Sanofi: 30 pharmaceutical sites under regulatory control

The pharmaceutical industry is probably the sector where maintenance is most demanding. Beyond economic performance, every piece of equipment, every procedure, every intervention must be traced according to GMP (Good Manufacturing Practice) standards imposed by the ANSM in France and the FDA in the United States.

For Sanofi, world leader in healthcare, regulatory compliance is not optional. A non-conformity can trigger a market recall, a site shutdown, or a license loss. Documentary control of maintenance is therefore a strategic asset as critical as production itself.

30 production sites, global standards

The project scope covered 30 pharmaceutical production sites spread across Europe (France, Germany, Italy, Spain, Belgium). Each site was certified according to several standards: ISO 9001, ISO 14001, European GMP, and sometimes FDA standards for sites exporting to the USA.

Before the project, the operational reality was complex:

• paper maintenance documentation representing hundreds of binders per site;
• regulatory audit preparation mobilizing up to 8 people for 2 weeks;
• traceability of critical interventions that was incomplete or delayed;
• heterogeneous tools across sites, with no group-level consolidation.

Full traceability and electronic signatures

The MAINTEX approach integrated pharmaceutical requirements from the design stage. The regulatory module meets 21 CFR Part 11 (FDA) and European GMP standards: certified electronic signatures, complete audit trail, granular access control.

Four pillars structured the rollout:

1. full digitalization of maintenance procedures with automatic versioning;
2. certified electronic signature for every critical intervention;
3. group-level consolidation of maintenance and compliance indicators;
4. integration with existing LIMS (Laboratory Information Management Systems).

A successful FDA audit in 4 days instead of 2 weeks

The first measurable benefit was on audit preparation. FDA and ANSM inspectors can now access the entire maintenance history in real time, without needing to request paper files or Excel exports.

FDA audit preparation time went from 2 weeks (mobilizing 8 people) to 4 days (mobilizing 3 people). Non-conformities detected during audits fell by 78%, mainly thanks to improved documentary quality.

MAINTEX enabled us to drastically reduce FDA audit preparation time and increase our compliance level. It is a strategic asset for our group.

A model scalable to the entire group

Beyond the initial scope, the project created a documentary and operational standard now deployed across the entire Sanofi group. The 30 equipped sites achieve 100% compliance on their latest regulatory audits, compared with a historical average of 85%.

The model is being extended to American and Asian sites, with the goal of unifying maintenance practice across the entire Sanofi industrial footprint by 2027.