Excellence in Technical Qualification

Qualification and Validation that Ensure Compliance and Safety

Experts in sterilization processes, thermal mapping, and regulatory compliance. Complete solutions for pharmaceutical transportation and dentistry.

Leading Reference in Qualification and Validation in Brazil

For over 15 years, Biologger has been delivering technical excellence to companies seeking regulatory compliance and safety in their critical processes.

With nationwide operations, Biologger is a reference in thermal qualification, equipment validation, and regulatory consulting. We serve pharmaceutical industries, logistics carriers, dental clinics, and hospitals across Brazil.

Our team comprises specialized engineers and technicians with extensive experience in ANVISA regulations, RDC 430/2020, RDC 653/2022, RDC 15/2012, and FDA 21 CFR Part 11. We use RBC-calibrated instruments and cutting-edge software to ensure tamper-proof data and conclusive reports.

FDA 21 CFR Part 11 Compliant
+15
Years of Experience
+500
Clients Served
+3,200
Qualified Equipment
+4,800
Reports Issued

Areas of Expertise

Specialized solutions for sectors that demand the highest compliance and safety standards.

Transportation Qualification

Thermal mapping of refrigerated vehicles, compliance with RDC 430/2020 and RDC 653/2022, route qualification, and continuous temperature monitoring.

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Dental Sterilization

Autoclave validation, IQ/OQ/PQ per ISO 17665, thermal mapping of equipment, and reports for Health Surveillance (RDC 15/2012).

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Complete Qualification Solutions

From initial assessment to conclusive reports, we provide all the technical support your company needs.

Equipment Qualification & Validation

Installation (IQ), Operational (OQ), and Performance (PQ) qualification for autoclaves, ovens, cold chambers, and other critical equipment.

Thermal Mapping

Temperature and humidity mapping in vehicles, equipment, and storage areas. Detailed reports with statistical analysis and charts.

Regulatory Compliance Reports

Complete technical documentation per FDA 21 CFR Part 11, with tamper-proof data, digital signatures, and full traceability.

Why Choose Biologger?

Technical excellence combined with innovation and commitment to compliance.

Cutting-Edge Software

Advanced systems for data collection, analysis, and qualification management.

RBC-Calibrated Instruments

All equipment certified and traceable by the Brazilian Calibration Network.

Tamper-Proof Data

Electronic records with audit trail and protection against unauthorized changes.

Conclusive Reports

Complete, clear technical documentation ready for audits and inspections.

Frequently Asked Questions

It is the documented process that demonstrates equipment or environment operates within specified parameters. Includes sensor installation, data collection, statistical analysis, and conclusive report issuance.
Annual qualification is recommended, or whenever significant maintenance, repairs, or changes occur to the equipment or process.
Qualification demonstrates equipment is fit for use (IQ, OQ, PQ). Validation demonstrates the production process consistently delivers results within specifications.
Yes. RDC 15/2012 requires health services to prove sterilization process effectiveness. Autoclave qualification with technical reports is a key requirement.
Typically 5 to 15 business days, depending on vehicle complexity, number of sensors, and requirement for summer and winter condition mapping per RDC 653/2022.

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Get a personalized proposal for your company. Our technical team is ready to assist you.

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Get in Touch

We are ready to help your company achieve the compliance and safety you need.

Contact Information

Our team is available Monday through Friday, 8am to 6pm.

Headquarters — São PauloRua General Góis Monteiro, 660 – sala 01 – Pompéia
ZIP: 05029-000 — Tel: +55 (11) 2924.2404
Branch — São José dos CamposAv. Lisboa, 53 – Jd. Augusta
ZIP: 12216-630 — Tel: +55 (12) 92000.1137
Emailcontato@biologger.com.br

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