Part 11 guides
13 guides in 4 subjects
These guides read the regulation the way an inspector does: what the text says, which records it reaches, and what you would be asked to show. Each one is written from the regulation itself and FDA's own guidance documents, in plain words, for a lab or device maker without a validation department.
New to the rule? Start with what Part 11 is and who it binds. Writing a gap assessment? Go to the requirements, section by section.
Signatures and records
5 guides Signatures and records hub
- 21 CFR Part 11: what it is and who it binds17 min read
What 21 CFR Part 11 covers, which records and signatures it reaches, who it binds, and what a Part 11 compliant claim on software can mean.
- 21 CFR Part 11 requirements, section by section19 min read
Each Part 11 requirement in plain words, from the § 11.10 controls to the § 11.300 password rules, with what an inspector asks to see.
- What is an audit trail (in GxP)?10 min read
What a GxP audit trail must capture, how long it is kept, and what separates a trail that holds up in an inspection from one that does not.
- EU Annex 11 for US labs and device makers14 min read
What EU GMP Annex 11 asks of computerised systems, when a US lab or device maker has to meet it, and how it differs from Part 11.
- ALCOA+ principles of data integrity15 min read
ALCOA and ALCOA+ one attribute at a time: what FDA and PIC/S say, how each looks on paper, in a system and in a spreadsheet, and the classic failure.
Validation
4 guides Validation hub
- Computer system validation (CSV) for small labs17 min read
The CSV lifecycle sized for a small lab: requirements, risk, IQ, OQ and PQ, the report and periodic review, and what goes in the pack.
- CSA vs CSV: what changed12 min read
CSA vs CSV side by side: what FDA's 2026 CSA guidance changes, what it leaves alone, and one quality system planned both ways.
- What is GAMP 5?15 min read
GAMP 5 in plain words: what ISPE's guide is for, its life cycle, the software categories by name, and how it sits with Part 11, CSA and Annex 11.
- Excel spreadsheets under Part 1114 min read
When an Excel spreadsheet can hold GxP data under Part 11, the controls it needs, and when to move the calculation into a system.
Quality systems
2 guides Quality systems hub
- What is GxP?16 min read
GxP explained for small labs and device makers: GLP, GCP, GMP, the device QMSR and GDP, the records each requires, and where 21 CFR Part 11 applies.
- FDA QMSR for small device makers13 min read
The FDA QMSR took effect on February 2, 2026: what 21 CFR 820 now holds, what FDA added to ISO 13485, where Part 11 fits, and a 90-day plan.
Part 11 software
2 guides Part 11 software hub
- What is a LIMS (and when is it Part 11 ready)?12 min read
What a LIMS records in an R&D or GMP lab, how it differs from an ELN, and the features it needs before Part 11 records live in it.
- 21 CFR Part 11 for cloud and SaaS systems18 min read
How Part 11 applies when your records live in a vendor's cloud: supplier qualification, shared responsibility and what to ask the vendor.