NexIndu
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NexInduEN
CMMS for GxP plants
Maintenance management with records that survive an audit
NexIndu manages work orders, preventive maintenance, inventory and shift handovers in regulated plants. Every record is signed, timestamped in plant time and protected by an immutable audit trail.
- Electronic signatures with identity re-verification on every closure
- Immutable audit trail with record-by-record hash chaining
- Immutable plant-time date and time on every operation
- modules on one shared traceability core
- 8modules on one shared traceability core
- languages for plants with multinational teams
- 6languages for plants with multinational teams
- regulatory frameworks mapped requirement by requirement: 21 CFR Part 11 and EU GMP Annex 11
- 2regulatory frameworks mapped requirement by requirement: 21 CFR Part 11 and EU GMP Annex 11
- hard deletes: critical records are flagged, never removed
- 0hard deletes: critical records are flagged, never removed
A day of work on the floor with NexIndu
Five everyday maintenance moments — and what gets recorded in each one.
When every record is born audit-ready, inspections stop being an event
NexIndu structures daily operations so compliance is not a separate chore: it is the natural by-product of doing the work.
01 · Record
Everything is written down in the moment
Work orders, interventions and handoffs are recorded in plant time, with an identified author and drafts that never get lost.
02 · Control
Every action has an owner and a signature
Per-person roles and permissions, electronic signatures with identity re-verification, and a chain of custody on every shift handoff.
03 · Prove
The evidence is already there
An immutable audit trail with chained hashes, KPIs that open the exact list they come from, and reports ready for the inspector.
- Record 12803f9a…c21eprev 0000…0000
- Record 1281b7d4…08aaprev 3f9a…c21e
- Record 128291ce…f5d0prev b7d4…08aa
- Record 12836a02…7b93prev 91ce…f5d0
- Record 1284e4f1…2c6dprev 6a02…7b93
- Chain intact
Verifiable compliance, requirement by requirement
Every regulatory requirement is answered with a concrete technical control you can verify in the system. This is the short version.
StandardRequirementControl in NexIndu
21 CFR Part 11 §11.10(e)Secure, computer-generated, time-stamped audit trailAppend-only audit log: the database rejects updates and deletes, and every event is hash-chained to the previous one.
21 CFR Part 11 §11.50 + §11.70Electronic signatures with meaning, linked to their recordEach signature requires re-verifying a password or biometrics and stores the signer, meaning, date and a permanent link to the signed record.
EU GMP Annex 11 §9Recording of changes and deletions of critical dataCritical records are never physically deleted: they are flagged as removed and the change is written to the audit trail.
EU GMP Annex 11 §12Access controls for the system and its dataIndividual accounts with roles and permissions, and per-organization isolation enforced row by row in the database itself.
ALCOA+ · AttributableEvery data point has an identified authorEach record stores who created it, who modified it and who signed it. There are no shared accounts.
ALCOA+ · ContemporaneousData recorded at the time of the operationTimestamps are set by the server in the plant's declared time zone and cannot be edited afterwards.
Nexi: natural-language search with clear limits
Nexi answers questions about your plant's history using the work orders, guides and documents already in the system. It is designed for regulated environments.
- Personal data is masked before any query is sent to an external model.
- Every answer cites the internal sources it comes from.
- AI spend has a monthly budget with a hard cap and per-call usage logging.
Built for regulated industries
The same traceability core, applied to each sector's regulatory framework.
Pharmaceutical
- FDA 21 CFR Part 11
- GMP
- ANMAT
Food and beverage
- ISO 22000
- HACCP
- SENASA
Medical devices
- ISO 13485
- FDA QSR
- CE
Chemical and industrial
- REACH
- ISO 9001
See NexIndu with your plant's own cases
A 30-minute demo with your real scenarios: work orders, preventive maintenance, audit trail and shift handovers.