Plain-English guides for regulated teams.
What the rules actually ask for, and practical ways to meet them, written for quality, lab and operations people rather than lawyers.
All guides
21 CFR Part 11 in plain English
What FDA's rule on electronic records and electronic signatures actually requires, clause by clause, what's on your software vendor and what's on you, with a checklist.
Validation · 3 minComputer Software Assurance in practice
FDA's Computer Software Assurance guidance in plain terms: the four steps, how to decide what's high risk, which testing fits, what records to keep, and a worked example for a configurable quality system.
Regulations · 3 minThe Annex 11 revision: what's changing
The draft revision of EU GMP Annex 11 on computerised systems: its status, the main changes (identity and access, audit trails, suppliers and cloud services, security), and a gap checklist to start now.
How-to · 3 minMoving quality records off SharePoint and Excel
A practical plan for moving controlled records off SharePoint lists and spreadsheets: why teams outgrow them, how to pick the first process, migrate the data, keep the history, and validate the switch.
How-to · 3 minBuilding a CAPA process that works
How to set up corrective and preventive action: what goes into a CAPA, the steps from problem to effectiveness check, the records auditors look for, and the mistakes that lead to observations.
Guides are general information, not legal or regulatory advice. Regulations and guidance change: check the current text.