Computerised systems, covered clause by clause
The operational controls Annex 11 expects from software are built into the platform — and it produces the audit trails, signatures and records your validation package and SOPs point to.
Data
Built-in checks on every electronic exchange — typed validation, scale tolerance and calibration gating, strict factory scoping.
Accuracy checks
Critical manual entries need a second operator: the verifier must differ from the weigher and signs electronically.
Printouts
Clear, printable copies of every batch record, with signatures and their verification state on the page.
Audit trails
System-generated, append-only trail of every change with user, timestamp, before/after values and the reason.
Security
Role-based access per module and factory, failed-login lockout, password aging — and every authorisation change recorded.
Incident management
Deviations and CAPAs with revision-controlled investigations, root cause and effectiveness verification.
Electronic signature
Signatures are timestamped and cryptographically bound to the record's content — tampering after signing fails verification.
Batch release
Release demands an explicit e-signature from an authorised person, recorded on the batch with identity, date and time.
Archiving
Records are retained, never hard-deleted, and content-hash signatures keep archived data verifiable for integrity.
Annex 11 is a lifecycle standard: risk assessments, validation packages, backups and change-control procedures remain your quality team’s responsibility. Smart Factory supplies the enforced controls and inspection-ready evidence they build on.
Stay audit-ready, always
Talk to us about how Smart Factory maps to your quality system and regulatory obligations.