GMP Compliant MES Systems

Manufacturing Execution Systems (MES) bridge the information gap between ERP systems and process control systems. When these type of systems are used in a GMP regulated environment these systems may be subject to validation. ISPE issued a Good Practice Guide (GPG) on this subject.

After a summary of GAMP 5 and ISA-95, the GPG is explained in a practical way.

You will be able to:

• Understanding of specific requirements for Manufacturing Execution systems in a GMP environment
• Know the requirements for validated systems
• Understanding the GAMP guidelines for processes for use in specification, installation and maintaining validated MES systems
• Understanding a lean validation approach with GAMP and software development life cycles
• Knowledge of MES functionality and validation is required to follow this training efficiently

You will cover:

• ISPE Good Practice Guide “Manufacturing Execution Systems – A Strategic and Program Management Approach
• GAMP 5 ® principles
• ISA-95 part 1 (models and terminology) basic principles
• ISA-95 part 3 (activity models) basic principles
• Lean Validation approach

Classroom/Laboratory Exercises:

• Define Business case
• Functional domains
• Requirements definition
• Critical functions
• Mitigate risks

Length

1 day

Investment

€ 495,-, excl. VAT and inclusive catering.

Course data & times

24 June (thu), 9.00 - 16.30