Support for engineering changes

In the case of engineering changes, we support our clients in managing the compliance aspects for: changes in department(s) layout, new departments, change of equipment, insertion of new machinery, change of utilities, moving of equipment with or without change of use.

What we can do

• Opening change according to the customer's SOP
• Preparation of the AIFA notification
• Risk Assessment
• Updating of management documents
• SOPs update
• Qualification and validation
• Departmental documentation update
• Staff training
• Verification of compliance of the change

Experience and training
Our approach is based on the experience of the Senior figures of Adeodata in collaboration with the GxP Compliance Experts of Quality Systems.