Computer Systems Validation & Regulatory Compliance

We ensure full compliance with comprehensive solutions in validation, data integrity, information security governance, and quality management.

Validation of Computerized Systems

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We develop and document the System Validation Strategy, considering business processes, regulatory requirements, and the specificities of your environment.

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We map processes and perform a critical risk analysis ("Risk-Based Approach"), identifying vulnerabilities, prioritizing resources, and increasing validation effectiveness.

Complete development and execution of IQ, OQ, and PQ protocols. We perform all necessary testing to ensure system reliability, compliance, and security.
Generation and review of URS, FS, and DS
Functionality, security, and traceability testing
Documentation of deviations and treatment of nonconformities

IT Infrastructure Qualification

Asset Mapping

Detailed inventory of IT assets, classifying systems, equipment, and their interfaces for criticality and impact analysis.

Server, Network, and Database Qualification

Execution of qualification protocols, ensuring a secure, complete, and GxP-compliant environment.

Performance Testing

Assessment of performance, availability, redundancy, and data recovery testing to minimize failures and cyber risks.

Equipment Qualification

Laboratory and Production Equipment

Qualification of critical equipment for clinical, quality control, and production laboratories, strictly adhering to GMP standards.

On-demand documentation and protocols

Execution & Integration

Execution of qualification protocols based on risk analysis. Integration with validated LIMS and ERP systems, optimizing audit readiness.

ALCOA+ Controls

Implementation of policies and mechanisms that meet integrity requirements: data is Attributable, Readable, Contemporary, Original, Accurate, Complete, Consistent, Durable, and Available.

Electronic Records and Monitoring

Verification of systems, electronic records, and digital signatures. Monitoring of audit logs to analyze potential risks or tampering.

Data Integrity

Protect your critical data with ALCOA+ controls, fully compliant with FDA 21 CFR Part 11 and EMA Annex 11.

Audits

Internal and Supplier Audits

Complete regulatory diagnostics of your environment
Audits for supplier and third-party qualification

Simulations and Preparation

Simulation of ANVISA, FDA, and EMA audits
Gap analysis, corrective action plans, and team training for real inspections

Risk Governance and Information Security

Identification, classification, and prioritization of the organization's cyber and operational risks.

Development of policies and procedures that ensure compliance with ISO 27001, LGPD, GDPR, RDCs and International Good Practice Regulations (FDA, EMEA, PIC/S, WHO).

We carry out internal audits, prepare for ISO 27001 certification and implement Business Continuity Plans (BCM), ensuring the resilience and security of operations.

Trainings

We empower your team to ensure performance, compliance, and regulatory risk reduction.

Systems Validation

Practical training in Computerized Systems Validation, from strategy to execution.

Data Integrity

Training in ALCOA+, compliance requirements and best practices for integrity and traceability.

Information Security

Ensure a culture of digital security and data protection in the routine of all employees.

We ensure your company is ready for inspections, preventing non-compliance and potential regulatory issues!

Secure, compliant, and ready to integrate with your ecosystem

Built to connect with your existing stack while keeping governance, traceability, and control at the center.

Recognized Platform

An award-winning platform recognized by customers

Trusted by users and rated across leading software review platforms for value, usability, and support.

Global Thinking with Local Service

SoftExpert's global presence, with operations on every continent, drives its growth by delivering strong, personalized service tailored to each local market.