Validation support, built in.
No pharma QA team buys a monitoring system it cannot validate. Abhilekh is designed so your computerized system validation is a documentation exercise on solid evidence — not an archaeology dig.
Evidence, not assurances
Everything your validators need to see is designed to be demonstrated, not asserted.
Validation protocols ship with the product
Abhilekh is not a black box at validation time — the compliance core (checksum-chained records, e-signatures, audit trails) is designed against 21 CFR Part 11 expectations and its validation protocols ship with the product.
A risk-based, GAMP-aligned design
The platform follows a risk-based approach familiar to QA teams: identified critical functions (record integrity, alarm delivery, access control) are engineered controls with documented behaviour, not SOP-dependent promises.
Documented, testable behaviour
SHA-256 checksum chains, on-device immutable audit partitions, RBAC + MFA, and per-tenant isolation are all testable claims — your validators can verify integrity behaviour directly, not take it on faith.
Audit-ready outputs
One-click PDF/Excel reports with excursions, audit trails, e-signatures, and per-device calibration status give inspectors the evidence format they expect — cryptographically signed, so the document an inspector holds can be verified against the record it came from.
IQ · OQ · PQ, mapped to the platform
A standard three-phase qualification, with Abhilekh controls and documentation at each step.
The system is installed and configured as designed — connectivity, device provisioning, tenant setup, and integrations verified against documented specifications.
The platform is challenged across its operating envelope — alert rules, excursion and MKT detection, e-signatures, audit-trail integrity, report generation, and calibration flagging.
Your processes run on your data — monitoring your sites with your thresholds, proving the complete workflow produces inspection-ready records under real conditions.
Deployment-specific qualification protocols, test scripts, and acceptance documentation are scoped with your QA team per deployment — ask us for the validation pack structure during evaluation.
The proof-of-concept numbers, published
Every figure is a recorded test run or verification artefact in the product repository — the same evidence your validators walk through. Capabilities still being verified (first physical hardware, on-target firmware) are labelled as in validation, not advertised as finished.
The full status table — what is live and tested, what is in validation, what is roadmap — ships with evaluation. Current design-stage evidence includes generated enclosure fit-checks passing 791/791 checks across all 20 SKUs and 20/20 SKU configurations booting under Renode emulation. Device-level detail is in the ABH range overview (PDF) and the platform capability brief (PDF).
In regulated use, the operating company — not the vendor — owns the validation conclusion for its computerised systems. Abhilekh’s role is to make that conclusion defensible: protocols that ship with the product, testable integrity controls, and documented behaviour for every critical function. We support your validation effort; you sign the summary report with confidence.
Bring your QA team to the demo
We'll walk through integrity controls, protocols, and the qualification approach using a deployment shaped like yours.