Overview

webassets/Cleanroom.JPG

Specializing in developing world class Quality and Compliance capabilities ACSYS associates bring an extensive knowledge base of best practices and tools delivering highly effective, focused recommendations for improvement. Using a proven assessment methodology, ACSYS focuses on:

Clinical Research, Quality Systems, Design Controls Process Excellence
FDA and European Medical Device Directive Readiness
Manufacturing Process/Systems Transfer, Validation, Startup
Regulatory Submissions
Audits
- Product Development / Design Controls
- Clinical Research / Trials
- FDA Readiness, Quality/Compliance
- Good Manufacturing Practices
- Validation
- Good Laboratory Practices
- Quality Control/Quality Assurance
Product and Process Validation
- Design Controls
- Equipment and Automation
Manufacturing Processes

The results are dramatic. We assist clients improve compliance of new products and manufacturing processes through implementation of high performing systems. The results are enhanced Regulatory compliance, increased speed to market, improved product quality, optimized product and process development, validation and production controls.