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[ Quality ] 

Quality Management and Assurance is a constant necessity in the life science industry. The life science companies are regularly challenged to meet rising standards of quality and rigorous regulatory compliance requirements.

QCPT helps you to overcome the compliance challenges with following service portfolio:

  • Computerized System Validation according to industry guidelines, best practices and regulatory requirements: validation of IT systems according to GAMP, consulting software teams on Part 11 / Annex 11 requirements on functionality and system access and operation controls, system and project documentation, test management, definition of maintenance processes and controls, documentation of business processes mapped into the IT system, and many more.
  • GxP assessment of computerized systems, internal audit & remediation planning
  • Agile validation for IT systems/components according to industry guidelines
  • Providing eCompliance Quality Assurance and Project Quality Management services: Quality/Validation Planning and Control services for IT system implementations and projects including CSV consulting
  • Master Validation Planning and definition of Validation Frameworks for complex or strategic core IT systems (ERP, MES, PLM, LIMS, CTS, DRA systems, etc.)
  • Development and improvement of Quality Management Systems (QMS) and Validation Frameworks (including Standard Operating Procedure framework and documentation, processes and templates)
  • Evaluation and implementation support of QMS information management system
  • Qualification & Validation Services for equipment in lab / manufacturing, CQV services
  • Process Validation, PPQ
  • GMP (incl. GLP and GDP) Audit and Inspections
  • GMP Quality Assurance OfficersFor more details please contact us

For more details please contact us