DeltaTRAK’s IQ/OQ/PQ qualification and validation program offers services and tools to help customers validate DeltaTRAK’s products as required by the FDA’s Good Manufacturing Practices (cGMP) or specifically the FDA Code of Federal Regulations Title 21.
On-Site Certification Courses
With the use of DeltaTRAK’s IQ/OQ/PQ qualification documentation a customer can follow established quality procedures to verify that the product installs, operates and performs as expected. When the procedures are completed the customer has documented evidence to support its validation plan. Customers can perform the exercises on their own or contract with DeltaTRAK to perform the validation process. DeltaTRAK offers on-site certification courses for select DeltaTRAK products. The certification courses are designed to prepare participants to meet cGMP criteria.
Documentation includes detailed product descriptions, exercises, procedures, forms, check sheets, sign off requirements and supporting qualification information. The installation qualification section includes verification of DeltaTRAK’s software installation, check sheets for required documentation such as operating manuals, verification of the user’s manual complying with the customer’s standard operating procedures, listing of needed equipment and logon screen verification.
The operational qualification section includes exercises to validate that the software can collect, store and generate reports on records correctly and accurately as compared to the validated references. It also validates that security functions are operating, reports and printing functions are working and signatures are recorded.
The performance qualification section includes documentation that equipment handling precautions are maintained and a calibration and maintenance schedule is established and documented. It also includes exercises to confirm that all sensors are accurate as compared to a NIST certified reference standard.
The IQ/OQ/PQ program documents that a DeltaTRAK solution is installed properly and operates as per DeltaTRAK’s specifications. It provides the customer with verification in documented form that the product is validated as defined in the FDA current Good Manufacturing Practice (21 CRF).
The IQ/OQ/PQ program is an objective documentation and qualification process available to DeltaTRAK customers using FlashLink and ColdTRAK products. The DeltaTRAK products that currently have IQ/OQ/PQ qualification are: