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.
Guides
What a quality system costs, what validating one involves, and how to choose one when you have no IT department.
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.
What a QMS costs a small pharma company
Four costs, with published figures. The license is the one vendors quote and the smallest of the four.
What QMS validation involves
The documents, the sequence, and the one fact about responsibility that decides everything else.