NABH compliant IVF software helps a fertility clinic keep the records, access controls and traceability an accreditation assessment looks at. Today, general NABH hospital accreditation is what applies. NABH has also released a draft accreditation standard written for ART clinics, first edition 2025, and it is still a draft. Vitrify maps its record keeping, access control and traceability to the requirements in that draft.
NABH TODAY
A fertility clinic that seeks NABH accreditation today does so under the general NABH hospital accreditation standards. There is not yet a finished accreditation scheme for ART clinics. What exists is a draft: NABH has released a draft ART clinic accreditation standard, first edition 2025. Until it is final, its wording can still change, so clinics should read it as a clear signal of direction rather than as rules already in force.
Among its chapters, the draft covers the Information Management System (IMS) and Care of Patients (COP). Those two chapters hold the requirements that clinic software touches most directly. They ask for medical records with a unique identifier and entries that are chronological, dated, timed and attributable. They ask for retention in line with national and state law, for authentication, access control and automatic log-off, and for a tested programme for planned and unplanned downtime. They ask for patients, donors, recipients, gametes and embryos to be identified with at least two unique identifiers, and for gamete and embryo data to be reported regularly to the National ART and Surrogacy Registry.
None of this depends on the draft becoming final. A clinic that already keeps attributable records, limits clinical records to care providers and tracks every gamete and embryo with two identifiers is already keeping the records these requirements describe, whichever way the final standard settles. Accreditation is awarded to the clinic, not to its software. What software does is produce the evidence an assessment asks for as the work happens, so it is ready when the clinic needs it.
RECORD INTEGRITY
Under IMS.1 of the draft, every medical record carries a unique identifier, and each entry is chronological, dated, timed and attributable to the person who made it. Records are retained as national and state law requires (IMS.1e). For ART clinics in India, the ART (Regulation) Act 2021 requires records to be kept for at least 10 years (s.23).
Vitrify supports structured record keeping with long retention and an audit trail, so each entry carries its time and its author and the record holds together over the full retention period.
ACCESS AND CONFIDENTIALITY
IMS.4a of the draft asks for authentication, access control and automatic log-off, with clinical records limited to care providers. IMS.2c asks for a tested programme for planned and unplanned downtime.
Role-based access control in Vitrify limits each record to the people who provide care, and the audit trail shows who opened it. Data is kept secure, and planned downtime handling supports the downtime programme a clinic tests.
TRACEABILITY
COP.1d of the draft asks a clinic to identify patients, donors, recipients, gametes and embryos with at least two unique identifiers. COP.8c asks for multi-layered documentation, traceability and confidentiality for gamete and embryo samples.
Vitrify supports electronic witnessing and gamete and embryo traceability with unique identifiers, so each sample can be followed from its source through every laboratory step.
REGISTRY REPORTING
COP.8f of the draft asks for regular reporting of gamete and embryo data to the National ART and Surrogacy Registry. This sits alongside the reporting duties in the ART (Regulation) Act 2021, explained in our guide to ART Act 2021 compliance.
Vitrify supports export and reporting for the National ART and Surrogacy Registry, drawn from the records the clinic already keeps.
HOW SOFTWARE MAPS
Each requirement in the draft lines up with a capability a clinic can look for in its software. These are the ones Vitrify provides.
Structured record keeping with an audit trail.
Structured records with long retention.
Role-based access control and an audit trail.
Secure data with planned downtime handling.
Electronic witnessing and gamete and embryo traceability with unique identifiers.
Gamete and embryo traceability with role-based access control.
Export and reporting for the National ART and Surrogacy Registry.
See how this works in the EHR and EMR, lab management and cryo storage. For the legal duties behind Registry reporting, read our guide to ART Act 2021 compliance.
FAQ
Short answers on where NABH stands for fertility clinics and how software fits.
KEEP EXPLORING
Start from the Vitrify home page, browse every module on the products hub, find the setup that fits your clinic on the solutions hub or compare plans on pricing. Related reading: ART Act 2021 Compliance for IVF Clinics in India, the IVF clinic software guides and IVF software in India.
