One way to get a leg up on validation is to rely on vendors that can provide the engineering resources to create the required validation documentation. Such documentation should include the serialization qualifications, operational qualifications, and acceptance test protocols. The vendor should have the ability to execute those protocols.
Another technique is to follow Good Automated Manufacturing Practice (GAMP) and develop a User Requirement Specification (URS) that may form the basis for future validation materials.
The vendors, not the user companies, are the ones most knowledgeable around how their systems work. If the vendor does not provide validation documentation, then the pharmaceutical company must hire a third-party validation company that is not familiar with the technology. While those firms understand commodity technologies, they are unlikely to be familiar with specific serialization technologies, resulting in a cost exposure for the manufacturer.
