Features of eCompliance

What eCompliance do for your project?

We work on behalf of your Japanese affiliate's staff to help….

• Project Management NEW
• Argus Implement support NEW
• Documentation Support (User Materials, Validation)
• Interaction Support　(Bet. HQ and Japanese Affiliate)
• Translation and interpretation
• Advising on global solutions

and more...
We will support your business to be succeeded in short-time and best practice with experiences.

Remarks : Argus is trade mark of ORACLE.

Features of eCompliance

1. Total consultation

We can offer total consultation service with depth knowledge of Business process and regulatory requirements.

• Implementation consultation
• Project management
• Business process construction, SOPs creation consultation
• Consultation and performance support corresponding regulatory requirements of EMEA, FDA and MHLW and CSV(GAMP 5), Part 11 and ER/ES

Examples of Service contents
Regulatory requirements assessment and report to be corresponded in each country, Requirements assessment and adjustment of overseas affiliate, Global meetings (including telephone/video conference) support, Package assessment support in each company, New process (Global process) decision support, Global SOPs creation support, CSV(GAMP 5) and Part11 corresponding support (Performing validation), Vendor management support, Cooperation with local system and global system consideration support, Project management support, FDA audit corresponding support, Introduction of corresponding state of other companies (Best Practice)

2. Skills

Consultants who are fluent in English and have abundant experiences use assets and proceed the project in directive style.

• Depth knowledge of regulatory requirements of EMEA, FDA and MHLW
• Knowledge and Comprehension of Safety Information Management Business
• Monitoring of latest trend EU and FDA all the time
• Project management skills
• CSV(GAMP 5) and Part 11 corresponding support
• Fluent in English and be familiar with cultures in EU/US
• Creating materials in English, Interpretation and Translation

3. Consultation without dependence on products

We can offer consultation laid weight on your Japanese affiliate's profit and operational convenience from neutral position concerning products.

• Be able to assess package from neutral viewpoint
• Have abundant information cooperating with vendors

4. Penetration to the industry

We always lead the industry by giving seminars and disclosing information at website.

• Name recognition
• Contract results over 40 companies