Onboarding of new laboratory equipment
Onboarding of new lab equipment, especially the initial qualification is a critical process that ensures the proper installation and functionality of laboratory equipment, validating their suitability for use in scientific experiments and analyses. This qualification process typically involves a series of documented procedures and tests to verify that the equipment meets predefined specifications and regulatory requirements.
During initial qualification, attention is given to factors such as accuracy, precision, and reliability. This process not only establishes a baseline for the equipment’s performance but also lays the foundation for ongoing maintenance, calibration, and compliance with industry standards. A well-executed initial qualification ensures the integrity of laboratory data, contributes to the reliability of experimental outcomes, and upholds the quality and credibility of scientific research.
Our team takes ownership of the entire onboarding process and provides continuous support to the customer throughout. In addition to possessing compliance and technical skills, our team members approach their tasks on a project basis, ensuring the equipment achieves a qualified status through dedicated efforts.
Software validation with focus on data integrity
In the life science industry, especially within GxP environments, software validation is crucial for maintaining data integrity. Software systems play a vital role in various processes, including manufacturing, quality control, and regulatory compliance. The validation process is designed to assess and document every facet of these systems, encompassing aspects such as accurate data entry, secure storage and retrieval, processing reliability, and protection against unauthorized access.
Our team performs an assessment of the equipment software, ensuring its alignment with regulatory requirements. Furthermore, they collaborate with IT or related parties during the commissioning process, ensuring the proper configuration of the software in accordance with data integrity requirements. Ultimately, our team completes the validation of the software, adhering to an approved protocol to affirm its compliance and reliability.
In use qualification activities
Equipment that have successfully passed initial qualification must undergo periodic retesting to ensure ongoing compliance with regulatory standards as they progress through their operational lifespan. This proactive approach, known as in-use qualification, involves executing pre-approved procedures and protocols at regular intervals. These systematic and well-defined activities are designed to assess the continued reliability, accuracy, and adherence to established standards of the instruments in active use.
Our dedicated team possesses extensive hands-on technical experience across a spectrum of analytical techniques, ensuring a thorough understanding and proficient execution of in-use qualification activities to uphold the highest standards of quality and regulatory compliance.
Change management
Throughout the lifecycle of equipment, adjustments are often necessary to maintain compliance, varying from straightforward relocations to intricate configuration changes. These modifications are precisely documented in an event management system and executed following established procedures and protocols, ensuring that the equipment continues to meet regulatory requirements.
Our accomplished team brings valuable experience to the table, adeptly coordinating and planning complex changes from initiation to completion, and overseeing their seamless implementation. This involves a thorough understanding of regulatory standards, meticulous adherence to procedures, and a commitment to ensuring that all changes align with both regulatory requirements and operational necessities.
Lab equipment qualification
Onboarding of non-GxP lab equipment
Beyond the onboarding of GxP laboratory equipment, we offer assistance in onboarding non-GxP equipment as well. This involves setting up the equipment with the right configuration, establishing the requested data flow, and ensuring accurate labeling to facilitate seamless integration into the laboratory environment.
Data integrity support
In the rapidly evolving landscape of technology, ensuring robust data integrity support is essential. We go beyond by offering assistance in setting up the data flow, integrating crucial elements like data backup, and skillfully overseeing user access management as part of our services.
Master data management
Within a GxP environment, establishing a controlled process is essential to ensure an accurate and standardized inventory of laboratory equipment. To verify the accuracy of your lab equipment portfolio, we offer assistance in master data management. Our support encompasses validating correct equipment configurations and maintenance setup, including calibration plans, to maintain precision and compliance in your laboratory equipment park.
Planning and coordination of maintenance and calibration activities
Leveraging our extensive experience in planning and coordination, we are well-equipped to offer assistance in organizing and follow-up of maintenance and calibration activities.
Onboarding of non-GxP lab equipment
Beyond the onboarding of GxP laboratory equipment, we offer assistance in onboarding non-GxP equipment as well. This involves setting up the equipment with the right configuration, establishing the requested data flow, and ensuring accurate labeling to facilitate seamless integration into the laboratory environment.
Data integrity support
In the rapidly evolving landscape of technology, ensuring robust data integrity support is essential. We go beyond by offering assistance in setting up the data flow, integrating crucial elements like data backup, and skillfully overseeing user access management as part of our services. Recognizing the critical nature of data integrity, our team is well-equipped to navigate the complexities of contemporary technological advancements, safeguarding the seamless flow and security of your data assets.
Master data management
Within a GxP environment, establishing a controlled process is essential to ensure an accurate and standardized inventory of laboratory equipment. To verify the accuracy of your lab equipment portfolio, we offer assistance in master data management. Our support encompasses validating correct equipment configurations and maintenance setup, including calibration plans, to maintain precision and compliance in your laboratory equipment park.
Planning and coordination of maintenance and calibration activities
Leveraging our extensive experience in planning and coordination, we are well-equipped to offer assistance in organizing and follow-up of maintenance and calibration activities.
Lab operations
way of working
