We have designed our quality program to ensure that our data meets customers’ quality expectations and global regulatory compliance requirements. Through continuous improvement of our rigorous quality systems, review of quality control data using LIMS, internal lab audits, submission of check samples and review of lab data, our customers receive data that will hold up under the most stringent regulatory review.
Our Quality Assurance Department, working directly with our President, oversees and implements all aspects of our Quality Program.
Our program includes:
- A strict Quality Policy signed by all employees.
- Compliance with cGMPs, GLPs that includes training for all new employees and yearly refresher courses for all employees.
- Monitoring changes to regulatory requirements that impact the various aspects of our business to ensure our compliance with all current regulatory requirements.
- Routine internal audits of our facilities to ensure we are operating in compliance with regulatory guidelines and our quality program.
- Working cooperatively with our customers for timely resolution of Out Of Specification (OOS) investigations and quality issues.
- An extensive instrument, qualification, calibration and maintenance program.
Why Eurofins Lancaster Laboratories?
- With more than 50 employees in quality assurance roles, we offer you sufficient resources to monitor all lab processes and ensure that you receive timely, compliant and high quality data.
- Our 30 year history of cGMP-compliance assures you of the highest quality service.
- We have extensive experience working with global regulatory agencies such as FDA, IMB, EMA, PMDA, and INAB, with routine audits.
- We are accredited by The American Association for Laboratory Accreditation (A2LA).