Združljivo označevanje, ki bo spremenilo vaše poslovanje

Proizvajalci medicinskih naprav se soočajo z vedno večjimi pritiski pri doseganju skladnosti. Zahteve UDI agencije FDA se že nekaj časa veljavne v ZDA, hitro pa se razvija tudi uredba za medicinske naprave v Evropski uniji (EU MDR), ki vključuje podobne zahteve.

NiceLabel offers a next generation label management system that enables UDI compliant labeling and empowers medical device manufacturers (MDMs) to digitally transform their business. By undergoing this transformation, MDMs are able to increase agility while reducing operational costs.

Learn how digitally transforming your business can give you the competitive advantage in a challenging marketplace.

Prenos bele knjige

Diapozitiv1

Life science companies who have transformed their labeling

  • Lina
  • Ultradent
  • Krka
  • Sanofi
  • Arla Foods
  • Abbott logo
  • Sonova
  • Nuvasive
  • Sorin

Read our Life science case studies

Slide2

Complimentary webinar

Label Compliance and the New European Medical Device Regulations (MDR)

Learn what medical device manufacturers need to do to prepare for compliance, the benefits of implementing a label management system and how label verification and print quality inspection aid compliance.

Recorded webinar available

View the webinar here

Slide3

Digitally transform your operations with NiceLabel

NiceLabelov sistem za upravljanje etiket, LMS Enterprise, vam omogoči avtomatizacijo tiskanja etiket prek standardizirane integracije v sistem ERP, sistem za izvedbo proizvodnje (MES) in druge poslovne sisteme na posameznih mestih. S centralizacijo podatkov in vzpostavitvijo enotnega vira zaupanja vrednih podatkov, lahko odpravite napake pri ročnem vnosu podatkov, nepravilno označevanje in povezane stroške.

Integrirajte tiskanje etiket v sisteme MES in ERP

LMS Enterprise enables medical device manufacturers to use a single software platform for all printing devices and for all packaging and shipping, from primary to tertiary labeling. By digitizing your label production process, you can meet regulatory requirements faster, reduce labor costs, get products to market faster and avoid recalls related to labeling errors. The result will be a more agile manufacturing operation that will enable your company to meet current and future challenges and compete in an increasingly complex market environment.

Sistem za upravljanje dokumentov, ki omogoča enostavnejše izpolnjevanje zahtev po skladnosti

LMS Enterprise includes a document management system (DMS) that was built for regulatory labeling. It’s a centralized digital label catalog that controls and streamlines label lifecycle management by providing role-based access, document versioning, configurable approval workflows, and electronic records and electronic signatures (ERES) which are necessary to conform to FDA and EU regulations. A graphical “label comparison” tool helps consolidate label template variations and provides added quality assurance.

Elektronski zapisi in revizijske sledi več kot le izpolnjujejo zahteve pravilnikov v bioznanostih.

LMS Enterprise provides a comprehensive set of audit trails, including full traceability and visualization of every printed label. Traceability extends beyond printing to include every change request and system event, including user, location and timestamp information. Additionally, electronic PDF documents reflecting physically printed labels, can be natively generated for submission to 3rd party content management or PLM solutions.

Sistem za spremembe in transport za bioznanosti

LMS Enterprise se skorajda neopazno integrira v tipično večnivojsko IT-okolje proizvajalcev medicinskih naprav ter vključuje sistem za spremembe in transport, ki ponuja nadzorovano in enostavno spodbujanje sprememb v različnih okoljih, kot je razvojni oddelek, oddelek zagotavljanje kakovosti in proizvodnja.

Explore our label management system

Slide4

Študija primera

How LiNA Medical used UDI compliance as an opportunity to digitally transform their labeling

Prenesite študijo primera

Slide3

Digitally transform your labeling processes to capitalize on market opportunities

By digitally transforming your processes with the NiceLabel Label Management System (LMS Enterprise), you will:

  • Znižali stroške delovanja: krajša karantena, manj predelav, manj preklicev in bolj zadovoljne stranke.
  • Skrajšali čas do začetka prodaje: poslovni uporabniki se čutijo sposobni izvajati nadzorovane spremembe etiket brez pomoči IT-oddelka.
  • Izboljšali produktivnost in zanesljivost: odpravite ročna opravila, poenostavite upravljanje življenjskega cikla etiket in izboljšajte preglednost označevanja, da ustvarite bolj učinkovito in odporno dobavno verigo.
  • Strengthen collaboration and compliance: gain competitive advantage by digitizing and standardizing your label process, ensuring compliance and quality across teams, sites and external partners.

We're here to help you transform your labeling

NiceLabelov sistem za upravljanje etiket ponuja možnost konfiguracije in uvedbe prek skupine za strokovne storitve, kar zagotovi uporabo najboljših praks pri uvedbi in jo hkrati tudi pohitri. Ekipa PSG zagotavlja pakete skladnosti IQ, OQ in PQ ter storitve, ki vam bodo pomagale izpolniti potrebe po dokumentiranju in zahteve po skladnosti.

Izvedite več o izdelkih NiceLabel

Slide5

Learn more about medical device manufacturing’s digital transformation

Case Study

Pri podjetju za izdelavo medicinskih naprav so dosegli globalno skladnost s pravilniki in standardi, hkrati pa izboljšali natančnost in znižali stroške

Prenos študije primera

Bela knjiga

Priprava za FDA 21 CFR, del 11, in EU GMP, dodatek 11

Prenos bele knjige

Dental device manufacturing case study

Case Study

Globalni proizvajalec zobnih vsadkov je dosegel skladnost z označevanjem UDI in integracijo s sistemi Oracle

Prenos študije primera

Objava na blogu

Preverjanje skladnosti je vedno bolj pomembno za podjetja v bioznanostih

Preberite več

Objava na blogu

The Class II UDI deadline is past. Enterprise labeling is the future.

Preberite več

Objava na blogu

Kako se je srednje velik proizvajalec medicinskih pripomočkov odzval na nove predpise

Preberite več

Objava na blogu

Pravilnika EU MDR in IVDR sta bila odobrena. Kaj pa sedaj?

Preberite več