Context and challenges
This client, a leading pharmaceutical group, provides innovative therapeutic solutions and markets more than 200 medicines, vaccines, and healthcare products in France. This client has several production sites, including a site specialised in the manufacture of basic pharmaceutical products.
At present, the supervision systems on this production site do not fully meet this group’s current system standards. This site therefore needs to upgrade its supervision systems.
In this context, this client has tasked Assystem Care with migrating the supervision systems. Assystem Care has been operating on this site for several years, and is fully familiar with the instrumentation and control systems on the site and the technologies to be deployed.
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
- 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