Business Central for Pharmaceutical Manufacturers - Requirements Overview
By Marc Braune, Managing Partner
Business Central is widely used by pharmaceutical manufacturers, but it is not GMP-compliant out of the box. The requirements it must be configured and validated to meet are well defined, and meeting them is a project — configuration plus computer system validation — not a licence purchase.
The requirements overview
Computerised systems and electronic records fall under EU GMP Annex 11 and 21 CFR Part 11. Underneath sits data integrity — ALCOA+ across the record lifecycle — and the pharma-specific ERP functions: batch and lot genealogy, expiry and retest date control, deviation and change control, and validated interfaces to LIMS, QMS, and MES. The validation approach follows GAMP 5, risk-based, so effort concentrates on the GxP-critical functions.
How Business Central fits
Business Central provides the ERP core; the GxP-critical parts are configured and validated for intended use, and specialised quality/lab systems integrate rather than being replaced. For the depth, see Business Central for the pharma industry and GxP validation for Business Central.
A short architecture governance review can confirm the design is audit-ready before an inspection.
Frequently asked questions
- What GMP requirements must a pharma ERP meet?
- EU GMP Annex 11 and 21 CFR Part 11 for computerised systems and electronic records; ALCOA+ data integrity; batch/lot genealogy with expiry and retest control; deviation and change control; and validated interfaces to LIMS/QMS.
- Is Business Central used in pharmaceutical production?
- Yes, widely — as the ERP for procurement, production, inventory, and finance — with GxP-critical functions configured and validated. It is typically integrated with specialised LIMS/QMS/MES systems rather than replacing them.