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

Onsite

This course can be brought to your location. The expert instruction and training materials come to your facility. All you have to do is pick the time and place – we do the rest!

For more information on ISA's Onsite Training, or for a comprehensive needs analysis, please e-mail us.

For a confidential price estimate on bringing an ISA Europe course to your location, simply complete and submit the Onsite Training Quotation Form.