GxP Engagement: Medical Device Audit Preparation
The Project.
Medical Device Audit Preparation / Remediation
The Scope.
i-Pharm GxP was engaged under a defined Scope of Work to support a quality culture overhaul, including gap assessments of existing processes, procedures, and the QMS.
The agreed scope included ensuring compliance and identifying areas requiring remediation across validation, data integrity, warehouse and storage, internal training, and resource management.
It also included ongoing Quality and Validation support, including risk assessments, CAPA evaluations and effectiveness checks, and root cause analysis.
The Solution.
To execute the agreed Scope of Work, i-Pharm GxP deployed a dedicated project team:
• 1 x Remediation Project Manager
• 2 x Validation Consultants (Data Integrity, CSV, and EQV)
• 6 x Quality Consultants
• 2 x CAPA SMEs
The Outcome.
Successfully built a team that enacted a quality culture transformation, remediating extensive issues across QMS, manufacturing, data integrity, and CSV.
The team from i-Pharm GxP successfully enacted a quality culture transformation.
