Computerized System Validation
for the Regulated Industry
Why is it essential to validate computerized systems?
In highly regulated sectors such as pharmaceuticals, biotechnology, and healthcare, computerized systems play a key role in ensuring data traceability, integrity, and regulatory compliance. Validating these systems is a fundamental requirement to comply with standards such as GMP, FDA’s 21 CFR Part 11, EMA guidelines, and GAMP 5—ensuring system reliability and data security.
Benefits of our validation service
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Guaranteed regulatory compliance
We ensure your systems comply with international standards (GMP, GAMP 5, 21 CFR Part 11, ISO 13485).
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Efficiency and optimization
We implement validated processes that improve business operations without disrupting productivity.
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Risk reduction
Avoid regulatory deviations and enhance data integrity and system security.
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Ongoing support
We provide continuous validation maintenance to ensure long-term compliance.
Ensure the compliance of your IT systems with our validation service. Meet GMP, FDA, and EMA standards while maintaining data integrity and operational efficiency.
Our computerized system validation service
We offer a comprehensive solution for the validation, implementation, management, and ongoing maintenance of computerized system validation. Our approach ensures that all applications and tools used in critical processes meet current regulatory requirements.
We validate all types of IT systems, including:
- Laboratory instruments
Ensuring data accuracy in clinical and pharmaceutical analyses. - ERPs (Enterprise Resource Planning)
Validating business systems to ensure integrity in production and administrative processes. - LIMS (Laboratory Information Management Systems)
Implementing controls to guarantee reliable laboratory data. - MES (Manufacturing Execution Systems)
Validating systems to optimize traceability and production quality. - Document management systems: Ensuring compliance in electronic document control for audits and regulatory processes.
- SCADA systems
Validating industrial control systems to ensure operational reliability. - Serialization systems
Validating pharmaceutical traceability platforms to prevent counterfeiting. - Clinical trial management systems (eTMF, CTMS, EDC, etc.)
Validating platforms for secure and efficient clinical study management.
