Overview

EZEN helps life sciences organisations (MedTech, Biopharma, and CROs) improve their Quality and Compliance Management thereby optimising time and efforts while ensuring inspection readiness.

EZEN QMS Expertise

EZEN has expertise in implementing risk-based Quality Management System compliant with regulations across the Life Sciences Industry.

EZEN has experience with certification requirements and implementing ISO13485, 14971 IEC 62304 standards.

EZEN Experience: Defining GAMP-based Computer System Validation Methods.

Thought leadership: EZEN has deep insights into the emerging trends, points of view on Compliance in Cloud, Robotic Process Automation (RPA), Artificial Intelligence.

Capabilities

Expertise in building risk-based

Expertise in building risk-based Quality Management System compliant with regulations across Life Sciences Industry

Experience defining GAMP

Experience defining GAMP based Computer System Validation methods

Experience in certification requirements

Experience in certification requirements and implementing ISO 13485, 14971, IEC62304 standards

Thought leadership-Deep insights

Thought leadership: Deep insights into the emerging trends, Points of View on Compliance in Cloud, Robotic Process Automation (RPA), Artificial Intelligence

Deep industry expertise working across life sciences companies across the globe.

Our Services

Our purpose is to help Life Sciences organizations improve their Quality and Compliance Management thereby optimizing
time and efforts while ensuring Inspection readiness.

End to End Validation Services

End to End Validation CoE Services

Create plans and summary reports, Perform assessments (Part 11 Assessment, Functional Risk Assessment), Execute IQ, OQ, PQ scripts, Document SOPs and Work Instructions.

Advisory and Enabling

Advisory and Enabling Emerging Technologies and Transformations

Leadership coaching, Points of View, White papers, Assessments, Remediation strategies.

Audits and Inspection Readiness

Audits and Inspection Readiness

Conduct Vendor Audits, Internal audits, Periodic Reviews and Inspection Readiness checks. Create and maintain Remediation plans. Manage CAPA

Legacy Remediation

Legacy Remediation

Perform Impact Assessment, Define Remediation Strategy, Execute Remediation plans and document summary reports

QMS Services

QMS Services

Define IT Quality Management Policies, SOPs and organizational guidelines

Other Services

Other Services

Technical Writing Records Management Services Validation Services for System Retirements