GxP · EU GMP Annex 11 · FDA 21 CFR Part 11 · GAMP 5
Pharmaceutical, cosmetics, chemical, and food and beverage manufacturers operate under compliance frameworks that make “the AI said so” an unacceptable answer. ForgePort was architected from the first commit on the assumption that every action must be attributable, reversible, and traceable. Not as a feature — as the architecture.
OTC manufacturers, supplements, medical devices. 30–500 employees. Batch release traceability, stability studies, supplier qualification.
GxP · EU GMP Annex 11 · 21 CFR Part 11
Colour cosmetics, skincare, contract manufacturers. Regulation (EC) 1223/2009, good manufacturing practice.
GMP · ISO 22716
Specialty chemicals, formulations, distributors. Substance registration, safety documentation.
REACH · CLP · GHS
Premium producers, private label, functional food. HACCP, allergen control, traceability.
HACCP · ISO 22000 · FSMA
Why governance architecture matters
An agent does not act without a human approver. Every approval carries the approver’s identity, timestamp, and reason. Auditors get a person, not a model.
The decision trace captures what data was reviewed, what was considered, and why the action was proposed. Structured, queryable, retained 730 days by default.
Write operations are queued before execution. Rejected proposals leave no footprint in the target system. Approved actions are logged with full context and can be rolled back if needed.
Compliance programme