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 |
|---|---|---|---|
| Revised Schedule M (GMP), Drugs Rules 1945 cdsco.gov.inPharma & life sciencesOfficial CDSCO copy: Gazette of India Extraordinary No. 738, 28 Dec 2023 (Hindi and English PDF, 272 pages). | India | Revised good manufacturing practice requirements notified as G.S.R. 922(E) on 28 Dec 2023, including controls for computerised systems and records. | Computerised-system access control, audit trails, data integrity and validated-state security. |
| New Drugs and Clinical Trials Rules, 2019 cdsco.gov.inPharma & life sciences | India | Rules for new drugs, clinical trials, bioavailability and bioequivalence studies in India, including ethics committees and record-keeping. | Secure trial data handling, access governance, vendor and site oversight. |
| 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. |
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.
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