Industries · Healthcare & pharma

From 21 CFR Part 11 to DPDP, one control plane

GxP validation, 21 CFR Part 11 and DPDP patient-data obligations governed with the same rigour, across every site that must stay inspection-ready.

What the regulator expects

Healthcare and pharma answer to GxP inspectors and, for patient data in India, the DPDP Act. Computerised systems, records and signatures are examined; personal data obligations are continuous.

How Compli-Once answers

GxP as first-class frameworks

21 CFR Part 11, EU GMP Annex 11, WHO GMP and PIC/S run with the same control, evidence and audit tooling as your security standards.

DPDP for patient data

Consent and processing obligations modelled control by control, sharing evidence with your security programme where it applies.

Multi-site by design

Hospital chains and plant networks run as scoped entities under one tenant, each with its own posture, rolling up to group.

Frameworks, mapped together

One control implementation feeds every framework above. Adopt the next mandate and the crosswalk shows your existing coverage before you plan a single task.

Frequently asked questions

Can GxP and security frameworks share evidence?

Yes. Where a control serves both a GxP requirement and ISO 27001, the evidence is stored once and linked to both, with validity tracked in one place.

How are multiple sites managed?

Each site runs its own registers and framework scope under the group tenant. Site posture computes independently and rolls up to a group dashboard.

You're done. We're not.

The audit ends. The readiness doesn't. See it on your own data.