Consultancy

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QA & Validation Consultancy

With Corelas I offer consultancy services in the field of Validation, Quality and Compliance for the pharmaceutical industry. As freelance consultant I can help your company to achieve compliance with applicable regulations, and to assure that systems will function and continue to function in accordance to your expectations.

Examples of functions for which I can apply:

  • Management of teams responsible for validation and/or quality assurance in project or operational settings
  • Coordination of validation activities including planning, training of project team for quality and documentation aspects, change management, document reviews, risk assessments, etc.
  • Execution of functional and user acceptance test scripts for LIMS, SCADA, CMS, EMS, etc.
  • Document writing including procedures, requirement specifications, testprotocols, user manuals, risk assessments, gap analysis, etc.
  • Quality assurance, quality oversight including review and approval of key deliverables, deviation management, project quality oversight, etc.
  • Remediation projects, e.g. establish or improve existing quality systems, assessments for regulatory compliance, on-site training, etc.

Area's of expertise

Regulations
  • 21CFR 210-211, 600, part 11
  • EU Directive 2003/94/EC
  • Eudralex Volume 4 and annexes
  • WHO and PIC/S GMP guidelines
  • 21CFR 210-211, 600, part 11
Standards and guidances
  • GAMP 5 guidance
  • ASTM E2500
  • USP and EP monographs relative to WPU, cold storage
  • ISO 9001
  • ISO 14644
  • ISO 27002
  • ISPE baseline en good practice guides
Specific methodologies, techniques
  • V-Model
  • Risk Analysis using FMEA
  • Root-cause analysis using Ishikawa (Fishbone diagram)
  • SWOT analysis
  • Compliance assessments and gap analysis : 21CFR Part 11, Eudralex volume 4 annex 11
  • Good testing practices in IQ/OQ, functional software testing, user acceptance testing
  • Technical writing, reporting
  • Good documentation practices, document management and records retention
  • Good practices related to system security (access control, disaster recovery, data security, etc.)
  • Decommissioning of computerized systems
  • Data migration
  • Change management during different lifecycle phases (commissioning, validation, operational phase)
  • Supplier audits and supplier management
  • Certification of clean rooms (in accordance to ISO-14644)
  • Temperature mapping

Joachim Nuyttens