Quality Management System (QMS)

HOYA Digital Solutions provides our customers with QMS solutions such as MasterControl™ to meet the strict regulations, based on our extensive experience in supporting customers in the life science industry.

Convert challenges of stringent compliance requirements into your advantages with MasterControl™

MasterControl ™ is a global standard for integrated QMS software, adopted worldwide by prominent players in the pharmaceutical and medical device industry, including FDA (U.S. Food and Drug Administration). In combination of this powerful product with our extensive experience in HOYA Group's global businesses, we provide you with a QMS solution that is truly valuable for your business.

MasterControl™

Overview of MasterControl™

Importance of Compliance

Concerns about quality management

  • The design change process is not clearly defined.
  • The process for customer complaint management is not structured well to track and address the root cause.
  • Complicated process and incomplete recording of quality training.
  • Incomplete revision/change control with paper- and Excel-based document management.
品質マネジメントがうまく行っていない

Concerns about conformity and compliance

  • Preparedness for inspections by overseas authorities such as FDA and EMA
  • Nonconformity pointed out in supplier audit
  • Incomplete Computer System validation (CSV)
  • Compliance with digital signature and data regulations such as ER/ES and Part 11 is insufficient.
現行のしくみでは、監査や法令への対応に不安がある

Our solution, MasterControl ™, provide you with:

Optimum design and accurate execution of Quality Management

By visualizing cumbersome processes and clearly organizing them, you can stably run the PDCA cycle in quality management. Our solution helps optimize work processes based on our extensive experience in the medical device industry, and enables smooth operation by digitizing the processes with MasterControl ™.You will be able to accurately perform everyday tasks such as document version and change control, planning and tracking of training, and management of customer complaints and other quality events.

Strong confidence in auditing and compliance, backed by best practices

Through our extensive experience in the field of life science, we have accumulated best practices. We offer numerous templates and frameworks that are compliant with domestic regulations and ISO as well as international standards such as FDA, ICH and IMDRF to address your concerns about inspections, audits and compliance.

Features

Flexible Configuration

Every customer has its unique and detailed requirements for elements in the QMS, such as items in the complaint report, the approval route to change documents, among others.
MasterControl ™ is designed to be flexible in responding to diverse requests from customers that it can be implemented with minimum impact on your business processes.
It also offers intuitive settings for your convenience.

High Extensibility

MasterControl™ offers a highly extensible interface, making it easy to cooperate with other systems. Seamless, comprehensive QMS can be built by smoothly linking peripheral systems such as ERP, PDM and MES and existing QMS related applications.

Global Support

More companies are going global every day, operating sites in numerous countries and doing business in multiple languages. MasterControl™ now offers its world renowned document and quality management solution in nine languages: English, French, German, Japanese, Chinese (Simplified and Traditional), Korean, Italian, Portuguese, and Spanish.

グローバル対応

Adopted by FDA (U.S. Food and Drug

The fact that MasterControl ™ is adopted by FDA's Office of Regulatory Affairs (ORA) brings a great sense of security, especially to customers who place importance on businesses in the United States.

Cloud-based QMS

Cloud-based solutions are also available. To find out more, please contact us.

Our Advantages

We have contributed to various customers based on our extensive experience and achievements both as a EQMS user and a service provider. Items that are particularly strong are as follows.

1. Abundant business knowledge, experience in the life science industry

Engineers are familiar with the life science industry / business. It has been cultivated by responding to various requests at HOYA which is a medical device manufacture, and other customers which is pharma industry.

2. Full consideration of operation

We will realize the system that is suitable for your daily business operation. We clarify the business flow, user and system usage, and implement the system by fully considering usability and flexibility as well as training and support.

3. Global support

We can provide with support and consultation on globalization and overseas rollout, through our know-how cultivated by supporting 110 oversea companies in 38 countries.

4.High quality process

We provide high quality services by improving quality by adopting International Development Guidelines (CMMI) for the system implementation process and ITIL for the operation support process.