Compliance, Quality and International Standards

Committed to patient safety and data integrity

At Verifarma, we develop technological solutions that meet the highest international quality, regulatory and information security standards.
Every system, process and operating flow is designed to ensure reliability, traceability and regulatory compliance in every market.

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Trust built globally

Audits and international presence

Our clients have been successfully audited by more than 10 international health authorities, including:

ANMAT (Argentina)

EMVO (Europe)

INVIMA (Colombia)

ISP (Chile)

COFEPRIS (Mexico)

ANVISA (Brazil)

MSP (Uruguay)

ARCSA (Ecuador)

FDA (USA)

Hand wearing a transparent glove holding a petri dish with blue bacterial culture.

Certifications and standards that support our platform

GS1 compliance

Global identification, traceability and communication standards.

GS1 standards adopted since 2008.
GS1 approval in 2013 for EDI documents.
Application of GTIN, SSCC, DataMatrix codes and global traceability structures.

EMVO Certification

Official recognition by the European Medicines Verification Organization.

Third company to obtain EMVO certification.
Ready to operate under the European drug verification and serialization scheme.

ISO 9001:2015 — Quality Management

Certification granted by TÜV Rheinland.

Processes aligned to ISO 9001:2015.
Strict compliance with 21 CFR Part 11.
Culture of continuous improvement and regular internal audits.

ISO 27001:2022 — Information Security

Certification approved by TÜV Rheinland.

Robust Information Security Management System (ISMS).
Risk management, business continuity and cryptographic controls.
Data encryption, controlled access and permanent monitoring.

FDA 21 CFR Part 11

Full compliance with Food and Drug Administration requirements.

Control of electronic records and electronic signatures.
Guaranteed integrity, authenticity and availability.
Validated compliance for regulatory audits.

EU Annex 11

European requirements for computerized systems in the pharmaceutical industry.

Complete validation of the software under European guidelines.
End-to-end data, history and traceability control.

COMPLIANCE & VALIDATION

How we ensure compliance in every process

Our approach is designed to ensure regulatory compliance, data integrity and patient safety. Each implementation is based on key pillars that allow it to operate under international standards and respond to highly regulated environments.

Data Governance and Security

Comprehensive information protection
‍Encryption in transit and at rest.
Redundant backups and disaster recovery.
24/7 monitoring and incident response.

Access Management
‍Strong Authentication (MFA).
Permissions by Role (RBAC).
Full system audit (Logs and audit trails).

Software validation and documentation

Validation methodology
‍Based on international standards:
URS (User Requirements Specification)
FS (Functional Specification)
IQ (Installation Qualification)
OQ (Operational Qualification)
PQ (Performance Qualification)

Customer Success as a compliance policy

‍One-day ticket resolution (average: 2 hours).
24/7 support in English and Spanish.
90% of calls answered in less than 45 seconds.
‍Ongoing monitoring.
Accompaniment in regulatory audits.
Documentation updated and available on demand.

Declaration of Commitment

‍Patient safety is our mission
‍Our entire technology ecosystem is designed to ensure reliable traceability, data integrity and regulatory compliance at every stage of the pharmaceutical process.