GAMP® 5 (Good Automated Manufacturing Practice) is a globally recognized guideline for ensuring the quality, reliability, and compliance of automated systems in regulated industries like pharmaceuticals. It follows a risk-based approach, lifecycle management, and collaboration with system suppliers to ensure that systems are fit for their intended use while maintaining data integrity and compliance.

For pharmaceutical trials, where precision and reliability directly impact patient safety and research outcomes, GAMP® 5 provides a framework to:

• Streamline the validation of trial management systems.
• Minimize risks associated with data integrity.
• Ensure compliance with regulatory requirements such as FDA 21 CFR Part 11 and EMA Annex 11.

Vilintra solutions with GAMP® 5 for pharmaceutical trial management:

Precision, compliance, and efficiency are non-negotiable. With global regulations becoming increasingly stringent and clinical trials growing in complexity, adopting robust frameworks is a necessity. Vilintra, leverages the principles of GAMP® 5 to offer support in conducting research and clinical trials.

Clinical research with GAMP® 5 compliance

Vilintra’s Pharmaceutical All in One Solution is designed with GAMP® 5 principles at its core, ensuring that every aspect of clinical trial management aligns with global best practices.

1. Risk-based validation

GAMP® 5’s risk-based approach ensures that functionalities of Vilintra’s PTMS are validated to prevent potential failures. By prioritizing risk assessment, Vilintra identifies:

• Data accuracy and integrity.
• Document management and storage.
• Data leakage, GDPR compliance.
• Upholding regulatory standards.

Processes remain reliable and trustworthy, safeguarding patient data and trial outcomes.

2. Lifecycle management

Solutions evolve alongside advancements in technology and changes in regulatory expectations. From initial system design and implementation to ongoing operation and eventual decommissioning, Vilintra focuses on maintaining the highest levels of compliance, functionality and data safety.

This lifecycle perspective provides system robustness, so that researchers can rely on consistent performance throughout the research and trial process.

3. Centralized and scalable solutions

With GAMP® 5’s lifecycle activities, Vilintra’s PTMS covers the needs of trials of all sizes and complexities. Centralized data storage and integration of trial activities support collaborations and scalability for multi-site and multi-national studies.

4. Data integrity and compliance

Data integrity is a cornerstone of both GAMP® 5 and Vilintra’s Solutions. By leveraging advanced automated systems, Vilintra:

• Eliminates manual data entry errors.
• Automates audit trails for transparency.
• Secure, tamper-proof data management.

These features align with GAMP® 5’s focus on science-based quality risk management, helping trial teams maintain regulatory compliance.

GAMP® 5 within Vilintra solutions

Streamlined collaboration

GAMP® 5 leverages supplier involvement, and Vilintras platform connects research teams into collaborations. Researchers can securely access, update, and share information in real time, operating with accurate, up-to-date data.

Increased productivity and faster results

By automating tasks such as document creation, regulatory tracking, and data cleaning, Vilintra’s PTMS aligns with GAMP® 5’s goal of optimizing workflows. This not only reduces administrative burdens but also accelerates trial timelines, bringing therapies to market faster.

Clinical research in progress

Currently, Vilintra is involved in over 300 clinical trials, all of which are ongoing. The platform’s adherence to GAMP® 5 principles ensures compliance and operational efficiency.

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