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?
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.
JOIN THE AGIDENS x KNEAT WEBINAR ON PAPERLESS VALIDATION
We’re excited to partner with leading digital validation software provider Kneat Solutions during a one-hour webinar on Wednesday, June 28 (16:00) to show you how much value efficient lifecycle management brings to an organization.
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.
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.