Where Quality Systems Consulting & Contracting can help.

If you have short-term (3 months), mid-term (6 months) or long-term (12 months or more) problems to solve, or needs to fill in the any of the following consulting circumstances or contracting scenarios, I can help.  

Regulatory Compliance

• FDA Audit Prep, Support, Results (mitigations)
• Notified Body Inspection Prep, Support, (mitigations)
• Internal Audit Prep, Support, Results (mitigations)
• Electronic Signatures, Electronic Records Processes
• Computer Software Assurance / Computerized System Validation
• Adverse Event Reporting / Post Market Surveillance / 
• Complaint Handling / Investigations / Recalls
• Top Management and Quality System Representative Designations

Quality System Leadership

• Product and Process Nonconformances
• Corrections, Corrective Action, Preventive Actions
• Product Risk Management
• Compliance Training
• Management Reviews

Good Manufacturing Practices (GMP's)

• Quality System Maintenance / Process Development
• Design Controls, Document Controls, Change Management
• Software Development Lifecycle (IEC 62304)
• Formal Design Reviews
• Employee Competence

I can work within your existing quality system, or help you develop, maintain, and update compliant quality system processes.