Our Services
Empowering Your Success Through Compliance & Innovation
Driving Quality Excellence for
Pharma & Medical Device Leaders
At the Quality Consortium we partner with you to solve complex quality challenges—
Improving processes, ensuring compliance and fostering innovation.
From regulatory alignment to operational efficiency our tailored solutions help your organization achieve lasting results.
We Offer…
…integrated, results-driven solutions to address your most critical quality and compliance needs
CQV|
Commissioning, Qualification, Validation
Protocol & Report Generation.
Installation Execution & commissioning.
Part & Id Traceability.
Operational Qualification Execution.
Process & Product Validations.
Process Control Design & Implementation.
MES / SCADA Implementations for End-to-End Visibility & Control.
Business Intelligence (BI) Reporting & Advanced Analytics.
Quality Systems | FDA/ISO Remediations
Document Control System Design & Implementation.
CAPA / RCA & Deviation Systems.
Plant-wide / Product Assessments & Ongoing Audits for Readiness.
IQA / Inspections, MDR & Complaints.
Plant-wide Performance Metrics & Process Control Reports.
Process Control (SPC), Capability Analysis (Ppk/Cpk) & Gauge R&R Studies (MSA).
Design Controls|New Product Development
Design Control Program Development.
NPD Program & Execution.
Design Input/Output Trace Matrix.
Design / Process FMEA Execution.
Design Verification & Product Validations.
Design of Experiments for multi-factor contributory analysis.
End-to-End Validations ensuring every aspect of your manufacturing operations meets industry & regulatory standards.
Project/ Portfolio Management
Experienced Portfolio, Program & Project Management Services.
Gantt, CPM, EV Analysis & WBS.
Agile-Scrum Methodologies.
Lean-Six Sigma (DMAIC) Methodologies.
Risk Management Matrix.
Stakeholder Analysis.
Project Plan & SWOT Analysis.
Process Flow Diagram Development.
