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.
LAB EQUIPMENT & ANALYTICAL INSTRUMENT QUALIFICATION
Our experts are well-versed in a wide range of different brands and models of analytical equipment used in various laboratories. They work towards developing an efficient maintenance plan specifically designed to meet your needs, balancing cost management and equipment availability. Understanding the complexity of laboratory work, our experts collaborate with you to ensure flawless execution.
Lab Assessments
Our experts conduct thorough assessments in different domains to identify and address any gaps in compliance and efficiency within your laboratory environment.
- GxP assessments
- Data Integrity and ALCOA assessments
- 21 CFR part 11
- Annex 11
- Compendial ( EP, USP, JP, …)
- ISO 17025 assessments
- Lean lab assessments (value stream mapping)
Equipment Introduction
Our services include all activities required for the introduction of your Equipment.
- Equipment Selection & Purchase
- Change control
- Validation Plan
- Risk Assessments
- User Requirement
- Protocols IQ, OQ, PQ (incl. Execution)
- Release Reports
- Planning and Project Management
Services
We offer a range of services to meet your needs
- Managed Service Team (MST) is a team at the customer’ site that provides a full package service.
- Scope-based projects
- Engineers to support existing processes or teams
Day-to-Day Life Cycle Activities
Our services go further than introducing new equipment. We support customers in there day-to-day activities in the life cycle of equipment.
- Change control
- CAPA
- Resolution of Deviations
- Writing SOP and WI
- Audit Support
- Periodic Review
- Decommissioning of equipment
Training
We support you in training. Our experts are available to provide training initiatives on different topics at the customers’ site or in one of our facilities on different topics.
- Data Integrity
- AIQ (Analytical Instrument Qualification)
- Compendia
- CSV (Computer System Validation)
- GDP & ALCOA
CSV
Is your equipment connected to an integrated data system? Agidens supports the validation of software and the connections to your equipment.
- CSV & DI
- LIMS
- LAB X
- CDS systems (Empower, Chromeleon …)
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.
THOROUGH EQUIPMENT VALIDATION PROCESS
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
Lab Qualification at major pharma site
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TAKE YOUR ANALYTICAL INSTRUMENT QUALIFICATION TO THE NEXT LEVEL
Do you like our approach? We would love to hear from you!
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