Quality Assurance/Quality Management Systems

Reducing Risk and Accelerating Clients’ New Technology

EVERSANA’s Quality Ccompliance provides a holistic lens across the product life cycleOur team understands that an effective and efficient Quality System is critical to successfully launch a global product that meets all regulatory compliance regulationsThe industry has increased its demand for more robust systems and experienced talent who know the evolving regulatory requirements because the costs of noncompliance are high: rejected product, delays to commercialization, product recall, product complaints, adverse events and/or agency actionOur Quality Compliance team is prepared for the challenge. 

Experience Matters

With more than two decades of experience, our team brings an unrivaled level of expertise in quality and regulatory compliance consulting, Quality System outsourcing, quality management systems, document control and training management software and services, tissue services, and donor eligibility system software and services. For a complete view of our experience across these services, visit eversanaconsulting.com.

Reducing Risk and Accelerating Clients’ New Technology 

 


Connectivity Across the Lifecycle

Through the integration of internal and external data and RWE combined with advanced analytics, our Quality Compliance team provides a predictive and proactive approach to insights that allows us to deliver continuous readiness models for regulatory inspections that are more cost efficient. The team is built with enhanced flexibility in mind and delivers ROI operational efficiencies, quality reputation and competitive advantages. 

Extensive Portfolio of Offerings

Quality Compliance Excellence 

  • Quality Systems 
  • Quality Systems Software 
  • Design Control Execution Support 
  • Process Optimization, Verification and Validation 
  • Didactic Training Sessions 
  • Quality Strategy (Pharma/Biologics/Tissue/Medical Device/Combination products) 

Regulatory Compliance/Auditing 

  • Gap Assessments 
  • Mock Audits/Inspections 
  • Due Diligence Assessments 
  • Inspection/Audit Management and Support 
  • Remediation 
  • General Auditing 

Take a Deeper Dive into our Services

Quality Assurance/Quality Systems

Quality Systems

  • Design, development, implementation, execution and optimization 
  • CAPA/Remediation planning and execution 

Design Control Execution Support

  • Design and development planning through design transfer 
  • Design verification and validation 
  • Risk analysis and risk management (ISO 14971) 
  • Embedded and stand-alone software (IEC 62304) 
  • Human factors and usability engineering (IEC 62366) 

Process Optimization, Verification and Validation

  • Lean manufacturing and Six Sigma optimization 
  • Implementation of manufacturing and supply 
  • Manufacturing and Quality System software 
  • Sterilization validation 
    • EtOgamma, electron beam, moist heat 
  • Cleaning and packaging validation 

Didactic Training Sessions

  • Quality Systems (FDA, EU, MDSAP), design control and risk management, verification and validation, CAPA handling, regulatory inspections, 21 CFR Part 11 combination products (21 CFR Part 4), etc. 

Regulatory Compliance/Auditing

Gap Assessments

  • Quality Systems, 21 CFR Part 11, product design and development (incl. software), CAP and CLIA 

Mock Audits/Inspections

  • FDA, MDSAP, ISO 13485, EU MDR 2017/745 / EU IVDR 2017/746 

Due Diligence Assessments

  • Quality System; product design and development 

Inspection/Audit Management and Support

  • Facility/systems inspection readiness  
  • FDA inspections 
  • ISO 13485 & MDSAP audits 

Remediation

  • Response strategies/documentation preparation 
  • Quality System, product DHF/medical device file/technical file compliance 
  • Product recall; corrective action strategy and execution 

General Auditing

  • Supplier quality (full program or single audit) 
  • Internal audit (full program or single audit) 
  • Supplier selection 
  • Manufacturing process/facility review 

Start working with the Quality Compliance partner you need to develop and launch your product before your competition does.