The batch record writes itself as the batch runs
Ninety-six control points, validated in live pilot runs with pharmaceutical manufacturers. The batch record writes itself as the batch runs, quality is the gate rather than the review, and the audit pack is a download because the evidence was never scattered. Validation-ready for 21 CFR Part 11, EU Annex 11 and Revised Schedule M, with ISO 27001 in progress, and kept current with regulatory change as part of the product, at no extra cost.
Schedule M stopped being a deadline and became an inspection
For two years Revised Schedule M was something to prepare for. It is not any more. The deadline for manufacturers above ₹250 crore passed in June 2024, the conditional extension for everyone below ended on 31 December 2025, and state drug controllers have been filing monthly inspection reports to CDSCO since November 2025. There is no turnover band left with a grace period.
What Schedule M asks for is not a document exercise. Pharmaceutical quality system, quality risk management, product quality review, lifecycle validation, computerised system controls and data integrity are continuous obligations, and they are only continuous if the system produces them as a by-product of the work. Assembling them in the fortnight before an inspection is the thing the regulation was written to stop.
The controls below run on the same compliance engine every industry uses.
What's tailored for pharmaceuticals
Not just compliance mapping — here's where the modules themselves work differently for this industry.
eBMR and eBPR execution — dispensing requires second-person verification, and line clearance blocks the next stage until the previous one is closed.
In-process results attach to the stage that produced them, with out-of-specification and out-of-trend investigation routed automatically.
Quarantined material is structurally refused at the point of dispensing — the control is the system, not a label on a drum.
Calibration blocks the stage the moment it lapses, instead of surfacing weeks later as a batch-level finding.
20 controls, 6 standards
Select a standard to filter
Working draft, not a certified mapping — our own reading of each framework's published scope, not a legal determination.
Coverage by geography
We watch the regulations so you don't have to
Standards don't stay still. The Compliance Engine tracks every one that applies to you: when a rule changes, it tells you what it affects, updates the system, and re-validates before anything goes live. You don't file a change request. It's already handled.
Schedule M pack shipped ahead of enforcement
Facility segregation, quality risk management and computerised systems controls were built into the rule set and validated before the phased deadlines landed, not after.
Revised Schedule M enforcement
No grace period across every turnover band, with state drug controllers reporting inspections monthly to CDSCO.
EudraLex Volume 4 Annex 11 & new Annex 22
Chapter 4 on documentation and Annex 11 on computerised systems, alongside a new Annex 22 on artificial intelligence. Public consultation closed in October 2025, and the pack follows the revisions into the product as they land.
Every update runs through the same validation discipline as the platform itself — tested against the workflows it touches before it reaches a single client's floor. Nothing ships because a regulation changed; it ships because the change passed.
Validation readiness
The controls above are enforced in the architecture, not configured on top of it.
- Validation packs (URS, IQ, OQ, PQ, RTM, GAMP 5) are available on the Dedicated tier.
- ISO 27001 certification is in progress.
- Inspection readiness is scored continuously by the Compliance Engine, not assembled the week before an audit.
For the technical detail behind these controls — encryption, access control, audit trail mechanics and backups — see Infrastructure & Security. For what sits in each workspace, see Modules.
Have a compliance requirement to walk through?
Tell us about your regulatory environment and we'll show you exactly how Factro fits.