• Quality Assurance
    • Compliance as a Service (CaaS)
      • Optimization of existing and development of new Quality Management Systems (QMS)
      • Development of the Quality Management Pyramid acc. ISPE GAMP 5 consisting of e.g.:
        • Quality Manual
        • Policies
        • Procedures
        • Work Instructions
        • Plans
        • Standards
        • Guidelines
        • Templates
      • Lean Quality, application of Lean Principles to a QMS without compliance losses
    • Data Integrity
      • Training regarding Data Integrity (overview, compliance with multiple guidances)
      • Creating process flow / data flow diagrams
      • Performing risk analysis (FMEA)
    • Validation / Verification
      • IT validation
        • GAMP 5
        • ITIL
      • Analytical methods
      • Cross validation to pharmacopeias
      • Pharmaceutical / chemical production processes
    • Good Manufacturing Practice (GMP)
      • Implementation of GMP in production and quality control
      • Support of GMP audits
      • Support of customer audits and inspections by authorities
      • Authoring of documents (SOPs, etc.)
      • Authoring of specifications
      • Reviewing batch documentation
      • Reviewing analytical reports
    • Qualification
      • Computer infrastructure
      • Laboratory equipment according to GMP (DQ, IQ, OQ, PQ)
    • Supporting quality processes
      • Technical complaints
      • Deviation management
      • CAPA management
      • Change management
  • Quality control
    • Qualification of laboratory equipment
    • Organization and optimization of laboratory processes / activities
    • Method development
      • HPLC/UPLC
      • LC-MS
      • MALDI-ToF
    • Method validation
    • Definition / identification of raw data
    • Evaluation / release of raw data

Quality Management (QA)
 | Business Process Analysis (BPMN) | Computer System Validation (CSV)  | Projekt Management (PMO) | Manufacturing Execution Systems (MES)



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Helmut M. Rector
mobile: +49(0)163 246 2978
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