Having a well-defined strategy is the key to quality and compliance management. However, companies often don’t have the time and/or resources to address systemic quality issues and/or to improve quality systems.

Terrell QMS Consulting Inc. will put you on track to successfully achieve your company's long and short-term goals using proven project management processes.

Project management, planning, and implementation of:

• Compliance (SOP's, ISO & FDA Requirements)
  • ​​Assessment

• Auditing
• Gap Assessment
• Master Compliance Planning
• FDA, ISO, EU MDR, MDSAP

• ​​Quality Systems (QSR Setup, Policies & Procedures)
  • Define, Document, and Implement

• Quality Assurance
  • Quality Management
  • Quality Control
  • Quality Engineering
  • Software Quality

• Validation Project Management
  • Process Validation (IQ, OQ, PQ, CPV, Master Planning & Process Control)
  • Computer/Software V&V (Life Cycle) & Automated Processes
  • Scrum Master
  • Test Methods

• CAPA
  • Complaints
  • Investigations
  • Root Cause
  • Corrections & Removals
  • Remediations

• Process Control
  • Data Driven Problem Solving
  • Process Evaluations
  • Statistical Process Control (SPC)
  • Basic Statistical Techniques (Normality, Process Capability, etc.)
  • Advanced Statistical Techniques (ANOVA, DOE, Regression, MSA, etc.)
  • Statistical Rationale (Sampling Plans, Data Analysis, etc.)

• Information Technology Support
  • Quality Information Systems Requirements
  • Laboratory Information Management Systems
  • Electronics Records Management
  • Statistical Analysis Software Applications