DeltaTrak’s qualification and validation services help customers validate DeltaTrak’s products as required by the Food and Drug Administration (FDA) and follow the General Principals of Process Validation and guidelines of Good Manufacturing Practices (cGMP).
Our services are provided to meet global regulatory standards, meet the needs of internal audit requirements and procedures, including installation qualification, operational qualification and performance qualification IQ/OQ/PQ.
Documentation includes detailed product descriptions, exercises, procedures, forms, check sheets, sign off requirements and supporting qualification information. Our installation qualification service includes validation of DeltaTrak’s software installation, check sheets for required documentation such as operating manuals, validation of the user’s manual complying with the customer’s standard operating procedures, listing of needed equipment and logon screen verification.
The operational qualification service 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 service 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.
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 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:
- FlashLink Data Manager
- ColdTrak Manager
- FlashLink RF 2.4 GHz Wireless System