Normally when our pharmaceutical manufacturing industry customers introduce the DX100P/DX200P (hereinafter referred to as DX-P), usually a so-called validation process is required. Although the validation is in general described as "the process of creating documented evidence that assures all parts of the equipment function properly and consistently when used together," it can make the applicable range or work scope unclear in some cases because it is a concept involving a wide range of GxP requirements. Therefore, to reduce the burden on customers and those who will be in charge of validation, Yokogawa provides validation protocol (IQ/OQ) forms needed when introducing the DX-P. The following explains the basic flow of validation with the Yokogawa-provided IQ/OQ.
First, a typical validation flow (from design qualification to performance qualification, shown herein), and scope of DX-P validation are shown below.
The validation protocol that Yokogawa provides covers Installation Qualification (IQ) and Operational Qualification (OQ) as stated above. IQ is generally defined as "the process to verify and document that equipment, measuring instruments, facilities etc. used for the production process are properly designed or selected, and accurately installed,"and OQ is defined as "the process to verify and document that systems and/or processes are operating as they are designed for within a predictable range of operating conditions."
For example, the following contents will be confirmed and documented through the IQ for the DX-P.
- All hardware, firmware, and documents
- The standard operating environment
- Basic components and installation
- Access to external memory media and Ethernet connection
- Functions of the menu screen and DISP/ENTER key
In addition, the following contents will be confirmed and documented through the OQ for the DX-P.
- Security, audit trail, and electronic signature functions
- Data acquisition and extraction functions
- System settings
- Alarm and relay functions
- Computation channel, reporting, and input correction functions
- FTP, e-mail, and Web functions
- USER key, snap shot, and barcode functions
The IQ/OQ for the DX-P describes each step for checking and documenting the above items, and the DX-P validation will be performed as you confirm and sign-off on the expected operation in each step. Also, the IQ/OQ is provided in the same manner as above for the standard software DAQSIGNIN that manages, browses, and otherwise manipulates DX-P data. By completing the IQ/OQ for both the DX-P and the DAQSIGNIN software, validation will be complete for the DX-P and the entire software system.
The DX-P validation protocol is available in digital format on CD-ROM or in paper format. Please contact your nearest representative for more details.
References:
The GAMP Guide for Validation of Automated Systems ISPE
