A lot of times, especially when developing high levels of controls, companies in the industry feel that they need to do testing themselves. More and more companies are outsourcing the testing.
The fact is, a trusted vendor can do the calibrations and qualifications. Very often, vendors are the ones that set specifications for qualifications, so they are the best people suited to test. Validation can be done by vendors or contractors.
Regardless of who does the work, the company itself is responsible for defending the work. The company is responsible for the pre-approval, review, and the final approval process. When it is all said and done, the company owns the information. Whether it is calibration, qualification, or validation, the company’s Quality Assurance team is responsible for making sure that work is acceptable no matter who executed it.
USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.