Quality Management Systems
“We cannot solve our problems with the same level of thinking that created them.” — Albert Einstein
Our primary goal is to provide best-in-class, value-added consulting services to our clients. We utilize proven, time-tested quality tools and strategies and tailor them to the life science industry, resulting in consistently successful projects.
- Quality Management Systems Design
- QMS Assessment
- QMS Remediation
Quality Management System Design
Strategic Planning & Assessment
- Map the "Present State"
- Gap Assessments
- FMEA
- Develop the "Future State"
- SWOT Analysis
- Sustainability
- Alignment with organizational culture
- Set SMART goals
Implementation / Remediation
- Compliance to regulations, guidance, best industry practices, benchmarking
- Close identified gaps
- Process improvement & upgrades
- Knowledge Transfer
Monitor/Verify
- Verify "State of Control"
- Use of Proven Performance Measurement Tools
- On-going Management Awareness
Quality Management Systems – Example Projects
| Client | Problem/Opportunity | Solution | Outcome |
|---|---|---|---|
| Sterile Compounding Pharmacy | Large 483, FDA Warning Letter, Weak Quality System | Full QMS assessment, Corrective Action Plan, Implementation of redesigned Policies & Procedures | Successful follow up inspection, and fruitful meeting with FDA at local office |
| Rx Drug Manufacturer | Launching a new product at Consumer Product CMO with weak QMS | Series of FMEAs to identify all high risk areas. Developed/improved GMP infrastructure and procedural controls | Successful PAI and launch of first commercial product |
| Large Topical Drug Manufacturer | Disturbing 483 inspection report, Warning Letter | Assessment of all areas of concern. Implementation of design and procedural controls | Favorable follow up inspection, lifting of Warning Letter |
Client – Sterile Compounding Pharmacy
Problem/Opportunity
Large 483, FDA Warning Letter, Weak Quality System
Solution
Full QMS assessment, Corrective Action Plan, Implementation of redesigned Policies & Procedures
Outcome
Successful follow up inspection, and fruitful meeting with FDA at local office
Client – Rx Drug Manufacturer
Problem/Opportunity
Launching a new product at Consumer Product CMO with weak QMS
Solution
Series of FMEAs to identify all high risk areas. Developed/improved GMP infrastructure and procedural controls
Outcome
Successful PAI and launch of first commercial product
Client – Large Topical Drug Manufacturer
Problem/Opportunity
Disturbing 483 inspection report, Warning Letter
Solution
Assessment of all areas of concern. Implementation of design and procedural controls
Outcome
Favorable follow up inspection, lifting of Warning Letter