Expertise Validation & Testing Analytical Instrument Qualification

Analytical Instrument Qualification

Agidens understands the critical importance of compliance with regulations and industry standards in the life sciences sector. Our approach focuses on unburdening customers, making sure the analytical instruments at their facilities meet the highest levels of quality, safety and compliance. At the end, patient and consumer safety is a mutual goal.

Agidens is your partner for lab equipment and analytical instrument qualification, offering end-to-end support and expertise to ensure your operations are consistently reliable, accurate, and compliant. Our approach to qualification involves a meticulous process that covers every aspect of ensuring reliability and compliance. Among other services, we perform qualification according to regulations.


Full Life Cycle Support

Agidens supports you in creating and implementing a balanced maintenance plan that covers the entire Equipment Life Cycle. We start by creating an inventory of all equipment and assessing the risks and potential impact scenarios. We also help you review the Validation Master Plan and guide you in implementing Service Level Agreements with third parties.

With our Equipment Life Cycle Management Services, your laboratory will comply with the Code of Federal Regulations Title 21, Chapter 21C, Part 211. The documentation will also meet the requirements specified in CFR Title 21, Chapter 21C, Part 211, Paragraphs 180 and 182. For more information, visit chapter 21C part 211 and paragraphs 180 and 182.

In addition to taking care of your equipment, we can monitor its performance, cost of operations, cost of ownership, Mean Time Between Failures (MTBF), and Mean Time To Repair (MTTR). This provides you with an insightful view of your equipment’s functionality.


Agidens provides professional support throughout the life cycle of your lab equipment, ensuring it consistently meets the requirements of both external regulations and your specific needs.

Customized protocols and implementation

  • Guidance in selecting & purchasing
  • Accurate documentation according to applicable GDP rules
  • Development of tailored validation plans, including URS, risk analysis, testing and final report
  • Decommissioning support
Equipment Life Cycle Management
Life Sciences

Lab Qualification at major pharma site

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