GxP and Annex 11 compliance for a pharma manufacturer

The client is a Swiss pharmaceutical manufacturer whose computerised systems were shipping faster than validation could keep pace. Under GxP, the gap between what is live and what is validated is a real regulatory and supply risk.

Validation existed in pockets rather than as a coherent, evidenced programme the business could point to.

Computerised systems were shipping faster than validation could keep up, leaving a widening gap between what was live and what was evidenced. The gap grew with every release.

There was no coherent, joined-up programme: validation existed in pockets, not as a standard the business could point to. Fragmented effort could not be assured as a whole.

With GxP obligations in force, that gap was a genuine regulatory and supply risk. Closing it was a necessity, not a nice-to-have.

We mapped the systems to GAMP 5 and Annex 11, categorising by risk so effort landed where it mattered rather than being spread evenly. Risk-based prioritisation is what delivered validated compliance in 12 weeks.

We closed the gaps that carried real regulatory weight first, and automated the collection of validation evidence so it stays current instead of decaying. Automated evidence keeps compliance live rather than a point-in-time snapshot.

The programme was designed to be sustainable after we left, not a one-off scramble, and we worked alongside the quality team so ownership transferred as we went. The manufacturer was left able to run it themselves.