Complete Validation Services
Serpa Packaging Solutions has engineered all of our machines to be ideally suited for the Pharmaceutical, personal care and medical device industries. Our cartoners, casepackers and tray packers were designed from the ground up to be validation friendly. Our internal design team, along with our validation group, is ready to assist you in your validation efforts. The following documents are utilized to complete your project validation.
We can provide you with a detailed set of GAMP documents including a Functional Requirement Specification, Detailed Design Document, and an FAT Protocol. We are prepared to take your User Requirement Specification and turn it into a complete documented system.
We can also provide the required Installation Qualification, Operation Qualification, and Performance Qualification protocols as required. Many of our customers can provide their own Line Qualification, and we can work along side those who have this in house capability, or we can provide it for you as well.
We are staffed and trained to help you execute the protocols in the field as well. A trained support staff can be assigned to assist in your execution of the required documents.
Regardless of your validation requirements, we are fully prepared to help you complete the job, from start to finish. Contact us for more information about our validation services.
We have partnered with SMB Validation & Compliance Group in order to meet all of your validation needs. For more information on validation, visit linevalidation.com.