Laboratory systems are a critical component of GMP compliance due to their role in product release, stability testing and validation support. For this reason, FDA and international regulators require a formal qualification program to ensure instruments conform to method requirements. This is particularly important for instruments running validated methods.
We offer efficient and affordable solutions for instrument qualification that satisfy the FDA’s requirements for laboratory compliance. We maintain a library of hundreds of protocols based on standard industry practices that can be customized to meet your quality requirements. This creates the optimal combination of quality and affordability that is often lacking in OEM qualifications.
All of our instrument qualification services are offered at a reasonable fixed price and can be combined with other services such as SOP development and integrated software validation. Our team of science and engineering professionals has the technical knowledge, regulatory background and applied laboratory experience to deliver high-quality, GxP-compliant solutions for your laboratory that won’t break your budget.
Our fixed price services include:
Turnkey service including all test equipment and calibration certificates
Comprehensive protocols that can be customized and are pre-approved by you