Your customers are asking how to validate your instrumentation or equipment, and your support staff is tied up with assisting this effort. Why not have a validation package that you can sell your customers?
Valicom has worked with many vendor validation packages and has learned what in them makes your customers’ validation efforts easier — or more difficult. We’re often called in to write supplemental protocols that either augment or supersede inadequate vendor validation protocols.
We therefore offer services to prepare turnkey validation packages that your company can sell its customers. These packages can include:
A list of general user requirements
IQ(s) for installation of equipment, instruments, hardware, and software
OQ(s) for confirmation that components function per specifications
PQ(s) that allow customers to confirm overall system performance with their unique process requirements
A traceability matrix to readily confirm that requirements have been validated
We’ve prepared entire validation packages for:
A manufacturer of digital microscope equipment, which validated customer installations of the microscopes as well as the controlling computers and servers in GxP environments.
A manufacturer of FDA-listed laboratory data acquisition software, which validated installations of software to demonstrate it performs in a manner that makes it suitable for in-vitro diagnostic use, as well as for other GxP applications
We’ve provided on-site services to execute these validation packages as well.
We’ve also assisted many other companies with updating their existing packages.
Please contact us to let us know how we can assist you!