At eLife Sciences, we specialize in the comprehensive qualification of both laboratory and production equipment, tailored to the requirements of regulated industries such as pharmaceuticals, biotechnology, and the medical sector. Our services ensure full compliance with applicable standards (GMP, GAMP 5, ISO) and prepare your equipment for safe and efficient operation.
The qualification process covers the full cycle, from planning and testing to complete documentation. We always adapt the scope of services to the specific equipment and the environment in which it will be used.
Verification that the equipment has been installed correctly according to design specifications and manufacturer recommendations.
Confirmation that the equipment operates according to defined operational parameters.
Confirmation that the equipment performs effectively under real operating conditions.
Ensuring that the equipment design meets quality and regulatory requirements.
In research and quality control laboratories, the reliability of equipment is crucial to ensure credible results. We offer the qualification of, among others:
Our services also include support in developing validation strategies for new technologies and adapting existing procedures to electronic quality management systems.
In pharmaceutical and biotechnological production environments, proper equipment qualification directly impacts the quality and safety of the final product. We conduct the qualification of, among others:
We also address specific requirements for calibration, utilities qualification, and integration with environmental monitoring systems.
