Regulations & frameworks
Compliance that stands up to the regulator
Find the regime that applies to you and see how we help you meet it. Each name links to the official source.
| Regulation or framework | Region | What it covers | How we help |
|---|---|---|---|
| 21 CFR Part 11 ecfr.govPharma & life sciences | United States | FDA rules for electronic records and electronic signatures used in place of paper under FDA regulations. | Access control, audit trails, signature controls, validation support. |
| FDA CGMP data integrity guidance fda.govPharma & life sciences | United States | FDA's 2018 questions and answers on data integrity and compliance with drug CGMP. | Data integrity gap assessment, system controls, remediation plans. |
| FDA medical device cybersecurity (section 524B) fda.govPharma & life sciences | United States | Premarket cybersecurity expectations for cyber devices under section 524B of the FD&C Act, including vulnerability management plans and an SBOM. | Threat modelling, secure product development, SBOM and vulnerability handling processes. |
| HIPAA Security Rule hhs.gov | United States | Security safeguards for electronic protected health information held by covered entities and business associates. | Risk analysis, safeguards, business-associate controls. |
Descriptions are summaries to orient you, not legal advice. Links go to the publisher's page and may change. Check the current text and any amendments before relying on a requirement. NAPSECURE is an advisory firm and does not issue certifications or regulatory approvals.
Not sure which rules apply?
We will map your obligations and show the shortest path to evidence.