Pharmaceutical Analytics Installation and Operation Qualification (IQ/OQ)

Installation Qualification (IQ) and Operational Qualification (OQ) services aim to ensure that your instrument meets the manufacturer's design specifications for performance through thorough verification and documentation.

• IQ (Installation Qualification): Generate documented evidence and verification that the instrument has been delivered and installed according to the manufacturer's specifications
• OQ (Operational Qualification): Offers documented verification that the instrument subsystems are operating as designed, validating that the instrument's functionality meets the manufacturer's operational specifications
• Re-qualifications (OQ): Designed to confirm that the instrument continues to operate as specified by the manufacturer. These are typically performed annually after the initial IQ and/or OQ, or according to the user's SOP requirements, offering ongoing documented verification of performance.

Qualifications (IQ/OQ) are essential for laboratories operating within a quality management system, complying with global standards such as GLP, GCP, GMP, ISO 17025, and ISO 15189, or adhering to country-specific regulations like US FDA 21 CFR Part 11, CLIA, and CAP. These qualifications provide documentation that laboratory instruments are installed and operating according to the manufacturer’s performance specifications. Conducting these tests independently can be complex, time-consuming, costly, and challenging.

A well-planned and scoped qualification service offers greater flexibility compared to reactive measures taken due to non-compliance. By documenting that instruments and equipment are functioning correctly and producing high-quality data, qualifications provide peace of mind. They are crucial for every laboratory, even those not operating in a regulated environment.

Our IQ/OQ qualification services encompass comprehensive testing of your instrument system using verified tests, certified tools, and established performance standards. Whether you need IQ, OQ, or requalification, our services aim to deliver audit-ready documentation that can be presented to your regulating or certifying body, validating that your instrument operates within the manufacturer’s design specifications.

Regular testing of instruments is essential to maintain high-quality performance and to detect potential issues arising from normal use or component failure.
 

Service events include:

• At installation
• After relocation
• Following system additions, changes, or upgrades
• Post planned maintenance (PM)
• After critical repairs
• For scheduled OQ site requirements
• Before using a previously installed system in a regulated test environment for the first time

Thermo Fisher Scientific's instrument qualification services offer documentation solution, featuring rigorously tested protocols executed by certified field service engineers. These services include:

• Experienced technical support: Our trained and certified field service engineers (FSEs) possess extensive knowledge of Applied Biosystems and Invitrogen platforms. They undergo rigorous technical training at our global training centers and receive field support from professionals in R&D, manufacturing, and technical assistance centers (TAC). When serviced by our certified engineers, you can feel confident that your instruments meet Applied Biosystems and Invitrogen specifications.
• Increased uptime: Our experienced FSEs are ready to perform Thermo Fisher qualification protocols tailored to your instrument. These services typically take less than one day to complete, helping to minimize laboratory start-up time or downtime after repairs or scheduled maintenance, allowing your lab to resume production quickly.
• Cost-effective compliance: Our qualification services offer a predictable expense for your laboratory, reducing the time and costs associated with in-house technical resources for documenting instrument performance. This supports compliance without burdening your team.