Validation and Qualification: Building assurance in radiopharmacy systems
29/09/2025
LabLogic’s qualification services allow sites to validate their products in accordance with regional regulations
Adopting new software, migrating to an electronic platform, or introducing new instrumentation can be challenging. Validation work can be lengthy, complex, and labour-intensive. Qualification plays a vital role in overcoming these challenges by ensuring that software and instruments perform reliably, safely, and in compliance with regulatory standards.
Qualifying systems worldwide
With extensive experience qualifying systems worldwide, LabLogic has the necessary knowledge to set up new systems and ensure they function as intended to deliver consistent results in real-world environments. LabLogic has developed comprehensive scripts and support material which are tried and testing in the field, standing up in highly regulated environments. Our validation services include on-site visits by an experienced team and through this guided approach, LabLogic helps deliver confidence and long-term assurance.
Software Installation Qualification
LabLogic provides SIQ to verify that purchased software has been correctly installed in the appropriate environment. This process ensures that all required system files, drivers, and dependencies are in place to support proper functionality. It also confirms that the software launches successfully and that users can log in, establishing a solid foundation for subsequent qualifications.
Instrument Installation Qualification
For instruments purchased from LabLogic, IIQ confirms that the instrument has been physically installed according to its specifications. This qualification detects any installation issues that could affect functionality and prepares the instrument for further qualifications such as OQ and PQ.
For instruments connected to PETra or SPECTra LIMS software, IIQ will verify that the instrument is correctly set up and connected. Tests confirm that PETra or SPECTra can import data from the instrument and display it correctly within a Batch or Production Session.
Operational Qualification
LabLogic provides OQ that tests software and hardware operate as intended under defined conditions. This qualification verifies that performance requirements are met and highlights issues such as bugs or incompatibilities. Evidence is captured through audits, screenshots and reports, demonstrating compliance with regulatory and quality standards.
Performance Qualification
Working in collaboration with the end user, LabLogic develops bespoke PQ services to qualify that the software and equipment consistently perform as expected under real-world operating conditions. This process provides assurance that the system can reliably deliver expected results during routine use to support long-term quality assurance and performance.
Find out more
If you’d like to know more about our qualification and validation services, click the button below to speak to a product specialist directly.