Regulatory Watch
Regulatory Watch, October 2026
Five regulatory events from October 2026. For each one: what happened, and what to check in your own Quality Management System.
Guides
What a quality system costs, what validating one involves, how to choose one when you have no IT department, and Regulatory Watch: what regulators found, and what to check in your own system.
Before you choose a Quality Management System
Compliance
21 CFR Part 11 when you have no compliance department
Some Part 11 clauses are met by software. Others can only be met by procedures you write. Buying the first does not give you the second.
Choosing a system
Choosing a QMS when you have no IT department
Most quality software assumes staff you do not have. These are the questions that decide whether you can run it.
Costs
What a QMS costs a small pharmaceutical company
Four costs, with published figures. The license is the one vendors quote and the smallest of the four.
Validation
What QMS validation involves
The documents, the sequence, and the one fact about responsibility that decides everything else.