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Regulatory compliance

Ready for inspection.

Friolink covers what HACCP, ANMAT, SENASA, MSP and ANVISA require from a temperature monitoring system. Here it is, standard by standard: what they ask for and how we handle it, in plain language.

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Standard by standard.

What each standard requires from a monitoring system, and what Friolink does to cover it.

Food · all countries

HACCP

Codex Alimentarius CXC 1-1969 · Argentine Food Code, art. 18 bis

What it requires

  • Monitor each critical control point against a defined limit.
  • For every deviation, a corrective action with the cause, the person responsible and what was done with the product.
  • Records verified by someone other than the person who monitors.
  • Records with company, location, date, time, product, batch and signature, kept at least for the product's shelf life.

How Friolink covers it

  • Continuous 24-hour measurement, with the critical limit set as the equipment's range.
  • Handling an alarm records who, when, the cause, the action and what happened to the product.
  • Periodic signed record review, with the option to stop whoever handled the alarms from signing it.
  • HACCP report in PDF with product, batch, sensor location, alarms and signatures. 5-year retention, up to 10.

Pharmacies, distributors and logistics operators · Argentina

ANMAT

Disposition 2069/2018 · Good Distribution Practice for medicines

What it requires

  • Temperature mapping of areas and equipment, with sensors placed according to that mapping.
  • Continuous recording with devices calibrated at least once a year by an accredited laboratory.
  • An effective alarm system, tested periodically and recorded; if it fails, a daily max/min check.
  • Records verified by responsible staff, and changes that never erase the original data.
  • A validated computerised system, with access for authorised staff only and backups. Records kept at least 2 years.

How Friolink covers it

  • Temperature mapping study with the warmest and coldest points, approved with a signature (areainfo performs the study as a service).
  • Readings every 1 to 10 minutes and calibration certificates per probe with expiry warnings.
  • Alarm tests per channel with signature; if the alarm is out of service, the device page asks for each day's min and max.
  • Signed record review and a change audit trail with old value, new value and reason.
  • Baseline validation package, per-site permissions, two-factor login, encrypted daily backup and 5-year retention by default.

Animal and plant products · Argentina

SENASA

Argentine Food Code, art. 18 quater · cold rooms

What it requires

  • A measuring system the authority can check at any time.
  • The sensor at the warmest point of the cold room.
  • Records of maximum and minimum temperature, and humidity where applicable.

How Friolink covers it

  • A QR code per device showing its live status, no login required.
  • The device page stores where the sensor is and whether it is the warmest point according to the mapping.
  • Min and max per period in the history and in the reviews; humidity with its own threshold.

SENASA's specific requirements vary by sector; we review them with each customer.

Medicines and food · Uruguay

MSP

Ministry of Public Health · National Food Regulation

What it requires

  • For medicines, good storage and distribution practice with temperature and humidity mapping studies.
  • For food, keeping each product within its temperature range and being able to prove it.
  • Records available and alarms when deviations occur.

How Friolink covers it

  • Temperature mapping and temperature and humidity sensors in every cold room, fridge or warehouse.
  • Ranges per device and continuous recording, with min, max and time out of range.
  • Notifications via app, email, WhatsApp, Telegram and monitoring centre, with escalation.

Medicines and food · Brazil

ANVISA

Good distribution and storage practice for medicines and for food services

What it requires

  • Temperature monitoring and recording in storage and distribution.
  • Mapping of areas and qualified equipment.
  • Records that can be presented to the health inspection.

How Friolink covers it

  • Continuous recording with alarms and documented corrective action.
  • Temperature mapping and per-probe calibration with certificate and expiry.
  • Verifiable PDF reports, history and CSV export.

Pharma and laboratories · used by ANMAT and ANVISA as a reference for electronic records

21 CFR Part 11 · Annex 11

FDA 21 CFR Part 11 · EU GMP Annex 11

What it requires

  • A secure, time-stamped, system-generated audit trail that cannot be altered.
  • Electronic signature with name, date, time and meaning, linked to what is signed.
  • Data that is attributable, legible, contemporaneous, original and accurate.
  • Access for authorised people only, and a validated system.

How Friolink covers it

  • Chained audit trail: each event is linked to the previous one, so any alteration shows.
  • Signature with password or two-factor code and its written meaning, with a fingerprint of the signed content.
  • Tamper-proof readings with synchronised server time and a verifiable daily seal.
  • Roles per site and module, lockout after failed attempts and a validation package (description, risks, IQ/OQ/PQ).

What Friolink does and what your company does.

No software replaces the HACCP plan or the responsible pharmacist. Friolink takes care of recording, alarms and evidence; the rest belongs to each establishment.

Friolink

  • Measures temperature and humidity 24/7 and keeps readings even if the internet goes down.
  • Notifies and escalates until someone responds, and records the corrective action.
  • Requires an electronic signature for reviews, alarm tests and alarm handling.
  • Seals the readings every day and logs every change with its reason.
  • Tracks calibration expiry dates and pending alarm tests.
  • Produces the HACCP report, the CSV and each device's QR code.
  • Keeps 5 years (up to 10), with an encrypted daily backup.
  • Provides the system's baseline validation package.

Your company

  • Writes the HACCP plan and sets the critical limit for each cold room.
  • Appoints the responsible pharmacist (for medicines) and the people in charge of monitoring and verification.
  • Writes the procedures and decides what to do with the product after a deviation.
  • Places the sensor at the warmest point and keeps a max/min thermometer.
  • Has the probes calibrated once a year by an accredited laboratory.
  • Has a generator or alternative power source and maintains the cooling equipment.
  • Trains staff to respond to an alarm.
  • Runs and approves the on-site system qualification (IQ/OQ/PQ).

On inspection day.

Everything they will ask for comes out of Friolink in minutes.

  1. 1

    Open the HACCP report for the period. It carries a verification code the inspector checks online.

  2. 2

    Show the period's alarms with cause, action, product outcome and signature.

  3. 3

    Show the signed reviews, the alarm tests and, if applicable, the approved temperature mapping.

  4. 4

    Show the valid calibration certificates for each probe.

  5. 5

    If they ask for raw data, export the CSV. The daily seal proves nobody touched the readings.

Regulatory compliance is the responsibility of each establishment; Friolink provides the records and controls these standards ask for.

Let's talk.

Tell us your sector and which standards apply to you. We'll show you what your inspection report looks like.

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