eQMS regulation guides, mapped clause by clause
These guides map the eQMS regulatory requirements of seven regulations, clause by clause: what each one asks, the QMSdesk™ control that supports it, the evidence that control produces, and what stays yours to own. Every guide comes with a checklist and is re-checked against primary sources every quarter.
Electronic records and signatures
21 CFR Part 11In force26 requirementsThe FDA's rule for electronic records and electronic signatures, mapped section by section, from §11.10 controls to §11.300 identification codes and passwords.EU GMP Annex 112011 text in force, 2025 revision in draft18 requirementsThe EU's GMP guideline for computerized systems: the 2011 text in force, and what the July 2025 draft revision would change for cloud services, supplier agreements, audit trails and security.Medical devices
FDA QMSRIn force16 requirementsThe Quality Management System Regulation, in force since February 2, 2026. It incorporates ISO 13485:2016 by reference and changes how FDA inspects.ISO 134852016 edition18 requirementsThe medical device quality management standard, clause by clause, with the records QMSdesk keeps for each.Pharmaceutical quality systems
ICH Q10ICH guideline13 expectationsThe pharmaceutical quality system model: CAPA, change management, management review and monitoring, and why CAPA and change are peer systems.Validation and new technology
Computer Software AssuranceFinal FDA guidance9 principlesThe FDA's final guidance on risk-based assurance for production and quality management system software, and what it means for validating an eQMS.EU GMP Annex 22Draft12 expectationsThe EU's proposed GMP annex on artificial intelligence, and why QMSdesk keeps every regulated decision with a person.01
From regulation to configuration
QMSdesk's twelve regulatory profiles turn these regulations into the way your system runs: the event types you record, the roles that sign, the deadlines you keep and the retention floors you meet. Hold more than one, and the strictest rule wins.
Find the regulations that apply to your sector on each industry page.
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Kept current
Regulations move. Every page in this guide is reviewed by Abdul Azam, Founder & CEO, who has 25 years in regulated life-sciences quality, and is re-checked against primary sources every quarter. Each page shows its last-reviewed date.
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Your compliance, your evidence
QMSdesk is designed to support these requirements. Compliance itself is established in your environment, for your intended use, and our validated core platform and your written validation scope show you exactly where our part ends and yours begins. See how validation works.
eQMS regulations FAQ
Which regulations apply to an eQMS?
It depends on what you make and where you sell. Electronic records and signatures fall under 21 CFR Part 11 in the US and EU GMP Annex 11 in the EU. Medical device makers answer to the FDA QMSR and ISO 13485. Pharmaceutical quality systems follow ICH Q10. QMSdesk's twelve regulatory profiles turn the ones you work under into the way your system runs.
What is the difference between 21 CFR Part 11 and EU GMP Annex 11?
Part 11 is an FDA regulation on electronic records and electronic signatures. Annex 11 is EU GMP guidance on the whole life of a computerized system used in GMP work, including risk management, suppliers, validation and periodic evaluation. If you sell into both markets, you work to both. See them side by side.
Are the revised Annex 11 and the new Annex 22 in force?
No. Both were published as drafts on July 7, 2025, and as of September 24, 2026 neither has been adopted. The 2011 Annex 11 remains the version in force.
Can software take care of regulatory requirements for us?
Software can supply the controls, and your organization supplies the procedures and the evidence of use. QMSdesk is designed to support these requirements, and every guide's last column says what stays yours to own.