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.
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
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.