Built for the frameworks that govern pharma.
Abhilekh was designed against 21 CFR Part 11, WHO PQS performance standards, and EU GDP expectations from the first architecture review — compliance is the foundation, not a reporting module.
Clause-by-clause mapping
How the platform's documented capabilities map to the FDA's electronic records and signatures rule.
| Part 11 requirement | How Abhilekh addresses it |
|---|---|
| § 11.10(a) — Validation | Risk-based, GAMP-aligned design; validation protocols ship with the product so your CSV dossier is built on documented evidence. |
| § 11.10(b) — Accurate & complete copies | One-click PDF and Excel reports with excursions, audit trail data, and per-device calibration status. |
| § 11.10(c) — Record protection & retention | Records are checksum-chained and retained for 5+ years, with on-device immutable logs surviving connectivity loss. |
| § 11.10(d) — Limited system access | Role-based access across system and tenant role sets; PostgreSQL Row-Level Security isolates every tenant. |
| § 11.10(e) — Authority checks & § 11.30 | Actions are gated by role; administrative access requires MFA; device connections use per-device credentials over TLS 1.2+ (X.509/mTLS on the roadmap). |
| § 11.10(k) — Audit trail | Every reading and user action enters a SHA-256 checksum chain — tamper-evident by construction, not by policy. |
| § 11.50 — Signature manifestations | E-signatures capture the signer's printed name, date/time, and meaning of the signature, authenticated with password + TOTP. |
| § 11.70 — Signature/record linking | Signatures are written into the same checksum-chained record they authorise — they cannot be excised or transferred. |
ALCOA+, by construction
The attributes inspectors probe for — enforced by the architecture rather than by SOPs alone.
Every action tied to an identity and role
Human-readable reports + structured exports
Event-time recorded at the device, chain-verified on ingest
On-device immutable log preserved as the source record
NIST-traceable calibration tracked per probe; drift flagged
WHO PQS & EU GDP
Continuous, documented, audit-ready monitoring for health-sector cold chain and medicinal-product distribution.
- Engineered to WHO prequalification performance standards for health-sector cold-chain temperature monitoring
- Continuous monitoring with excursion, duration, and MKT detection
- Battery-backed loggers keep recording through outages — no silent data gaps
- Continuous monitoring and documented evidence for storage and distribution of medicinal products
- Excursion reports with full audit trail and calibration status of every device in scope
- CAPA workflows to close the loop on deviations
Schedule M, CDSCO & NABL-calibration environments
Abhilekh is built in Gujarat by an in-house engineering team — and maps naturally onto what Indian GMP inspections ask for.
Schedule M (revised 2024)
India’s strengthened GMP expectations call for controlled storage conditions and traceable records. Abhilekh provides continuous monitoring with immutable, inspection-ready records across every storage point — from 2–8°C fridges to −80°C ULT freezers.
CDSCO-licensed operations
Inspections focus on documented evidence that stored product stayed in specification. Excursion reports, audit trails, e-signatures, and CAPA workflows give QA teams a defensible record per site, device, and batch.
Calibration traceability
NIST-traceable calibration certificates, due dates, and reminders are tracked per probe; expired or out-of-tolerance sensors are flagged before they put a batch at risk. Reports carry the calibration status of every device in scope.
Software is not “certified” against 21 CFR Part 11 or EU GDP by any registrar — compliance is assessed per implementation, by the regulated company, on documented evidence. Abhilekh is engineered for these frameworks and ships validation protocols with the product so your QA team can build its own validation dossier. Where a mark is a genuine third-party certification (e.g. hardware CE/FCC), we list it only when held — our hardware compliance targets are labelled as targets until then.
See the compliance core on your cold chain
Book a walkthrough focused on your frameworks — Part 11, WHO PQS, EU GDP, or Schedule M — using a pharma use case like yours.