Validation & Testing
Patient safety is at heart of our business, always meeting quality demands and complying with legislation. Agidens is your valuable validation partner in the handling of GMP/GLP/ISO projects. Together we ensure that you remain within the guidelines and standards in force.
Agidens contributes to patient and consumer safety in close cooperation with its clients. With more than 25 years of experience in Pharma, Hospitals & Biotech, our Validation & Compliance consultants combine technical advice with sustainable solutions – always in line with current law and legislation.
HOW DOES VALIDATION & TESTING BENEFIT YOUR BUSINESS?
ValidAId is our proprietary AI-powered tool for a more time-efficient & accurate validation process. The AI tool is embedded in the workflow of our consultants to help them create quality validation documents, quickly process large sets of documents & summarize information.
Demonstrate compliance
Global regulatory agencies focus on the entire pharmaceutical supply chain. Manufacturers and distributors are obligated to guarantee that their products get to the patient under the required temperature conditions.
Patient safety & product quality are key
The production process of pharmaceutical products is subject to strict regulations. The law obliges manufacturers to provide documented evidence that the process yields a product that continues to meet the proposed requirements.
GxP guidelines
The 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.
TAKE THE FAST LANE
How do you make the right decisions about your different validation challenges?
Process & Cleaning Validation
In order to get stability in the production process, it is fundamental to detect and address any deviations. Our way of working is based on a quality by design’ approach.
Computer System Validation
CSV offers producers documented proof of compliant, consistent computerized/automated system performance. Our services provide advice and support for achieving this goal.
Commissioning & Qualification
In addition to years of practical experience, Agidens has the best knowledge of current industry practices and the latest developments in the area of GxP.
Thermal Validation
As the Life Sciences industry evolves, mastering temperature control & compliance is non-negotiable. Uncover the indispensable role of Thermal Validation services in providing tailored solutions for sterilization and controlled storage processes.
Analytical Instrument Qualification
Ensuring equipment reliability, analysis accuracy, and result integrity is crucial. We strive to comply with regulations to assist you in achieving this goal.
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 provides custom advice and support.
PROVEN EXPERIENCE,
DAY AFTER DAY AFTER DAY
FULFILL YOUR AMBITIONS
Let’s take the first step towards achieving your business goals. Fill out the contact form, and discover how Agidens makes sure that progress never stops.
READ OUR INSIGHTS
Statistical tools are crucial for process validation
Data-driven insights with Predictive Maintenance
Trusted Kneat Service Provider
We’re a trusted Kneat Service Provider. As a Kneat Service Provider we are skilled in the use of Kneat and may provide Kneat-related services, in line with our Kneat Academy Power User 1 certification level.
Completion of Kneat Academy Power User 1 program certifies that we have a strong understanding of Document Templates, Section Group Templates, Approval Templates, and Properties on the Kneat Gx platform. We are able to execute and update these elements for established processes for existing Kneat customers.
