Compliance and security, built in.
HAROM India is designed for the standards that matter in drug safety — and for the security enterprise buyers require. Controls are designed in, not bolted on.
Designed to support 21 CFR Part 11 and EU Annex 11 controls.
Built for the standards that matter
We describe the frameworks our platform and services are built and aligned for. We state what we adhere to — never claim certifications we don't hold.
ICH E2B(R3) & CIOMS
Built for the international electronic case standard and standard case forms used by regulators worldwide.
GVP modules
Aligned to EU Good Pharmacovigilance Practices, including the modules for literature (VI) and signals (IX).
21 CFR Part 11
Trustworthy electronic records and signatures, with the controls the FDA rule expects.
GAMP 5
Systems built and documented for validation in regulated environments.
Global regulators
Support for EMA/EudraVigilance, FDA, MHRA, Health Canada, CDSCO and WHO expectations.
How we protect your data
A high-level view of the controls that keep your data safe. (We don't publish architecture detail.)
Encryption in transit & at rest
Your data is protected with strong encryption both while stored and while moving between systems.
Access controls & 2FA
Role-based access and two-factor authentication ensure only the right people see the right data.
Automatic audit trails
A complete, tamper-evident record of who did what and when — the traceability inspectors expect.
Controlled systems
Systems are controlled and documented so they behave predictably and hold up under inspection.
Fast where it should be. Human where it matters.
AI and automation remove the repetitive work; qualified experts stay in control of every safety-critical decision; and the system records everything automatically.
Automation does the heavy lifting
Automation and AI handle the repetitive work — validations, checks, coding assistance and first-pass drafting.
Expert reviews & approves
Qualified PV professionals review and approve every safety-critical decision. Nothing reaches a regulator without human sign-off.
System records
A complete, tamper-evident audit trail captures who did what and when — traceable and inspection-ready.
Compliance preserved
Designed to support ICH, GVP and 21 CFR Part 11 controls — by design.
Frequently asked questions
Questions about compliance or security?
Our team is happy to walk through the standards we're built for and how we protect your data.
Ready