaps:Consultations with CXOs, Regional Heads, and the Compliance Head.
- Entity and Locations Mapping: Structuring the client’s group and entities according to establishment types and locations.
- Compliance Mapping: Assigning specific compliances to relevant users based on their roles.
- Training and Edification: Sessions for the user groups tailored to their functions, roles and work sites.
GCMS Coverage
2
Locations
60+
Applicable Acts
850+
Compliances
25+
Users
3
Management Users
Internal Compliance Module (ICMS): To efficiently manage the company’s internal policies, quality reports, notices etc.
ICMS Coverage:
- Human Resources
- Quality Regulations
- Legal
- Sales departments
Conclusion
The GCMS is successfully implemented for:
- Centralizing and automating compliance tracking
- Improved operational efficiency
- Reduced compliance risks
- Strengthened governance framework.
The solution has enabled our client to focus on its core business—innovation, quality production, and market growth—while being compliant with a broad range of industry regulations.
Lawrbit’s integrated approach to compliance management has proven invaluable in supporting our client’s commitment to regulatory adherence and operational excellence, positioning it for continued success in a complex and ever-changing regulatory environment.
