Analytical Instrument Qualification
Agidens understands the critical importance of compliance with regulations and industry standards in the life sciences sector. Our approach focuses on ensuring that the used analytical instruments meet the highest levels of quality, safety, and efficiency – ultimately contributing to the safety of consumers and patients.
Ensuring equipment reliability, analysis accuracy, and result integrity is crucial. We strive to comply with regulations to assist you in achieving this goal.
OUR APPROACH TO LAB EQUIPMENT & ANALYTICAL INSTRUMENT QUALIFICATION
Agidens is your dedicated 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. We focus on Expert Lab Assessments and Lab Validation Services to provide the best possible service and results.
Expert Lab Assessments
We conduct thorough assessments to identify and address any gaps in compliance and efficiency within your laboratory environment.
- -GxP assessments
- Data Integrity assessments
- ISO 17025 assessments
- 21 CFR part 11
- Lean lab assessments (value stream mapping)
Lab Validation Services
Our validation services encompass various validation types, including equipment, process, method, cleaning, thermal, and computerized system validations, ensuring that your lab equipment consistently meets the highest standards.
- Equipment Validation
- Process Validation
- Method Validation
- Cleaning Validation
- Thermal Validation
- Computerized System Validation
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 appliances
- Release for use & periodic in-use validations
- Decommissioning support
- Accurate documentation according to applicable GDP rules
- Development of tailored validation plans, including URS, risk analysis, testing, and final report
Lab Qualification at major pharma siteRead more
TAKE YOUR ANALYTICAL INSTRUMENT QUALIFICATION TO THE NEXT LEVEL
Do you like our approach? We would love to hear from you!
As the Life Sciences industry evolves, mastering temperature control and compliance is non-negotiable. Uncover the indispensable role of thermal validation in providing tailored solutions for sterilization and controlled storage processes.
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.