Migration of supervision systems and qualification for a pharmaceutical plant

Migration of the systems comprises several phases:

• Migration of the WinCC V6.0 SP4 application to V7.5
• Re-establishing navigation of the supervision
• Setting up an OPC base (OLE for Process Control) for IP21 (InfoPlus.21)
• Virtualisation of the architecture
• Data security and time synchronisation
• Application audit trail: the audit trail is a traceability tool with a database where all operator actions, settings changes, and alarm events are recorded. This provides a data history, visibility of actions over an entire period, and the ability to extract data to create reports. In addition, a checksum process checks that the data in the audit trail is free from manipulation.

Assystem was involved at every stage of the project:

• Design phase
• Validation of the new network architecture
• Prototype creation
• Tests
• FAT (Factory Acceptance Test), SAT (Site Acceptance Test), IQ & OQ qualification phases (Installation and Operational Qualification)

• Making the site’s system consistent with the Group’s systems elsewhere in France
• Qualification of the systems on the platform (FAT) and then on the site (SAT) to guarantee their compliance with the 21 CFR Part 11 standard
• Optimum traceability of operator actions and production via the audit trail tool, for compliance with the regulations, to perform the necessary corrective and preventive actions, and to better organise production
• Limiting the number of non-compliances, and fast identification when necessary
• Reducing data loss and increasing the efficiency of production teams by tracking the production parameters