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Industries

Pharmacies and laboratories

A vaccine refrigerator that spends the night at 11 °C gets found in the morning, when it's too late to do anything. Friolink alerts you as it happens and keeps the record the inspector will ask for.

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What usually goes wrong

  • Overnight power outages with nobody on site
  • Doors left ajar after restocking
  • Manual logs that are incomplete or filled in from memory
  • Temperature excursions nobody can explain

How Friolink helps

  • Continuous loggingA reading every few minutes, stored with date, time and unit.
  • Audit trailEvery alarm acknowledgment is signed by the user who handled it.
  • Reports by periodExport each refrigerator's history for the technical director or the inspector.
  • Pharmacy chainsEach branch sees its own units. Headquarters sees all of them.

Applicable regulations

  • European Union

    GDP 2013/C 343/01

    Good Distribution Practice for medicinal products for human use: controlled, monitored and recorded storage conditions.

  • United States

    21 CFR Part 11

    Trustworthy electronic records and signatures: controlled access, data integrity and audit trail.

  • United States

    USP <1079>

    Good storage and transportation practices for drug products, including temperature monitoring and excursion management.

  • Brazil

    ANVISA RDC 430/2020

    Good Distribution, Storage and Transportation Practices for medicines, as amended by RDC 653/2022.

  • Argentina

    ANMAT Disp. 2069/2018

    Good Distribution Practices for medicines, with temperature control and recording during storage and transport.

Friolink produces the records and alerts these regulations require. Compliance also depends on each company's processes and validation.

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