SOFTWARE VALIDATION
Medical DevicesDesign Controls
• Product Development Lifecycle
• Software Development Lifecycle
• Medical Device Software Validation
Production & Process Controls
• Quality System Software Validation
• Production Software Validation
Pharmaceutical
Computer Systems Validation
• Policies and Procedures
• System Development Lifecycle
• Infrastructure Controls
• Electronic Records and Signatures
Automated Systems
• Laboratory Information Systems
• Laboratory Equipment
• Enterprise Resource Planning (ERP)
• Enterprise Software Systems
• Custom and Off the Shelf
process validation
Medical DevicesProduction and Process Validation
• Prospective Validation
• Retrospective Validation
• Process Validation Studies
Equipment and Process
• Installation and Operation Qualification
• Process Performance Qualification
• Documentation
• Re-Validation
Pharmaceutical
Life-Cycle Approach
Stage 1 – Process Design:
Stage 2 – Process Qualification:
Stage 3 – Continued Process Verification
CA/PA
Medical DevicesEstablishing a CAPA system in accordance to 21 CFR 820.100
The CA/PA Process
Applying Key Steps of the CAPA Process
• Identification
• Evaluation / Risk Analysis
• Investigation / Planning
• Analysis / Root Cause
• Action Plan
• Implementation
• Following Up / Effectiveness
Following Global Harmonization Task Force Phases
Guided by QSIT Assessment
Pharmaceutical
Conducting investigation in accordance to 21 CFR 211.192 – FULL-SCALE OOS INVESTIGATION
"EngiSystems' goal is to become the global leader in forward-thinking, turnkey FDA compliance solutions
that enable manufacturers to bring safe, high-quality innovations to market quickly and profitably."
Major Clients Include: Johnson & Johnson, Boston Scientific, Cardinal Health and Terumo
that enable manufacturers to bring safe, high-quality innovations to market quickly and profitably."
Major Clients Include: Johnson & Johnson, Boston Scientific, Cardinal Health and Terumo