Quality Assurance

Superior flexibility and tailor-made quality assurance strategies assure seamless quality system integration or optimization into customer’s existing systems. Once systems are established, Avanti Europe can support in process optimization with trained six sigma green and black belt personnel as well as introducing lean principles to processes. Our Quality Assurance consultants do balance efforts and quality in a pragmatic and entrepreneurial way to offer a bespoke solution to customer’s needs.

Expertise and Experience in Quality Assurance:

  • Development of bespoke quality systems (e.g. integration of medical devices QSR into pharmaceutical PQS)
  • Implementation of quality systems according to ISO9001, ISO13485, GMP, GACP
  • Quality audits, unannounced audits and medical devices single audit plan (MDSAP)
  • Gap assessments and quality due diligence audits
  • Verification and Validation (incl. for software)
  • Investigations, problem solving and root cause analysis
  • Corrective and Preventive Action (CAPA)
  • 8 disciplined approach to problem solving (8D)
  • Kepner Tregoe problem solving
  • Lean and six-sigma integration into existing QA systems
  • Quality by Design (QbD) and DoE implementation into existing QA systems
  • Customer-specific training (in-house or as eLearning)

We have supported:

  • Medical Device Quality Management System (QMS) updates to ISO 13485:2016
  • Product Documentation update to meet Medical Device Regulation (MDR) requirements
  • Combination Product remediation to align with 21 CFR 4, 21 CFR 820 and ISO 13485
  • Implementation of QMS/QSR requirements into established PQS system to fulfill 21 CFR 4 requirements
  • Digitalization of CAPA process and implementation of tailor-made software solution
  • Multi-site CAPA and remediation projects
  • Full-fledged risk-based control strategy
  • Establishment and implementation of APQR and PSUR
  • Assignment as Qualified Person (QP) and Person Responsible for Regulatory Compliance (PRRC)
  • Ad-interim QA Manager for new product development in medical devices, combination products and pharmaceuticals
  • Ad-interim QA Manager for phytopharmaceuticals

Why Avanti Europe is the right address:

For quality assurance, Avanti Europe is the right address as we hold the following critical certification and skill sets:

  • Certified Quality Assurance Managers
  • Certified Project Managers
  • Experienced change agents
  • Pragmatic approach to complex SOP landscapes and established Quality Systems
  • Interdisciplinary network of experts

Contact us to explore our skill-set and discuss your projects or ad-interim staffing needs.