Attaining and maintaining a validated and qualified state of processes, systems, and components in a GxP (Good Practice) environment is critical, especially in highly regulated industries such as pharmaceuticals. In these settings, compliance with regulatory standards isn’t just a recommendation – it’s a legal and operational necessity. Vesdo recognizes this imperative and leverages its deep serialization expertise and extensive experience to ensure that all relevant requirements are met while optimizing the effort-benefit ratio for the specific application. 

The Vesdo Serialization Quality Management covers the following:

Computerized System Validation (CSV)

Computerized System Validation (CSV) is a critical component of ensuring that your serialization system is compliant with regulatory requirements and capable of consistently producing accurate, reliable results. Vesdo’s CSV services are designed to ensure that all computerized systems within your serialization environment, including hardware and software, are validated according to the strictest standards. Our validation process includes:

• Planning and Documentation: Development of a comprehensive validation plan that aligns with both regulatory standards and your operational requirements.
• System Testing: Rigorous testing of the system’s functionality, including input/output verification, error handling, and data integrity checks.
• Traceability: Establishing traceability from user requirements to testing to ensure that all system functionalities are verified and validated.

Qualification/Validation of Processes, Systems, and Components (IQ/OQ/PQ)

Qualification and validation are integral to ensuring that your serialization system, as well as its components, operate as intended and meet regulatory standards. Vesdo offers comprehensive qualification and validation services that include:

• Installation Qualification (IQ): Verifying that all equipment and systems are installed correctly and in accordance with design specifications.
• Operational Qualification (OQ): Ensuring that the system operates within predefined parameters and performs its intended functions under various conditions.
• Performance Qualification (PQ): Confirming that the system consistently performs as required during routine operations over a sustained period.

GxP Assessments

Good Practice (GxP) guidelines, which include Good Manufacturing Practice (GMP) and others, are designed to ensure that products are consistently produced and controlled according to quality standards. Vesdo conducts thorough GxP assessments to ensure that your serialization system and associated processes adhere to these guidelines. Our GxP assessment services include:

• Gap Analysis: Identifying any areas where your system may fall short of GxP requirements.
• Compliance Roadmap: Developing a detailed plan to address gaps and achieve full compliance.
• Continuous Monitoring: Establishing ongoing monitoring and review processes to maintain GxP compliance over time.

Functional Risk Assessment

In any serialization project, understanding and mitigating risks is crucial. Vesdo’s Functional Risk Assessment services are designed to identify potential risks in your serialization processes, systems, and components, and to implement strategies to mitigate those risks. Our approach includes:

• Risk Identification: Evaluating your serialization system to identify potential points of failure, vulnerabilities, and compliance risks.
• Risk Analysis: Assessing the likelihood and impact of identified risks, prioritizing them based on severity.
• Risk Mitigation: Developing and implementing risk mitigation strategies to reduce or eliminate risks, ensuring the stability and reliability of your system.

Why Choose Vesdo for Serialization Quality Management?

Vesdo’s deep knowledge of serialization, combined with its expertise in GxP environments, makes it the ideal partner for companies looking to implement or maintain compliant serialization systems. By focusing on the optimal effort-benefit ratio, Vesdo ensures that your serialization system not only complies with regulations but also enhances your overall operational efficiency.

Partnering with Vesdo means you’ll have access to a team of experts dedicated to ensuring that your serialization processes, systems, and components are validated, qualified, and compliant with all relevant GxP standards. Whether you’re in the planning stages or need ongoing support, Vesdo is here to help you achieve and maintain the highest levels of quality and compliance.