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.
Ensuring equipment reliability, accuracy and integrity throughout its lifecycle is crucial. That is why we have experts in different domains to assist you in meeting your goal.
OUR APPROACH TO LAB EQUIPMENT & ANALYTICAL INSTRUMENT QUALIFICATION
Agidens is your partner for lab equipment & 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 others, we perform qualification according to regulations.
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 …)
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
Read moreTAKE YOUR ANALYTICAL INSTRUMENT QUALIFICATION TO THE NEXT LEVEL
Do you like our approach? We would love to hear from you!
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Process & Cleaning Validation
Process validation guarantees a focus on patient safety, product quality, and data integrity for both producers and consumers. Moreover, Agidens offers guidance and assistance for cleaning activities in laboratory and pharmaceutical production settings.
Commissioning & Qualification
GxP guidelines require a science and risk based life cycle approach for processes, installations and instruments. An essential part of process validation is demonstrating that the systems used are under control throughout the life cycle.