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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:

  • Validation Services
    - eCompliance Quality Assurance / Impendent Quality Services
    - Project Quality Management / Validation Lead Services
  • Computerized System Validation according to industry guidelines, best practices and regulatory requirements including
    - System and project documentation
    - Test planning and management
    - Definition of system maintenance processes and controls
    - Documentation of business processes mapped into the IT system
    - and many more
  • Consulting software development teams on implementation of Part 11/Annex 11 functional requirements including security and operation management aspects
  • GxP assessment of computerized systems for
    - Internal Audits and Inspections
    - GxP remediation planning due to CAPAs
    - New GxP requirements due to integration into new quality frameworks as a result of M&A projects
  • Agile Validation by experience experts (SAFe SPC Implementation Consultants)
  • Definition of Validation Frameworks & Master Plans for
    - Complex or strategic core IT systems (ERP, MES, PLM, etc.)
    - ServiceNow-Validation
  • Implementation of Quality Management Systems (QMS) and Validation Frameworks including SOP framework, processes and templates, etc.
  • Qualification & Validation Services for equipment in lab / manufacturing, CQV services
  • Process Validation, PPQ
  • Audit and Inspections
  • Quality Assurance OfficersFor more details please contact us
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