Devices and test samples submitted to HIGHPOWER are tested in accordance with American or International standards, FDA guidance documents, internal written laboratory standard operating procedures, device specific validation protocols or study plans, as are appropriate.
Customer supplied product/samples are verified upon delivery for visual damage which may have occurred during transit and the information is recorded on internal forms along with the verification of contents.
A unique study number is assigned to each customer project. The study number is subsequently used on all associated raw data sheets, log books, laboratory notebooks, test protocols and HIGHPOWER final reports. Traceability and project status are maintained and tracked through the controlled study numbers and through a system of physical segregation at the test facility.
Laboratory procedures are carefully controlled to assure accurate testing and quality guidelines are strictly followed to assure valid test results. Original data are recorded in ink on signed, dated record forms or notebooks and are approved by a department manager or supervisor. Customers are promptly notified of adverse test results by fax, phone or email.
After study completion, a technical review is performed on all data, test procedures and final reports. Once the technical review is completed, a thorough review of the complete project is performed by a representative of the quality department. After QA review and signature, the original final report and a copy of the signed test protocol (if required) is provided to the customer via fax, email or mail. Customer are then invoiced for the cost of testing performed.
A copy of the final report and supporting data remain in the project study folder and are filed in the HIGHPOWER archives along with an electronic copy of the final report for a minimum of seven (7) years.