Computerized System Validation (CSV)

Computerized System Validation (CSV)

Strengthen Compliance by Validating Every System — from Software to Shop-Floor Automation

Serialization and Track & Trace (475 x 600) (2)
Serialization and Track & Trace (475 x 600)

Target Audience

QA / QC
IT and Automation Teams
Production and Shop-Floor Operations
Validation Teams
Engineering Teams
Project & System Implementation Teams
Data Management and Documentation Staff 2-Computerized System Validation

Course Outline

Day One

Introduction to Computerized System Validation (CSV) and regulatory context

Validation principles and foundations

Definition of Computerized Systems
Definition of Validation
Definition of CSV
Elements and principles of validation

Understanding FDA and EU expectations for CSV and regulatory enforcement

Quality standards and SDLC (Software Development Life Cycle)

IEEE
GAMP
SDLC definition and models

Validation Master Plan (VMP), Verification (DQ), and Qualification stages

IQ, OQ, PQ and their documentation requirements

Workshop: Comparing regulatory requirements and SDLC approaches

Day Two

CSV strategies for different system types

Custom-built systems (GAMP Category 5)
Configurable LIMS / eDMS (GAMP Category 4)
Shop-floor systems (PLC / SCADA) (GAMP Category 4)
Off-the-shelf systems (Excel templates) (GAMP Category 3)

ERP validation using SAP as a real-industry example

Where to start
Modules involved
Role of teams and deliverables
Validation strategy and testing expectations

Predicate Rule and 21 CFR Part 11

Electronic Records / Electronic Signatures
Access control, audit trail, authority checks, exact copies, signature control, compliance strategy
Process control systems and spreadsheets

FDA Warning Letters — lessons learned and interpretation of actual 483s

Workshop: Creating a VMP for an ERP System CSV Project

Duration

Two days

Key Takeaways

Understand CSV methodology, documentation requirements, and quality standards
Learn how to establish validation strategies for different system categories
Gain practical competence in VMP, DQ, IQ, OQ, and PQ execution
Apply CSV requirements to SDLC, GAMP, and ERP systems
Understand and prevent compliance failures that lead to FDA Warning Letters and 483 observations
Speak to a Training Specialist

Contact

  • Building #10, Ground Floor, Business Park, Amman, Jordan
  • +962 (79) 1533337
  • m.abuzour@agonme.com

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We understand the importance of approaching each work integrally and believe in the power of simple.

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