differentiated capabilities
Advanced Label Control
Advanced Label Control delivers end-to-end label lifecycle management natively within the MES — from design approval through print, scan reconciliation, and eDHR capture — purpose-built for medical device, aerospace, and other highly regulated manufacturers where an incorrect label is a recall event.
Request DemoThe Problem
Why label control is a compliance minefield
In medical device manufacturing, a labeling error is not a quality escape — it is a regulatory event. FDA 21 CFR Part 820 and ISO 13485 mandate that labels are approved, version-controlled, reconciled, and traceable throughout the device history record. Most manufacturers manage this through external labeling systems disconnected from MES execution, creating integration gaps, reconciliation blind spots, and audit vulnerabilities.
RECALL Risk
Labeling issues account for 8–10% of all FDA medical device recalls. Industry-wide, 35–40% of all product recalls are attributed to packaging and labeling errors — making it one of the highest-frequency root causes in regulated manufacturing.
483 OBSERVATIONS
“Labeling and packaging operations not controlled to prevent mix-ups” is a named recurring FDA 483 citation. Device-related Form 483s nearly doubled FY2021–FY2022 (191 to 538), intensifying scrutiny on label version control and e-signature evidence.
TRANSLATION FAILURES
EU MDR Article 10(11) mandates labels in the official language of every Member State where the device is sold — up to 24 languages. Non-compliance triggers recalls, market withdrawal, and importer financial liability under Articles 13–16.
INTEGRATION GAPS
External print servers create a data seam — labels printed outside MES context break eDHR completeness. FDA 483s consistently cite DHRs that do not include or reference a UDI, a direct consequence of disconnected print governance.
How it works
End-to-end label lifecycle inside Eyelit MES
Label Design
BarTender .btw + fields
Version controlled
Label Data
Product-specific data
Multilingual translations locked
E-Sig Approval
Holistic approval of
design + data combination
Print Execution
Operator image verify
BarTender rendering
Reconciliation
Print / scrap / reprint count reconciliation enforced
eDHR Audit Trail
Rendered label image stored Full inspection-ready record
Compliance coverage
Built for regulated manufacturing across sectors
Regulatory frameworks addressed
Advanced Label Control is designed to satisfy the label approval, e-signature, traceability, and reconciliation requirements across the regulated industries Eyelit serves.
21 CFR Part 820 / QMSR
820.45 (QMSR, 2024) mandates documented label control procedures, accuracy inspection prior to release, and records of labeling release per ISO 13485 Clause 4.2.5. Operations must prevent mix-ups.
21 CFR Part 11
Every label approval action must be gated by e-signature linked to the electronic record, with a secure time-stamped audit trail of print events. Records must be tamper-evident and retained for inspection.
ISO 13485:2016
Clause 7.5.1(e) explicitly requires defined operations for labeling and packaging as part of production control. Clause 4.2.5 mandates documented release records for all labeling prior to use.
EU MDR 2017/745
Annex I, Chapter III mandates multi-language label content per Member State. Article 10 requires UDI integration and post-market label traceability.
EU IVDR 2017/746
Equivalent labeling and language requirements for IVD products sold in the EU, including symbol-only labeling standards per ISO 15223-1.
Unique Device Identification
21 CFR Part 830 governs label content: every device label must carry a correctly formatted UDI-DI and UDI-PI (lot, serial, expiry) submitted to the GUDID database. EU MDR Article 24 mirrors this for EUDAMED.
Architecture — label governance at the point of execution
Label control is enforced inside Eyelit MES, not via a disconnected print server. The governance layer lives where the manufacturing data lives.
Label Print Service
On-premises agent coordinates Eyelit MES, BarTender, and the print queue. Data stays on the customer server.
Label Printing Software
BarTender (Automation or Enterprise) is embedded within Eyelit MES. Customers may alternatively integrate their own preferred label printing software.
Single Data Model
Label design, approval, print job, and eDHR record share one data model — zero synchronisation lag.
ERP / MES Native
Work order and item master data flows directly into label fields. No middleware. No re-keying.
ROI
Measurable compliance and operational value
Recall prevention
Approved-only print enforcement and full reconciliation eliminates the most common root causes of label-related FSCAs and Class II recalls.
Audit readiness
eDHR label records are complete, timestamped, and inspection-ready. Eliminates manual reconciliation spreadsheets and paper-based label logs.
Faster releases
Batch approval workflows for product families reduce QA time for label releases when a common template is updated across a wide range.
Reduced 483 risk
Addresses the FDA’s most-cited label control observations: missing e-signatures, absent version history, and unreconciled print quantities.
Label print can have an enormous impact on a business if not done correctly, especially when dealing with product labels. An incorrectly printed label could require a product range to be recalled at great expense — or cause irreparable damage to a brand.
– Eyelit MES Label Printing Training
Target verticals
Built for regulated manufacturers
Medical Device
FDA 21 CFR Part 820 & ISO 13485 label control. EU MDR multi-language enforcement. UDI traceability through eDHR. Class II / III device label governance.
Audit Aerospace & Defense
AS9100 Rev D label and part marking controls. Full serialization traceability. Counterfeit part prevention via reconciled label records tied to work order genealogy.
Pharma-Adjacent / IVD
GMP label control aligned with EU IVDR 2017/746. Expiry date and lot number governance via MES-driven SQL field sources. Translation lock prevents post-approval drift.
GET IN TOUCH
Ready to get started?
Label governance embedded in execution — not bolted on.
Resources
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