Maintenance of validated state of GxP systems (1 day)

Objectives of internship 

• Understand and assimilate the process of maintaining the validated GxP state of computerized and automated systems according to the GAMP5 approach
• Assimilate and apply the modular approach of GAMP 5 and the new requirements related to “Data Integrity”
• Understand and apply the “Risk Analysis” approach to comply with 21CFR part 11, Annex 11 and the new Data Integrity guidelines.
• Knowing how to define the activities and the necessary effort to maintain the validated state of each computerized system by assimilating a “modular” approach: exchange management, periodic reviews …

Teaching methods

• Course based on GAMP 5 methodology and Data Integrity requirements
• Concrete case studies
• Work in sub-groups
• Exposed

Staff concerned

All the people involved in the validation of information and automation systems (ERP, CAPM, LIMS, SCSE, WMS, SCC, MES, PLCs, etc.): Information System and automation project managers (functional and technical) , User project managers, Validation managers, Quality Assurance department representatives, etc.

Dates and costs 2022

June 23th 2022 – Paris / October 19th 2022 – Lyon

Cost: 680 € excl. Tax including breaks and lunch

DETAILED PROGRAM

1 — REMINDER OF THE REGULATORY REQUIREMENTS FOR MAINTAINING A VALID STATE

2 — PRINCIPLES OF MAINTAINING A VALIDATED STATE

• Key points
• Positioning of the maintenance of the validated state in the system validation lifecycle
• Description of a complete maintenance process
• Activities and documents relating to the maintenance of validated systems: periodic reviews, subcontracting, security and access, change control, archiving of records, backup and restoration of systems, operational continuity
• Zoom on “Change control”

3 — IMPLEMENTATION OF THE “OPERATIONS” PHASE

• Definition of the applicable scope: infrastructure, software, applications, data
• Definition of the organization, responsibilities, necessary activities
• Development of documents, procedures and records necessary for the various activities of the maintenance process: periodic reviews, subcontracting, security and access, change control, archiving of records, backup and restoration of systems, operational continuity

4 — PRACTICAL EXERCISES

• Exercises to set up a maintenance process
• Exercises in writing “change control” procedures, system backup / restoration, periodic review, “service charter” for subcontracting.

Pharmasys is an approved organization (activity declaration number: 11 91 0806691) and listed in Datadock. It is therefore quite possible to go through your OPCA for the financing of the latter. You will find all the information you need to create your request for assistance in the training contract that will be sent to you.

We are at your disposal for any request for additional information.