
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.