Validation

Lab Validation
The reliability of equipment, accuracy and the integrity of analysis results are of great importance in each laboratory. We support you with our solution-oriented, multidisciplinary consultants. Together we look after the installation, qualification and proper operation of your lab equipment and information systems.
Commissioning & Qualification
Whether it is now, at the design, development and installation stage, at the time of the initial commissioning, or qualification, operational use or decommissioning, Agidens Life Sciences is always at hand to provide advice and assistance. In addition to years of practical experience, we have the best knowledge of current industry practice and the latest developments in the area of GxP.
Compliance
GxP Advice
Agidens Life Sciences supports companies in the full preparation for audits and inspections by customers or by the government. For this, we analyse production processes and inspect work instructions and Standard Operating Procedures (SOPs) to examine them against the most recent regulations.
Testing & Inspection Services
Thermal Validation
The current health economics guidelines require processes to be demonstrably controlled. Whether it is sterilization, disinfection, or thermally controlled storage or distribution, companies must guarantee that processes comply with the required conditions. Agidens Life Sciences offers bespoke solutions for this.
HVAC/Cleanroom Validation
Cleanrooms, production facilities for pharmaceutical products, operation rooms, and LAF cabinets are subject to international legislation of the EU, FDA, and ISO 14644 Annex 1. This entails an obligation of validation and revalidation. Agidens Life Sciences provides advice and support from A to Z.
Transport & Cold Chain Validation
Global regulatory agencies focus on the entire pharmaceutical supply chain. Pharmaceutical manufacturers and distributers are obligated to guarantee that their products get to the patient, under the required temperature conditions. To demonstrate compliance, qualification and validation of essential components is a must.
Hospitals

Validation for Sterilization Departments
Hospitals invest in professional sterilization departments with a focus on quality. After all, a controlled disinfection and sterilization process promotes patient safety. Agidens Life Sciences supports these departments with a wide range of validation and qualification services.