More then Project & Operation Quality Manager Services
[ 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 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.
Together with our partner network, we provide you with additional GMP, GLP and GDP related services:
Qualification & Validation Services for equipment in lab / manufacturing, CQV services
Process Validation, PPQ
Audit and Inspections
Quality Assurance OfficersFor more details please contact us