GxP Engagement: Medical Device Audit Preparation
The Project.
Medical Device Audit Preparation / Remediation
The Case.
Quality Culture overhaul, including Gap Assessments of existing processes, procedures and QMS.
Ensuring compliance and identifying gaps that require remediating. Validations, Data Integrity, Warehouse/Storage, Internal Training and resource management.
Ongoing Quality and Validation support. Performing Risk assessments, CAPA Evaluations and effectiveness checks, root cause analysis etc.
The Solution.
Project Team Deployed:
- Remediation Project Manager
- 2 x Validation Consultants (Data Integrity, CSV and EQV)
- 6 x Quality Consultants
- 2 x CAPA SME
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.
