EZEN helps Life Sciences organizations (MedTech, Biopharma, CROs) improve their Quality and Compliance Management thereby optimizing time and efforts while ensuring Inspection readiness.
EZEN QMS Expertise:
EZEN has expertise in implementing risk-based Quality Management System compliant with regulations across Life Sciences Industry
EZEN has experience in certification requirements and implementing ISO13485, 14971IEC62304 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
Audits and Inspection Readiness
Conduct Vendor Audits, Internal audits, Periodic Reviews and Inspection Readiness checks. Create and maintain Remediation plans. Manage CAPA
End to End Validation 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 Emerging Technologies
Leadership coaching, Points of View, White papers, Assessments, Remediation strategies
Strategies for Journey to Cloud, Data Center Migrations, Tool Qualifications, Strategies for Artificial Intelligence, Machine Learning capabilities and BOTs.
Define IT Quality Management Policies, SOPs, and organizational guidelines