Compliance
Designed for the standards you certify to
Not a compliance module beside the product - the signatures, the trail and the permissions run through every record in it.
Re-authentication and e-signatures on every regulated transition, with immutable audit metadata and reason-for-change capture.
Document control, supplier evaluation, training records, internal audits, CAPAs and risk - all mapped to ISO §§4-8.
Vigilance reporting (MIR for EUDAMED), FSCAs, FSN broadcast with a delivery ledger, and registration that feeds post-market surveillance.
The quality-management clauses, with an optional starter procedure set - load it as editable drafts, or bring the SOPs you already run.
The standards library holds whatever applies to you - ISO 27001, ISO 14001, a customer scheme - with clauses linked to the SOPs, audits and findings that satisfy them. No starter content required.
Cross-cutting
What an auditor will spend their time on
Wired through every module - not bolted onto specific ones.
21 CFR Part 11 e-signatures
Re-authentication and reason-for-change capture on every regulated transition. Three signature modes: internal, token-link for external signers, and paper-scan upload with an attesting signer.
Immutable audit trail
An append-only log on every write - who, when, from where, and the before and after. The trail is what an inspection reads.
WORM / write-once retention
Approved controlled-document files are locked under write-once retention for the configured window, so an approved revision cannot be silently overwritten or deleted.
Role-based access control
Standing roles with per-module permissions, set per person and per function. Viewer is read-only with no exceptions, and the backend is what enforces it.
Approval workflows with separation of duties
Each module carries its own states and transitions. Separation-of-duties checks are properties of a transition, enforced as the record moves.
Complete data isolation
Every company's data is separated from every other's, enforced in two independent layers so a single failure cannot cross the boundary.