Expertise Cluster
Quality Management & Operational Excellence.
Establishment, maintenance, and auditing of robust, GMP- and ISO-compliant quality management systems that withstand audits and improve process efficiency.
Our areas of focus.
Filter our expertise by your industry.
Quality Management
QMS Structure
CAPA Management
Corrective Actions
Deviation Management
Deviation Management
Complaint Management
Complaints
Good Laboratory Practice
GLP Compliance
ISO 13485 certification
MedTech QMS
Lean Six Sigma
Process optimization
Lean Lab
Laboratory efficiency
Continuous Improvement
Continuous Improvement Processes
State-of-the-art assessments
SOTA Analyses
Computer System Validation
CSV / GAMP 5
Cleanroom Qualification
Cleanroom Qualification
Process validation
PQ & PPQ
ISO 9001 Audit
Quality Management
Automated visual inspection
AVI Systems
Discover more areas of expertise.
ENTOURAGE offers end-to-end solutions throughout the entire product lifecycle.
Cluster
Regulatory & Compliance
Regulatory strategies and global market launch.
ClusterClinical and Medical Affairs
Clinical strategies, study management, and PMCF.
ClusterR&D and Engineering
From research to design validation.
ClusterManufacturing & Supply Chain
Supply Chain Governance, Logistics, and GDP.
ClusterBusiness, Data & IT
Digitalization and IT Compliance (CSV, Part 11).
Digitalization with an understanding of the life sciences.
Describe your IT or data challenge—we combine technical expertise with regulatory know-how.