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Pharmaceutical & Medical Devices

Labeling & Identification Inspection for Pharmaceutical & Medical Device Manufacturing

Company Overview

NorrSpect, based in Umeå, Sweden, is a pioneer in AI-powered solutions for high-precision manufacturing. With experience supporting some of Europe’s leading production companies—including Volvo Cars—NorrSpect applies its deep expertise in industrial AI and computer vision to regulated sectors like pharmaceuticals and medical devices.

NorrStudio, their flagship AI inspection platform, is built to meet the exacting standards of life sciences manufacturing, delivering intelligent and adaptive quality control for labeling and identification processes.

Sector Challenge: Labeling & Identification Compliance

In pharmaceutical and medical device production, labeling is not just a packaging step—it is a critical component of product safety, regulatory compliance, and traceability. Errors or inconsistencies in printed information can lead to misdosing, recall risk, or import/export delays due to non-compliance with global regulations such as GS1, UDI, and 21 CFR Part 11.

Traditional vision systems often lack the flexibility to adapt to new label formats, languages, or curved surfaces. NorrStudio solves these limitations with deep learning-driven inspection tailored to dynamic labeling environments.

Use Case Focus: Labeling & Identification Inspection

Below are key defect categories NorrStudio addresses on pharmaceutical and medical device lines.

1. Barcode Illegibility (GS1/UDI)

Challenge: Barcodes—especially DataMatrix or UDI codes—may be smudged, incomplete, or poorly contrasted, leading to scan failures.

Solution: NorrStudio uses AI-driven decoding and pattern recognition to verify barcode readability under diverse lighting and surface conditions.

Impact: 100% barcode verification for downstream traceability and global compliance.

2. Wrong Dosage Printed

Challenge: Incorrect dosage printing on packaging or leaflets can result in serious patient harm or legal exposure.

Solution: NorrStudio’s OCR engine reads and verifies dosage text against reference data or ERP system outputs.

Impact: Elimination of dosing misinformation before product release.

3. Label Skewed on Curved Surfaces

Challenge: Labels applied to cylindrical items (vials, syringes, ampoules) often shift or warp during application.

Solution: Computer vision models trained on curved geometry analyze label orientation and adhesion in real time.

Impact: Reduction in packaging waste and improved visual consistency.

4. Serial Number Mismatch

Challenge: Serialized products must have unique identifiers matching internal databases and printed records.

Solution: AI vision systems capture and cross-verify serial numbers against batch data or MES systems.

Impact: Full alignment between digital records and physical units for global serialization standards.

5. Incorrect Language or Region Labeling

Challenge: Products exported to multiple countries must have region-specific languages and regulatory markings.

Solution: NorrStudio inspects for correct language layouts, font structure, and compliance symbols using multilingual OCR and template matching.

Impact: Prevented customs hold-ups and market-specific mislabeling.

6. Faded Ink on Expiry Print

Challenge: Low-quality or fading ink on expiry dates can cause rejections at distribution or retail level.

Solution: Adaptive contrast analysis ensures print darkness and legibility meet validation thresholds across label types.

Impact: Reduction in rejected shipments due to unreadable expiry dates.

Why Choose NorrStudio?

  • AI OCR & Pattern Matching: Reads, verifies, and classifies all printed data with high reliability.

  • Works on Any Surface: From flat cartons to transparent syringes, curved vials, and foil pouches.

  • Compliant by Design: Supports GS1, UDI, 21 CFR Part 11, EU MDR, and ISO 13485 standards.

  • Connected to Systems: Integrates with MES/ERP for serial number and label validation.

  • Automated Logging: Image-based documentation and audit trails for quality assurance teams.

Customer Outcomes

  • 98% Reduction in labeling-related rework or recall risk

  • Full Compliance with global serialization and identification standards

  • 30% Faster QA Signoff thanks to real-time label verification

  • Traceable Audit Logs for every unit scanned and verified

About NorrSpect

With headquarters in Umeå, Sweden, NorrSpect is a leader in industrial AI, serving top-tier manufacturing clients across Europe. The company combines deep learning, computer vision, and domain-specific knowledge to deliver scalable and intelligent inspection systems—empowering manufacturers to meet tomorrow’s quality standards today.

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Ready to Transform Your Business with NorrStudio?

Take the next step toward smarter automation, better customer management, and data-driven decisions.

NorrSpect.se

Ready to Transform Your Business with NorrStudio?

Take the next step toward smarter automation, better customer management, and data-driven decisions.

NorrSpect.se

Ready to Transform Your Business with NorrStudio?

Take the next step toward smarter automation, better customer management, and data-driven decisions.

NorrSpect.se